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- 2025-12-18 08:25:19
- Company
- ROS1-targeting 'Augtyro' under consideration for reimb
- by Eo, Yun-Ho Dec 03, 2025 08:42am
- A ROS1-targeting cancer agent, 'Augtyro,' will be considered for the insurance reimbursement listing.According to sources, Bristol Myers Squibb (BMS) Korea's Augtyro (repotrectinib) is expected to be considered for review by the Health Insurance Review and Assessment Service (HIRA)'s Cancer Drug Review Committee (CDRC), which will be this year's last.The submitted application for listing includes the drug's indication for ▲the treatment of adult patients with ROS-1 positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) ▲the treatment of patients (adults and children aged 12 years and above) with NTRK (Neurotrophic tyrosine receptor kinase) fusions in solid cancers.Augtyro is classified as a next-generation Tyrosine Kinase Inhibitor (TKI) designed to overcome the limitations of prior treatments. It was approved based on the TRIDENT-1 trial, which included four cohorts of patients with ROS1 or NRTK fusions, assigned to groups based on prior TKI treatment history.The ROS1 data were published in the New England Journal of Medicine (NEJM), and the latest follow-up results were presented at the World Conference on Lung Cancer (WCLC) in September. Notably, 58% (41/71 patients) in the patient group without prior therapeutic experience ("no prior experience") and 41% (23/56 patients) in the group with prior therapeutic experience.In the TRIDENT-1 trial, Augtyro demonstrated clinically significant effects in both first- and second-line settings for ROS1-positive NSCLC. Favorable clinical results were reported, including Progression-Free Survival (PFS) of 31.1 months and Overall Survival (OS) of 74.6 months in 'no prior experience' patients, and a PFS of 8.6 months and OS of 25.1 months in patients previously treated with a ROS1-targeting agent.Furthermore, Augtyro has a molecular structure that facilitates penetration of the Blood-Brain Barrier (BBB), showing effectiveness even in patients with brain metastases. The 12-month intracranial PFS rate was 91% in the first-line setting, and the intracranial Objective Response Rate (ORR) was 38%, with a 12-month intracranial PFS rate of 82% in the second-line setting.Although it was a single-arm clinical trial, resultan indirect comparison against approved agents for ROS1-positive advanced NSCLC showed that Augtyro achieved statistically significant improvements in ORR, Duration of Response (DOR), and PFS compared to existing therapies.Based on these clinical results, Augtyro is strongly recommended as a first- and second-line treatment option for patients with ROS1-positive NSCLC in all major guidelines, including NCCN, ESMO, and ASCO.Professor Sang-We Kim of the Department of Oncology at Asan Medical Center stated, "The TRIDENT-1 clinical trial showed superior results compared to existing treatment in both the 1st and 2nd line settings for ROS1-positive NSCLC. The results indicating that the use of Augtyro as a first-line treatment could potentially enable patients to survive for over five years are highly encouraging. We hope it will be added to the reimbursement list so that patients in need can benefit quickly."
- Company
- Antengene's 'Xpovio' passes the DREC
- by Eo, Yun-Ho Dec 02, 2025 12:38pm
- Xpovio (selinexor), an oncology drug and the first product introduced in South Korea by the Chinese pharmaceutical company Antengene Corporation Limited ("Antengene"), is entering the final stage for expanded reimbursement.According to sources, Antengene Korea has accepted the condition of 'below the evaluated price' set by the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) on November 6 for the oral Multiple Myeloma treatment, Xpovio (selinexor). The company is currently awaiting the Ministry of Health and Welfare (MOHW)'s order for price negotiation.The specific indication for the expanded reimbursement process is: 'In combination with bortezomib and dexamethasone for adult patients with Multiple Myeloma who have received at least one prior therapy.'Designated as an orphan drug in Korea and approved in August of last year, Xpovio is a novel mechanism drug that selectively inhibits the nuclear export protein, XPO1.XPO1 inhibitors are anticipated to be used in combination with other treatments (drugs, etc.) to improve the treatment of various diseases. Currently, five treatments, including Xpovio, are recommended in the National Comprehensive Cancer Network (NCCN) guidelines.Most Multiple Myeloma cases are characterized by having repeated recurrent/refractory responses to treatment. Similarly, in Diffuse Large B-cell Lymphoma (DLBCL) patients who fail systemic therapy, the opportunity for cure or long-term disease-free survival diminishes with each subsequent relapse.Consequently, there is an urgent need for safer and more effective treatments for both relapsed/refractory Multiple Myeloma and relapsed/refractory DLBCL.However, the final listing of Xpovio for insurance reimbursement is expected to take additional time. Xpovio was submitted to HIRA's Cancer Drug Review Committee (CDRC) in January but failed to secure the reimbursement criteria.The reason for failing at the CDRC is reportedly the failure to meet the required number of launched A7 countries (countries where the drug has been approved and marketed). As a result, the company must monitor the status in other countries before proceeding with a renewed reimbursement challenge.Meanwhile, the efficacy of Xpovio has been demonstrated through two Phase 2 studies: STORM and SADAL.In the STORM study, Xpovio in combination with dexamethasone showed an Objective Response Rate (ORR) of 26% and a Clinical Benefit Rate (CBR) of 39.9% in patients with relapsed or refractory Multiple Myeloma who had received four or more prior therapies.The SADAL study, which enrolled patients with relapsed DLBCL who had received two or more prior therapies, demonstrated an ORR of 28.3% and a Complete Response (CR) rate of 11.8% with Xpovio monotherapy.
- Policy
- First Migard generic listed in KOR
- by Jung, Heung-Jun Dec 02, 2025 12:37pm
- The first generic version of Migard will be listed for reimbursement in Korea next month.Frotriptan Tab, Myung In Pharm’s first generic version of SK Chemicals' Migard Tab, will be listed for reimbursement next month, marking the beginning of full-scale competition.With this listing, Myung In Pharm strengthened its position in the migraine market, alongside its existing products such as Sumatran (sumatriptan succinate) and Topamate (topiramate).According to industry sources on the 28th, Myung In Pharm’s Frotriptan Tab 2.5 mg (frovatriptan succinate monohydrate) will be reimbursed starting next month. As the first generic, it receives a 59.5% premium, with the upper reimbursement limit set at KRW 2,038.Last year, Myung In Pharm became the first domestic company to conduct a bioequivalence study for the launch of a generic version of Migard. It obtained the first generic approval this June.Migard is a migraine treatment containing frovatriptan that received domestic approval in 2009. It is used for the acute treatment of migraine with or without aura.According to the market research firm UBIST, Migard recorded KRW 2.5 billion in sales last year, representing a 16% increase from the previous year.With the entry of generics, SK Chemicals and Myungin Pharmaceutical will now compete in the previously uncontested misgraine treatment market.While Migard’s standalone sales may not suggest a large market, the broader triptan-class market, including agents such as sumatriptan, is not small. The acute migraine treatment market is estimated to be worth approximately KRW 23 billion.Several pharmaceutical companies, including Yuyu Pharma, Daewoong Bio, Han Wha Pharma, and Reyon Pharmaceutical, already market products containing sumatriptan, naratriptan, and other triptan-class ingredients.Myung In Pharm, known for its strong CNS portfolio, continues to expand its migraine lineup, adding Frotriptan to its existing line of products such as Sumatran (sumatriptan succinate), Topamate (topiramate), and Poxen (naproxen sodium).SK Chemicals, its direct competitor, has also been strengthening its migraine portfolio. In addition to Migard, it launched Suvexx, a combination of sumatriptan and the anti-inflammatory agent naproxen, last year. Also, in October last year, it further expanded its lineup by acquiring the original zolmitriptan product Zomig Tab from AstraZeneca.
