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- 2025-12-21 20:12:38
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- MET inhibitor Tepmetko enters last stage to reimb in KOR
- by Eo, Yun-Ho Jan 23, 2025 05:54am
- MET-targeted anticancer drug ‘Tepmetko’ has entered the final gateway to insurance reimbursement nearly 3 years after its domestic approval. According to industry sources, Merck Korea has recently started negotiating drug prices with the National Health Insurance Service for its Tepmetko (tepotinib), a treatment for locally advanced or metastatic non-small cell lung cancer with a confirmed MET exon 14 skipping mutation. The drug passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in December last year. Tepmetko obtained domestic approval and went through the reimbursement process in 2021 at the same time as the same mechanism drug Tabrecta (capmatinib). However, no MET cancer drug has been listed for reimbursement in Korea yet. Therefore, it remains to be seen whether Tepmetko will complete the reimbursement process. The drug has failed to meet the criteria for insurance reimbursement twice, including failing review by the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee in March. It then voluntarily suspended the coverage process and submitted another application for coverage in July, and this time, it passed the committee. This achievement was made 3 years after its domestic approval. Non-small cell lung cancer accounts for 80% of all lung cancer diagnoses. MET exon 14 skipping mutation is a rare type of cancer that is present in approximately 3-4% of these patients. In Korea, of the 1,020 NSCLC patients in Korea, 1.9% of the NSCLC patients were confirmed to have MET exon 14 deletion. Tepmetko’s efficacy was demonstrated through the VISION study, which enrolled the largest number of NSCLC patients with MET exon 14 skipping mutations. The results showed a significant life extension effect, with a median progression-free survival (PFS) of 15.3 months and an objective response rate (ORR) of 56.8 percent. The median duration of response (DoR) was 46.4 months, and the median overall survival (OS) was 25.9 months, showing continuous antitumor activity in the long term. Also, according to a presentation by Ji-Youn Han, Professor of Oncology at the Center for Lung Cancer at the National Cancer Center, which was at the Korean Association for Lung Cancer International Conference last year after analyzing 79 Asian patients that participated in the VISION study, the ORR was quite high at 66.7%, and 48.1% in the second-line treatment group. Meanwhile, Tepmetko also showed significant results in a follow-up analysis of Asian patients enrolled in the pivotal Phase III VISION study. In this analysis, Tepmetko demonstrated an objective response rate of 56.6%, a median duration of response of 18.5 months, a median progression-free survival of 13.8 months, and a median overall survival of 25.5 months. The objective response rate was 64.0% in treatment-naïve Asian patients, confirming previous findings that the first dose was more effective. No new safety information was identified, with 39.6% of