- Opinion
- "Personalized first-line therapy for EGFR-mutated NSCLC"
- by Hwang, byoung woo Dec 02, 2025 12:37pm
- The treatment paradigm for EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) is changing.Given the high incidence of brain metastases at diagnosis in EGFR-mutated NSCLC, the key criteria for first-line treatment selection are now centered around Central Nervous System (CNS) inhibition and a favorable toxicity for long-term administration.The integrated analysis of LASER201 and LASER301, published recently in 'Clinical Lung Cancer,' provides additional evidence supporting the intracranial efficacy of the domestically developed third-generation EGFR TKI, Leclaza (lazertinib). The study is providing evidence for redefining the treatment strategy for patients with EGFR mutations.DailyPharm met with Professor Ji-Youn Han, from the Division of Hematology-Oncology at the National Cancer Center, a co-author of the paper mentioned above, to hear about the latest trends in the treatment of EGFR-mutated Non-Small Cell Lung Cancer (NSCLC), the CNS strategy, and the direction of customized therapy in the era of combination therapies."Brain metastases account for 40% at diagnosis…key determining factor for prognosis"Professor Ji-Youn Han, Division of Hematology-Oncology at the National Cancer CenterFirst, Professor Han emphasizes that "CNS management is now the starting point of treatment, rather than simply an additional factor."Professor Han stated, "Approximately 20-25% of all lung cancer patients already have brain metastases at diagnosis, but this rate rises to as high as 40% in patients with EGFR·ALK·HER2 mutations or who are non-smokers," and added, "Recent global Phase 3 (MARIPOSA·FLAURA2) trials also reported that 40% of patients have baseline brain metastases."These data indicate that not only are baseline brain metastases common, but a significant number of participating patients with good performance status have accompanying brain metastases.However, the prognosis varies significantly depending on symptom status. While approximately 40% of brain metastases cases are detected while still asymptomatic, the prognosis rapidly worsens once neurological deficits occur.Professor Han stated, "Symptoms of brain metastases include persistent headaches, nausea/vomiting, visual impairment, dizziness, and stroke-like symptoms, which severely limit daily life. Ultimately, symptomatic brain metastases is regarded as a major worsening factor that significantly decreases the patient's Quality of Life."Integrated Analysis of LASER201/301...reconfirming Leclaza's effect on suppressing the CNSProfessor Han summarized the limitations of existing first- and second-generation EGFR TKIs as being 'not initially designed to target the EGFR mutation itself.'Professor Han explained that side effects from inhibiting normal EGFR made it difficult to achieve sufficiently high drug concentrations, resulting in restricted BBB permeability and, consequently, a structural limitation in CNS management.In contrast, third-generation EGFR TKIs were developed from the start to enhance mutant EGFR selectivity and BBB permeability. This gained attention because it opened an era where much more stable and consistent effects on CNS can be expected, even in patients with brain metastases.Furthermore, the differences in toxicity profiles are evident. Professor Han said, "If the clinically perceived toxicity severity of first·second generation agents is rated at 10, the third generation is at the 2–3 level, which significantly improves their suitability for long-term use."Regarding the results of the LASER201 and LASER301 integrated analysis released, Professor Han evaluated them as additional evidence supporting Leclaza's global competitiveness.Professor Han stated, "The key finding is that this study provided objective data confirming that Leclaza has intracranial efficacy comparable to Tagrisso (osimertinib), the Korean standard of care, in EGFR-mutated lung cancer patients with brain metastases." She found this consistent with the trend from the MARIPOSA study, in which lazertinib monotherapy showed a Hazard Ratio (HR) of less than 0.9 compared to osimertinib in this patient group.Professor Han also mentioned, "Although the two drugs have generally similar efficacy, their side effect profiles do not entirely overlap. The fact that an option exists for patients to switch to the other drug if they cannot tolerate a specific adverse event is a major clinical advantage."Consequently, the availability of two third-generation EGFR TKIs is viewed as having significance for expanding the treatment strategy.Leclaza has a demonstrated advantage for suppressing brain metastases, supported by clear data proving the BBB permeability in preclinical studies.Professor Han stated, "This integrated analysis strengthens Leclaza's intracranial evidence, enhancing its global credibility, and expands the treatment strategy by enabling customized drug selection based on the patient's side effects and status. It is significant because it lays the foundation for broadening the scope of clinical judgment amid the future flow of combination therapies and new drug development."Toxicity management and drug switching...differentiating strategy garners attentionProfessor Han stressed that 'toxicity management' is a critical factor in determining the actual clinical treatment strategy, as EGFR-mutated lung cancer is a disease that requires long-term use of agents from the same class.In the case of Tagrisso, specified severe side effects, such as thrombocytopenia, ILD (interstitial lung disease), and cardiac toxicity like QTc prolongation, may necessitate dose reduction."According to the current guidelines, dose must be reduced to 40 mg if the same adverse event recurs. However, the evidence for maintaining drug efficacy at the 40 mg reduced dose is extremely limited, and the lack of data ensuring sufficient CNS control in patients with brain metastases is the biggest concern in the clinical setting," she said.Professor Han said, "Since CNS progression in EGFR-mutated lung cancer is directly linked to treatment failure, disease progression during dose reduction significantly limits the scope of subsequent drug switching strategies." She emphasized, "The medically recommended option in this scenario is a switch to Leclaza monotherapy, whose efficacy and tolerability have already been proven at the standard dose (240 mg)."Professor Han also suggested that the reimbursement criteria need be improved.The current reimbursement criteria require a Tagrisso dose reduction before switching to Leclaza, forcing the patient to risk the same side effects again. Professor Han also pointed out that if the disease progresses during the dose reduction, reimbursement for the subsequent switch to Leclaza may be denied.Professor Han concluded, "Since there is little difference in the drug price between the two agents, and Leclaza is sometimes even cheaper, there is insufficient evidence to mandate dose reduction for financial reasons," and added, "Ultimately, these regulations are criticized as being unreasonable from the perspectives of patient safety, treatment continuity, and insurance finances."
- Policy
- Biannual post-listing price cuts to be made
- by Jung, Heung-Jun Dec 02, 2025 12:35pm
- Price reductions under the post-listing management system, including price-volume agreements, will be consolidated into twice-yearly adjustments, significantly reducing uncertainty over price fluctuations.However, with the reduced frequency, large-scale price adjustments in both the first and second halves of the year have become inevitable.While the practice of lowering drug prices after actual transaction price investigations—a longstanding industry grievance—will be abolished, the incentive for low-price purchases will increase 2.5-fold, potentially triggering cutthroat bidding competition in large hospital tenders.The Ministry of Health and Welfare (MoHW) announced its drug-pricing reform plan on the 28th and will collect opinions through Q1 next year before implementing changes in July. Dailypharm reviewed how the reform, especially the post-listing management restructuring, will affect the field.Post-management overhaul: Drug price cuts in April & October... will reduce uncertainty but bring larger-scale adjustmentsFrequent drug price reductions under various post-management systems caused confusion in the field.Going forward, the timing for post-management price adjustments will be fixed annually in April and October, making it easier for the field to prepare for price changes.Even within the PVA system, reductions previously occurred at different times depending on the category (A/B/C), leading to complaints about constant adjustments. Price cuts driven by increased utilization after indication expansion or reimbursement expansion were also applied on a rolling basis throughout the year.Starting in 2027, the consolidation to twice-yearly adjustments is expected to eliminate these complaints. However, since drug price adjustments will be reduced to once per half-year (first and second half), large-scale reductions will be unavoidable each time.From the pharmacy's perspective, while the confusion caused by the unpredictable timing of price reductions will be resolved, the workload is expected to increase with adjustments occurring only once per half-year.The actual transaction price cut will be eliminated because the government views the administrative burden as excessive relative to the benefit. Instead, the incentive for low-price purchasing will increase from 20% to 50%, with the intent of inducing price competition that naturally lowers transaction prices.While the industry welcomes the abolition of actual transaction price reductions, it expresses concern over the incentive expansion policy. This is because, considering the de facto dominant-subordinate relationship between large hospitals and pharmaceutical/distribution companies, adverse effects are anticipated.If the incentives received by medical institutions increase by approximately 2.5 times, the demand for lower prices will grow, and the industry fears an increase in cutthroat competition where losses must be absorbed.The industry's primary demand is for supplementary measures, such as minimum price floors and eligibility review systems.Preemptive measures for 2012 adjusted drug price reductions... Companies with post-2013 listings express anxietyThe government will take preemptive action on products that have maintained the 53.55% price level for 13 years since the 2012 blanket reduction.If the reform is finalized as is, HIRA will select eligible products among the 6,500 that were reduced in 2012, review them, and begin applying new price cuts.The following are excluded from the price reduction targets: ▲ Drugs receiving premium pricing ▲Exit-prevention drugs, low-cost drugs, and orphan drugs ▲ Drugs listed exclusively ▲ Drugs whose prices have increased in the last 5 years due to supply instability ▲ Basic infusion solutions and radiopharmaceuticals ▲ Oxygen and nitrous oxide.Pharmaceutical companies holding items listed since 2013 are also excluded from immediate measures, but they worry the government might expand the scope of price reductions.Furthermore, in the second half of next year, the uniform surcharge for generic drug listings will be abolished, replaced by a differential surcharge based on innovation and contribution to supply stability. As the first half of the year represents the last opportunity for listing, applications are expected to flood in during the first and second quarters.Moving forward, the R&D-to-sales ratio will become crucial for receiving drug price premiums. Differential premiums will be applied based on criteria such as the top 30% and bottom 70% of innovative pharmaceutical companies. Companies hovering ambiguously near the cutoff line are likely to engage in a game of brinkmanship over the extent of their R&D investment expansion.As no absolute numerical threshold is set, the government appears to anticipate a competitive surge in R&D investment.Stepped price reductions for generics will also be strengthened. Currently, the price of the 21st generic is set at 85% of the lowest price. This will be applied starting from the 11th generic. The intent is to reduce prices by 5% each step from the first generic's calculated price to prevent indiscriminate proliferation of generics.This reform is particularly painful for small and medium-sized pharmaceutical companies, as the government's clear goal is to induce new drug development through strict generic drug price management and to transform the industry ecosystem, which is overly reliant on copy drugs.If companies conclude that obtaining add-on pricing will be difficult and that the benefit of listing is reduced, they may shift more aggressively toward non-reimbursed products.
- Policy
- Gvn’t ‘No blanket drug price cuts will be made’
- by Lee, Jeong-Hwan Dec 02, 2025 12:34pm
- Yeon-sook Kim (Director of the Pharmaceutical Benefits Division), Joong-kyu Lee (Director-General for Health Insurance Policy), and Gi-heon Bae (Deputy Director, Pharmaceutical Benefits Division) from MOHW explained the details and intent of the drug price reform plan. "During the blanket drug price reduction, prices of approximately 6,000 items were cut. Since then, 13 years have passed, and 4,500 items have either not been reduced at all or only reduced to 45% from 53.55%. Starting next year, the price reductions will be made over the next 3 years to these 4,500 items. There is little room for debate about price cuts over these listed generics since they've been generating excessive profits for over a decade. The remaining 15,000+ already-listed generics are not targets for this price reduction. We plan to review the other listed generics only after completing the adjustment process for the initial 4,500 items. ‘Reviewing’ does not mean we intend to cut their prices."As the government unveiled a plan to lower the generic price rate from 53.55% to the 40% range of the original drug’s price, it confirmed that prices of 4,500 pre-listed generics will be cut first when the reform is implemented in the second half of next year (July). The expected savings in National Health Insurance drug expenditure from this measure amount to KRW 1 trillion.Based on the 6,000 items subject to the 53.55% blanket generic price reduction applied in 2012, the plan targets 3,000 items whose prices have barely decreased (maintaining 53.55%~50%) since then up to the present (2025), and 1,500 items that saw only a slight decrease (maintaining 50% to 45% range). The plan is to reduce prices to the 40% range over 3 years, targeting only these items.For the 3,000 generics maintaining prices between 53.55% and 50%, adjustments will begin next year (2026) and will be reduced to the 40% range by 2028. The 1,500 generics in the 50% to 45% range will begin adjustments the year after next (2027) and be reduced to the 40% range by 2029.The government has clearly stated that it will not reduce the prices of generics listed from April 2012, when the blanket price reduction for generics began, to July next year, when the reform plan takes effect, at least until the price adjustments for 4,500 items are completed.However, starting in 2030, when the price reduction process for the 4,500 items concludes, the government intends to establish a mechanism to periodically review generics listed between April 2012 and June 2026 to assess the need for price adjustments.On the 30th, Joong-kyu Lee (Director General for Health Insurance Policy), Yeon-sook Kim (Director of the Pharmaceutical Benefits Division), and Gi-heon Bae (Deputy Director, Pharmaceutical Benefits Division) held a briefing with the MOHW press corp to explain the sequential adjustment plan for pre-listed generics.4,500 drugs to see 40% price cuts by 2029... “KRW 1 trillion in drug cost savings”The Ministry expects that reducing the prices of 4,500 existing generic drugs by around 40% over the next 3-4 years, starting next year, will yield savings of approximately KRW 1 trillion in National Health Insurance finances.Lee explained, “These 4,500 generics have kept their prices unchanged for more than 10 years since 2012 and have enjoyed excessive profits. The need for reduction is hardly disputable.”Simply put, since this generic drug price reduction targets only 4,500 items out of the 6,000 that underwent a blanket price reduction in 2012, it is unlikely to provoke significant backlash from the domestic pharmaceutical industry. It's essentially saying, ‘These generics deserve the cut.’But the Korean pharmaceutical industry strongly disagrees.They argue that maintaining the 53.55% price level required real investment efforts, such as conducting their own bioequivalence tests and registering DMFs (Drug Master Files), and meeting various regulatory criteria. Therefore, criticizing the price as excessive profit and cutting it simply because it wasn't reduced amounts to the Ministry of Health and Welfare itself, negating the tiered pricing system it has set standards and requirements for.Moreover, while the price reduction mechanism for multinational pharmaceutical companies focused on original products converges to zero, the Ministry announced it would accept systems favored by multinationals—such as the flexible pricing contract system that allows different listed and actual transaction prices, and the differential pricing system by indication. This has led to cynical reactions within the pharmaceutical industry, including “a reform plan that cuts domestic generic drug prices while further bolstering prices for imported originals.”Lee Jung-kyu: “The focus of the reform plan is on rewarding innovative R&D, not restructuring generics.”Director-General Lee emphasized that the reform plan's significance lies in encouraging innovative new drug R&D (research and development) rather than restructuring domestic pharmaceutical companies or domestic generics. He stressed that it aims to overhaul the drug pricing system into one that “favors as hard as possible” the drug prices for companies developing and producing medicines with unstable supply, namely essential medicines and market exit prevention drugs.He specifically clarified that at the current phase, the government is not considering price reduction mechanisms for generics listed between April 2012 and June 2026. This does not mean the prices of these existing generics won't be cut, but rather that after reducing prices for the initial 4,500 drugs, the necessity for further reductions will be discussed and considered with the pharmaceutical industry.The implication is that plans for handling the prices of these existing generics, which were not touched this time, will be determined gradually going forward.Domestic pharmaceutical companies maintain that retroactively applying the 40% generic drug price reduction reform to listed generics is unreasonable. Should the Ministry of Health and Welfare proceed with adjusting prices for generics listed since 2012, industry backlash is expected to be even stronger than it is now.Lee stated, “Currently, generics approved in 2012 are the target for price reductions. The 15,000 generics listed afterward will be reviewed later. This does not mean we intend to reduce prices periodically. It means we will thoroughly review the status of all generics listed in Korea.”He further emphasized, “The fact that 4,500 generics either maintained their prices at the 53.55% level or saw reductions of only up to 45% might warrant an audit from the perspective of the Ministry of Health and Welfare's National Health Insurance Policy Bureau and Pharmaceutical Benefits Division. We will regulate generics that have not seen price reductions for over a decade and have generated excessive profits.”Lee stated, “In 2012, the specific goal was to unilaterally reduce generic drug prices across the board. Yet, the amount of reduction made was not significant. This reform is not about restructuring generics; the policy direction is to properly support pharmaceutical companies excelling in new drug R&D and stable supply. It is an administrative measure to naturally reduce the prices of simple generics and incentivize their elimination from the market.”Preferential pricing for essential drugs, exit-prevention drugs, and domestic raw materials is also being discussed… “Active substitution to relieve public anxiety”To incentivize R&D, the reform links pricing with the “Korea Innovative Pharmaceutical Company” certification—the top 30% of certified companies by R&D-to-sales ratio will receive additional benefits. MoHW also emphasized support for companies producing essential medicines and exit-prevention medicines.Lee, Kim, and Bae all explained that efforts were also made to include measures to revive the struggling domestic raw material industry within the drug pricing system reform plan. Lee stated, “We hope it will be effective, but it is difficult to predict whether the essential drugs, withdrawal prevention drugs, and domestic raw materials sectors will function properly once the actual reform plan is implemented. We deliberated on creating a drug pricing system that benefits domestic raw material pharmaceutical companies, though some already consider it too late. For now, we will establish a system to protect the domestic industry from a public health security perspective.”Lee specifically outlined a vision to support the smooth prescription and dispensing of unstable-supply drugs on-site, alongside the drug pricing system reform.Specifically, the Ministry of Health and Welfare plans to use prescription-related systems to notify about supply instability and guide substitution with equivalent drugs within the list.Furthermore, the Ministry will establish the legal basis for building and operating a public information system to support post-prescription information sharing between pharmacists and physicians for smooth substitution dispensing, and will also build the information system itself.Lee stated, "When drugs with unstable supply are monitored, we will take administrative action to ensure substitution dispensing occurs actively. Doctors only prescribe the specific drug they intend, and when that drug runs out, they tell the media there's no medicine available. This creates a problem where the public feels anxious even when substitute drugs exist. We have focused significant effort on preventing such situations, ensuring a stable supply of essential medicines, and establishing a supply safety net to avoid triggering public anxiety."
- Company
- "First, dual-acting IL-23 inhibitor emerges in KOR"
- by Son, Hyung Min Dec 02, 2025 12:34pm
- "Inflammatory Bowel Disease is not a disorder that ends with improved symptoms. The long-term prognosis can be changed only when endoscopic and histological inflammation are also controlled."Professor Byong Duk Ye, from the Department of Gastroenterology at Seoul Asan Medical Center, stressed the need for new treatment mechanisms, given the high rates of relapse and refractory patients.The therapeutic goal for Inflammatory Bowel Disease (IBD) is expanding beyond simple symptom relief to 'deep remission,' which includes achieving both endoscopic remission and histological remission. Janssen's Tremfya (guselkumab), with a dual-action mechanism that blocks both the IL-23 signal and its pathway, has recently been approved in South Korea for both Crohn's disease and ulcerative Colitis, emerging as a new therapeutic option.Professor Byong Duk Ye from the Department of Gastroenterology at Seoul Asan Medical CenterProfessor Ye stated, "Given that a significant number of patients experience recurrent relapse and refractoriness despite utilizing all existing drugs, the introduction of a new-mechanism drug aiming for deep remission holds immense significance in clinical practice."IBD is a chronic inflammatory disorder of the intestines, broadly categorized into ulcerative colitis and Crohn's disease. Ulcerative colitis is confined to the colon, while Crohn's disease can cause inflammation throughout the entire gastrointestinal tract, from the mouth to the anus.The etiology of both diseases has not been defined. Due to the chronic, relapsing-remitting nature of the inflammation, the bowel can be damaged over several years to decades, leading to various complications.Given the difficulty of achieving a cure, the fundamental goal of IBD treatment is to effectively suppress inflammation and maintain a stable state of remission to minimize intestinal damage and complications. Although various drugs, including Janus Kinase (JAK) inhibitors and biologics, have been introduced, a complete cure remains challenging.Analysis suggests the domestic approval of Tremfya contributed to expanding treatment options. Tremfya is the first and only dual-action IL-23 inhibitor approved in Korea for both Crohn's disease and ulcerative colitis.Professor Ye said, "IBD treatment has continuously advanced, but the patient population continues to grow, and there are patients who don't respond or experience relapse after using all existing drugs," and added, "The introduction of a new-mechanism drug is welcome news for both patients and healthcare providers."Q. Why is remission still challenging to achieve despite the development of numerous IBD treatments?The biggest reason is that the disease's etiology has not been fully elucidated. The inflammatory pathways are highly diverse and complex, making it difficult to block all inflammatory routes at the same time with currently available drugs.Furthermore, blocking a specific inflammatory pathway can sometimes lead to the compensatory activation of other pathways. This is why some patients initially show treatment efficacy but experience disease worsening over time. In such cases, it may become necessary to switch the drug or adjust the treatment dosage.Ultimately, because the mechanism of inflammation is multilayered and not fully understood, current therapies alone are insufficient to fundamentally cure the disease. Nevertheless, recently developed agents are based on mechanisms that more precisely target inflammatory pathways, leading to a steady increase in the number of patients maintaining long-term remission.Q. Tremfya's domestic approval has expanded treatment options. Please explain the mechanistic advantages of this drug.IL-23 is a known cytokine that plays a vital role in the development of inflammation in both Crohn's disease and ulcerative colitis. Consequently, several antibody therapies have been developed to block IL-23 action, all designed to target IL-23 p19 subunit.Tremfya is unique for its dual-acting mechanism, which includes an additional mechanism targeting immune cells. Tremfya is the only IL-23 inhibitor that acts directly on CD64+ immune cells that produce IL-23. The Fab region of the Tremfya antibody binds to the IL-23 p19 subunit to block the inflammatory signal, and the Fc region binds to the receptor on CD64+ immune cells, suppressing the activation and function of these immune cells.Tremfya is a drug with a dual-acting mechanism that both blocks the signal molecule causing inflammation and suppresses the activity of the cells generating that signal. This structural feature is a unique strength of Tremfya, not present in other interleukin-23 p19 blockers.Q. Tremfya demonstrated superiority over Stelara in Crohn's disease. Could you please explain which clinical endpoint we should focus on?The Phase 2/3 GALAXI clinical trial in Crohn's disease included endoscopic response as a primary efficacy endpoint. Endoscopic response assesses the degree of improvement in intestinal inflammation via endoscopic scores, while endoscopic remission signifies a more advanced state where the damaged intestinal mucosa has recovered to near-normal.Deep remission is defined as the simultaneous achievement of clinical remission (symptom resolution) and endoscopic remission (mucosal healing). The GALAXI study assessed these measures as both individual and composite endpoints.The study results showed that at the one-year maintenance timepoint, Tremfya demonstrated significantly superior results compared to Stelara (ustekinumab) across endoscopic response, endoscopic remission, and various composite indices. Endoscopic metrics are objective indicators reflecting the level of inflammation control more accurately than subjective patient symptoms. This improvement holds critical significance for long-term complication prevention and prognosis enhancement.Q. What is the practical meaning of achieving deep remission (achieving both clinical and endoscopic remission) for patients?Deep remission is significant because IBD is a chronic disease requiring lifelong management, and it can prevent long-term complications. When symptoms improve, patients are freed from pain, diarrhea, and bloody stools, finding comfort in daily life and improving their overall Quality of Life (QoL). Achieving endoscopic remission also suppresses bowel inflammation that the patient may not consciously recognize, thereby reducing the risk of relapse or complications from intestinal damage.In other words, deep remission is a key goal that goes beyond mere symptom alleviation, improving the long-term course of the disease and reducing the likelihood of recurrence. Therefore, in clinical practice, there is continuous emphasis on the need for both symptom improvement and improved endoscopic findings to maintain a good state. Recently, patients are also increasingly aware of the importance of 'deep remission' and actively pursuing it as a treatment goal.Q. The efficacy of Tremfya has also been proven in ulcerative colitis. How would you evaluate the clinical value of this finding?The Phase 3 QUASAR clinical trial in ulcerative colitis evaluated not only endoscopic remission but also histological response and histological remission. Histological evaluation is a quantitative assessment of the presence and degree of inflammatory cells in the intestinal mucosa by microscopic observation.The study results showed that Tremfya demonstrated significantly superior results compared to the placebo group in endoscopic remission, histological improvement, and histological remission rates.Histological evaluation is becoming important in ulcerative colitis because these indicators are closely associated with long-term QoL improvement and the prevention of relapse and worsening.Even when inflammation appears almost resolved on endoscopic examination, tissue biopsy results may show residual inflammation. Studies consistently report that these patients have a higher frequency of relapse and a greater risk of emergency room visits during long-term follow-up. While histological remission is not yet an officially established treatment goal, as evidence accumulates, it is likely to be elevated as a new therapeutic goal.Q. What types of patients in the clinical setting in South Korea can be treated with Tremfya?Based on pivotal study designs, Tremfya is expected to be effective in patients who have not used both biologic- and small-molecule-agents and those who have previously used these agents. Therefore, it is a drug that can be widely utilized not only as a first-line therapy but also in the second-line and beyond treatment phases.Furthermore, agents targeting the IL-23 p19 subunit demonstrate a superior safety profile, offering a clinical advantage for patients requiring long-term treatment by reducing concerns about side effects.The maintenance dosing schedule of once every 8 weeks also enhances patient convenience. Moreover, while some existing oral medications have restrictions requiring discontinuation during pregnancy or childbirth, there is an expert consensus that Tremfya treatment can be continued through pregnancy, birth, and lactation. This positions it as an essential drug that expands treatment options for women of childbearing age and young female patients.Q. Considering clinical practice, patients, and policy, what are the unmet needs that should be addressed in IBD treatment?First, considering healthcare providers, there is a need for the broader dissemination of the understanding that the IBD treatment goal has been elevated beyond simple symptom improvement to the fundamental control of inflammation itself. This is a key concept for improving long-term prognosis and preventing complications, but it is not yet applied at the same level across all clinical settings.Furthermore, improving adherence to long-term therapy remains a significant challenge. Despite IBD being a chronic, lifelong disease, many patients stop taking medication or delay hospital visits once their symptoms improve. Therefore, spreading awareness that consistent treatment and management are necessary, even without symptoms, is essential.Finally, the hurdles to treatment access need to be lowered. Although Korea's 'Special Case Medical Expense Coverage System' allows eligible CD/UC patients to receive reimbursed biologics or small-molecule drugs with only a 10% co-payment, the initial entry hurdle for these agents remains relatively high. Additionally, the criteria for drug switching are stringent, and improvements are needed to allow for more flexible adjustment of treatment strategies based on the patient's condition.
- Company
- K-Medtechs accelerate North America expansion
- by Hwang, byoung woo Dec 02, 2025 12:34pm
- RSNA2025 site (RSNA Webpage)At this year’s Radiological Society of North America Annual Meeting (RSNA 2025), Korean medical device and AI companies fully unveiled their research achievements and platform capabilities, outlining concrete strategies for global market expansion.In particular, solutions addressing real-world issues in radiology workflows—such as interpretation discrepancies, diagnostic errors, and data bottlenecks—have increased, clearly shifting the focus toward clinical value.K-AI accelerates efforts to secure trust in the North American market with clinical dataRSNA 2025, the world's largest event gathering of radiologists and global healthcare companies, is being held in Chicago, USA, from November 30 to December 4.Marking its 111th year, this year's event, themed ‘Imaging the Individual’ (advancements in medical imaging technology for personalized diagnosis and treatment), showcases the latest trends in AI-based radiology devices, medical imaging equipment, and software.While RSNA has traditionally been a platform for global conglomerates to showcase hardware-centric technological prowess, Korean companies, particularly AI firms, are increasingly leveraging the event as a stage to demonstrate both technological capabilities and clinical reliability.First, Lunit, a leader in the AI field, clearly established its presence as one of the companies that secured the most research presentations, including 14 research abstracts. Notably, 8 of these abstracts were oral presentations, placing Lunit’s achievements in the upper tier even by North American academic standards.The oral presentations included studies on shifting the breast cancer screening paradigm from AI-supported double reading to AI-supported single reading, as well as research on how changes in breast density affect calibration of risk-prediction models.(Clockwise from top left) Deepnoid, Lunit, Crescom, Heuron – RSNA 2025 participant overviewLunit, operating its first integrated booth with Lunit International (formerly Volpara) since brand integration, plans to showcase its full-cycle AI solutions—from cancer diagnosis to risk prediction—based on this academic credibility, accelerating its expansion into the North American market.Deepnoid introduced 5 research abstracts focused on AI reliability, interpretability, and reproducibility, including addressing performance gaps in chest X-rays and error detection using vision-language models. It also plans to concentrate on sharing academic achievements and laying the groundwork for global market entry through its exhibition booth.Heuron presented solutions for diagnosing acute stroke and degenerative brain diseases, along with research achievements based on vascular-imaging CT. Musculoskeletal AI specialist Crescom showcased MediAI-BA, a bone-age assessment solution using hand X-ray, and its MediAI-OA quantitative knee osteoarthritis analysis solution, targeting the musculoskeletal-specific market‘Real-world use-focused’ strategy…Trend shifts toward platform and workflow efficiency enhancementWhile some companies demonstrated technological prowess through research achievements, others focused on resolving bottlenecks in clinical workflows within their specialized domains.Coreline Soft exemplified this approach by demonstrating its advanced chest AI platform, AVIEW 2.0, emphasizing its integrated workflow and improved efficiency.Coreline Soft AVIEW 2.0AVIEW 2.0 is designed so that interpretation, reporting, and explanation occur seamlessly within a single interface, offering a practical solution that drastically reduces communication steps that typically consume significant clinical time.Building on these achievements, major US medical institutions like UMass Memorial Medical Center have begun adopting AVIEW in routine radiology workflows, contributing to demonstrating the company’s tangible progress in the North American market.Additionally, MaiHub, Korea's first integrated medical AI platform company, made its debut at this year's RSNA to showcase its AI solution integration strategy.MaiHub emphasized a differentiated strategy centered on its medical AI integration platform maiLink, and the patient-facing AI analysis report app, maiReport. This strategy involves providing various AI solutions integrated on a single platform and delivering personalized patient reports.The company particularly emphasized its package-based AI-solution offerings designed to enhance partner companies’ market access and reduce the burden of AI adoption for clinicians. MaiHub is currently preparing for U.S. FDA 510(k) clearance next year, fueling expectations for the expansion of global partnerships. Samsung Medison focuses on securing ‘diagnostic consistency,’ increases presenceWhile AI companies showcased capabilities centered on software technology, Samsung Medison is targeting the market with next-generation imaging solutions that enhance the accuracy and consistency of diagnostic imaging.Samsung Medison unveiled R20, its first premium ultrasound diagnostic device dedicated to radiology, in the US market, and emphasized its high-resolution technology.The core technology of the R20 is 3rd-harmonic–based image processing. By using frequencies three times higher than the base signal, it delivers clear and stable images regardless of a patient’s body type, age, or sex, thereby reducing interpretation variability between examiners.(From left) Samsung Medison, Heuron’s RSNA 2025 boothsIt also incorporates deep learning-based real-time AI assistance designed to detect and visualize areas of interest in real time.Samsung additionally showcased a different approach focused on patient safety and operational efficiency. Alongside low-dose X-ray technology, the company introduced features aimed at reducing retake rates.Kyu Tae Yoo, GM & Global Head of Healthcare Business at Samsung Electronics and CEO of Samsung Medison, said, “Samsung is concentrating its technological capabilities on solving challenges raised in clinical settings, such as image-quality variation tied to patient characteristics. By advancing AI features and low-dose technology, we aim to enhance diagnostic efficiency and patient safety simultaneously, establishing a new standard in the medical imaging market.”Global leaders demonstrate strength… GE and Canon unveil new technologiesMeanwhile, global companies also showcased new technologies at RSNA 2025, maintaining the broader trends of imaging precision, operational efficiency, and data-driven diagnostics.Canon Medical Systems attracted attention with the world’s first multi-position CT, designed to meet practical, real diagnostic needs at the point of care.Overcoming the limitation of conventional CTs requiring patients to lie down for imaging, this equipment enables scans while patients are standing or seated in a special chair. This is expected to help identify causes previously detectable only under weight-bearing posture and contribute to the early detection of physical function decline in super-ageing populations.Yoo Eegeun, Head of Canon Medical Systems Korea’s CT Division, said, “With the introduction of the world’s first multi-position CT at RSNA this year, Canon Medical is presenting a new paradigm with a truly innovative technology that addresses practical needs in the medical field. We will strive to bring this innovation to the domestic market as quickly as possible.”(From left) GE Healthcare RSNA 2025 booth, Canon Medical Systems Multi-Position CTGE Healthcare, building on its symbolic history of 111 consecutive participations since RSNA's inaugural event in 1914, specifically unveiled the outcomes of its R&D investments exceeding USD 3 billion since 2022.Specifically, the company unveiled “Photonova Spectra,” a next-generation photon-counting CT (PCCT) system, and “SIGNA Sprint,” an advancement within its next-generation SIGNA MRI line.GE Healthcare CEO Peter Arduini said, “Our mission in shaping the future of healthcare is clear: to provide innovative technologies that support clinicians, enhance operational efficiency, and improve patient outcomes.”
- Policy
- Will incentives for low-price purchasing be expanded?
- by Jung, Heung-Jun Nov 27, 2025 06:14am
- Concerns are emerging that expanding low-price purchase incentives without safeguards could lead to a market collapse, ridden with ultra-low-price bidding wars, eroding the entire pharmaceutical ecosystem. The criticism is that a system focused solely on price competition directly contradicts the government’s stated goals of encouraging pharmaceutical and biotech R&D. According to industry sources on the 25th, the government’s upcoming drug-pricing reform package is expected to include a substantial expansion of low-price purchasing incentives. The low-price purchase incentive is a system where, if a healthcare institution purchases a drug at an actual transaction price lower than the reimbursement ceiling, a portion of the price reduction is provided as an incentive payment. Approximately 20-30% of the price difference is paid to the healthcare institution based on the incentive payment standards announced by the Ministry of Health and Welfare. Although the specific details remain undisclosed, one option being discussed is maintaining the current rule of not lowering drug prices based on actual transaction prices, while increasing the incentive rate to up to 50%. However, there are concerns that even without lowering drug prices based on actual transaction prices, a system that encourages ultra-low-price competition will ultimately lead to a steep decline in profits for manufacturers and distributors. Mr. A from a domestic pharmaceutical company expressed concern, “They are essentially fueling price competition. While I understand the intent to create an ecosystem where competition enables cheaper transactions, it will ultimately lead to a resurgence of 1-won and 2-won bids. Everyone will flock to what is effectively legalized rebates, and the manufacturing ecosystem will collapse.” Critics point out that in a situation where small and medium-sized distributors, including CSOs, proliferate and the lack of transparency in distribution channels is a constant issue, a policy solely focused on encouraging price competition will likely cause more harm than good. The same representative added, “Many injectable drugs have already been through 5 rounds of price cuts based on actual transaction prices, with reductions of around 20% each time. If price competition intensifies further, the damage to injectables will be greater. It’s not enough to simply expand incentives; the government must implement safeguards.” Advice was also given that setting an appropriate minimum bid price would be necessary. Another domestic company representative, Mr. B, stated, “It's hard to predict the outcome, but without setting an appropriate minimum bid price, profits will plummet dramatically. At the very least, it should guarantee cost recovery. Considering the relationship between large hospitals and pharmaceutical companies, they might all rush in with a ‘let's all go down together’ attitude.” Mr. B added, "Furthermore, if incentives rise to 50%, even institutions that have been quiet until now may start making more demands. Currently, payments aren't high enough to warrant claiming the maximum price, but if the reimbursement rate hits 50%, that changes. It may essentially turn into a legalized rebate structure." Some have proposed specific restrictions similar to the minimum-price guarantee applied to Essential Exit-Prevention Drugs, arguing that price-protection mechanisms must accompany any incentive expansion. Mr. A added, “It's necessary to put brakes in place. For injectables with high in-hospital usage rates, we could cap prices at 91% of the drug price, similar to exit prevention drugs. Simply trying to intensify low-price competition is armchair theorizing. Once the ecosystem collapses, it's difficult to recover. The government needs to listen more to real-world concerns.”
- Company
- "Trodelvy for TNBC secures evidence for expanded indication"
- by Son, Hyung Min Nov 27, 2025 06:14am
- The therapeutic paradigm for Triple-Negative Breast Cancer (TNBC) is entering a new phase. Gilead's Trodelvy (sacituzumab govitecan), a Trop-2 targeted Antibody-Drug Conjugate (ADC), demonstrated significant results in the Phase 3 ASCENT-03 study, which evaluated the efficacy of this drug as a first-line monotherapy. The study proves Trodelvy's potential to expand beyond its current second-line indication. DailyPharm met with the authors for the ASCENT-03 trial conducted in South Korea, Professor Joohyuk Sohn (Division of Medical Oncology at Yonsei Cancer Center) and Professor Yeon Hee Park (Department of Hematology- Oncology at Samsung Medical Center), to discuss the evolving TNBC treatment landscape and the clinical value of Trodelvy. (from left) Professor Yeon Hee Park of the Department of Hematology- Oncology at Samsung Medical Center , Professor Joohyuk Sohn of the Division of Medical Oncology at Yonsei Cancer Center At the European Society for Medical Oncology (ESMO 2025) Annual Congress held last month in Berlin, the Phase 3 study evaluating Trodelvy's efficacy was unveiled. The trial enrolled patients with unresectable locally advanced or metastatic TNBC who were either PD-L1 negative (CPS below 10) or PD-L1 positive (CPS over 10) but ineligible for immune checkpoint inhibitor therapy. In the trial, Trodelvy recorded a median Progression-Free Survival (PFS) of 9.7 months, which was significantly longer than the 6.9 months with chemotherapy. Furthermore, Trodelvy reduced the risk of disease progression or death by 38% compared to the control group. While Overall Survival (OS) data were not yet mature at the time of the primary analysis, the widening gap in PFS2 (time from randomization to second progression) between the treatment and control groups suggests a potential for future OS improvement. There has been lack of distinct first-line options in untreated metastatic TNBC, besides the immune checkpoint inhibitor 'Keytruda (pembrolizumab)'. Notably, for the PD-L1 negative patient group who are ineligible for pembrolizumab, no viable alternatives to conventional chemotherapy existed. This is why analysis indicates the potential for greater use of Trodelvy. A particularly noteworthy aspect of this study was the design for allowance of crossover from the control group. Control patients whose cancer progressed during the trial were permitted to receive Trodelvy as a salvage chemotherapy. Offering crossover to an agent already proven to improve OS in a subsequent-line setting typically makes it statistically much harder to demonstrate a difference in OS for the primary outcome. Despite this challenge, the investigators chose this patient-centric design, which was evaluated at ESMO as 'a decision reflecting confidence in the drug's efficacy and the study results.' Experts assert that these results reaffirm the clinical value of Trop-2 targeted ADCs, anticipating this will be a pivotal turning point that significantly expands treatment options in the previously limited TNBC space. Q. What was the first-line treatment landscape for TNBC like before the introduction of ADCs? Prof. Park: TNBC is characterized by a lack of traditional targets, and treatment typically stratifies based on PD-L1 expression. In the PD-L1 positive patient group, immune checkpoint inhibitors combined with chemotherapy have shown good results and become the standard of care, leading to PFS improvement, despiting having been less than a year. In contrast, the PD-L1 negative patient group, which comprises the majority (about 60%) has seen virtually no new treatment options for the past 20 years. When clinical trials succeeded for the first time in PD-L1 positive patients, we had patients requesting the combination, but the evidence was lacking for the negative group. Patients with aggressive progression, young age, or recurrence within a year of early-stage adjuvant therapy had to rely on chemotherapy, despite its toxicity. Professor Joohyuk Sohn of the Division of Medical Oncology at Yonsei Cancer CenterProf. Sohn: From an oncologist's view, TNBC is challenging. For nearly 20 years, standard treatment has been limited to conventional chemotherapy agents like taxanes or Xeloda (capecitabine). It is concerning because this cancer has a higher incidence in younger patients, and the restricted options have been a constant source of clinical difficulty. The prognosis for TNBC is notoriously poor. Patients who appear healthy at initial diagnosis can unfortunately pass away in as little as 18 months, a devastating reality. While the introduction of immunotherapies and targeted agents has been helpful, their use is restricted to specific patient groups, underscoring the desperate need for better options. Q. Please elaborate on the key results and significance of the ASCENT-03 study.. Prof. Sohn: PD-L1 This study is highly encouraging because it demonstrated a statistically and clinically meaningful extension of PFS compared with standard-of-care chemotherapy in the first-line treatment of PD-L1-negative TNBC. We anticipate these results will position Trodelvy as a new standard of care in first-line TNBC, offering tangible benefits to many patients. Prof. Park: ASCENT-03 garnered significant attention for presenting the first data in the first-line PD-L1-negative TNBC setting in approximately 20 years. Presenting a new possibility for this patient group makes the results highly meaningful. The primary endpoint of ASCENT-03 was PFS. While the control group, despite utilizing best efforts with existing standard treatments, only achieved 6.9 months, the Trodelvy group reached 9.7 months, which is highly encouraging. Q. What were the unique aspects of the study design? Professor Yeon Hee Park of the Department of Hematology- Oncology at Samsung Medical Center Prof. Park: Several points make this study design stand out. First, the control group included not only single-agent chemotherapies (paclitaxel, albumin-bound paclitaxel) but also combination chemotherapy (gemcitabine-carboplatin). Second, the study registered a significant proportion of patients with a relatively poor prognosis. Trials typically exclude patients who relapse within one year of completing adjuvant therapy. This study, however, included patients who relapsed between 6 and 12 months after adjuvant therapy. Furthermore, some patients had previously received adjuvant immunotherapy. These are patients for whom selecting treatment choices are tough after relapse and metastasis. The most notable feature was the allowance for crossover from the control group. Trodelvy has already demonstrated OS improvement in the subsequent-line setting and is used in clinical practice. It is rare for a new trial to permit crossover to an agent with known survival benefits for ethical and statistical reasons, as it complicates OS analysis and makes it difficult to prove the drug's effect. This was essentially a high-stakes decision, reflecting the research team's confidence in the drug's efficacy. The choice to prioritize the patient perspective by allowing crossover, despite the statistical risk, was highly evaluated. While OS data are incomplete, the study showed a significant effect in the surrogate endpoint, PFS2. Even with the crossover allowance in the control group, the PFS2 was markedly longer in the Trodelvy treatment group. This result clearly demonstrates the critical impact of the initial treatment choice on the patient's overall therapeutic course. The study successfully achieved both meticulous design and uncompromising evidence of efficacy. Q. On the day of presentation of ASCENT-03 data, TROPION-Breast02 data for the competing drug Dato-DXd have also been presented. How do you project the OS outcome for ASCENT-03, given the incomplete data? Prof. Park: ESMO 2025 was a major stage for breast cancer research. Unlike Hormone Receptor-positive or HER2-positive breast cancers, where prognosis has rapidly improved, TNBC has lacked attention. However, this year saw the release of significant data across all three subtypes, with ASCENT-03 and TROPION-Breast02 at the center. There is a strong possibility of an OS improvement with Trodelvy in TNBC. The basis for this is the PFS2 data. Despite the fact that most patients (82%) in the control group who received subsequent therapy crossed over to Trodelvy, the difference in PFS2 between the Trodelvy-treated group and the control group continues to widen. This trend suggests a positive OS outcome is anticipated. A direct comparison between ASCENT-03 and TROPION-Breast02 is challenging due to entirely different trial designs. First, the statistical design and analytical structure differ based on the primary and secondary endpoints. ASCENT-03 set the primary endpoint to PFS alone, while TROPION-Breast02 set it to both PFS and OS. Furthermore, ASCENT-03 allowed crossover to a standard treatment known to improve OS, making the interpretation of the results necessarily more complex. Prof. Sohn: Given the crossover design, there is a possibility that a statistically significant OS difference may not yield even with long-term follow-up. However, since the primary endpoint, PFS, has already been met, there may not be any issues with regulatory approval or clinical use. The fact that Dato-DXd achieved a significant improvement in OS is certainly encouraging. However, direct comparison is difficult due to the design differences. It's also inappropriate to definitively assess superiority or determine which drug is necessary in clinical practice solely on the basis of the presence or absence of OS data. The important part is that both agents met their primary endpoints, diversifying the available first-line treatment options for TNBC. Q. We understand the ASCENT-04 study, evaluating the efficacy and safety of Trodelvy + Keytruda combination therapy, is also underway. Can you share those clinical results? Prof. Sohn: Similar to ASCENT-03, the PFS for patients treated with the Trodelvy + Keytruda combination was statistically significantly longer (11.2 months vs. 7.8 months) than for the chemotherapy + Keytruda combination group. Taken together, these results indicate a high probability that Trodelvy will be established as a new standard of care in the first-line setting, regardless of PD-L1 expression. Prof. Park: This study was also conducted on a large scale. The ability to enroll many patients stemmed from the opportunity for control group patients to access the Keytruda combination therapy, which is not covered by national health insurance. The ASCENT-04 results are also highly encouraging, showing a PFS of nearly 1 year with the Trodelvy + Keytruda combination group. Despite these significant results, the lack of FDA approval at this time is surprising. Q. Q. What is your view on the positive performance of Trop-2 targeted ADCs recently? Prof. Sohn: Oncology research often begins with breast cancer. Breast cancer has the highest incidence among female cancers and carries significant symbolic weight. Furthermore, most research is conducted using cell lines, and breast cancer cell lines have historically constituted the largest proportion. The biological characteristics of breast cancer are well-understood, leading to active clinical trials for new drugs. The high expression rate of Trop-2 in breast cancer makes it particularly responsive to Trop-2-targeted ADCs. While research is ongoing in other cancer types, the response has not been as pronounced as in breast cancer. Prof. Park: The efficacy is due to the high Trop-2 expression in breast cancer, combined with the characteristics of ADCs, where the cytotoxic payload is broadly distributed within the tumor cell and has a sustained effect. Trop-2 serves as the guide that helps direct the payload to the cancer cell. ADCs enhance therapeutic effects by enabling targeted cancer cell killing while retaining the mechanisms and cytotoxicity of traditional chemotherapy. While conventional chemotherapy is highly toxic and difficult to use long-term, ADCs can be regarded as a treatment option that can be used safely and stably for a relatively longer period.
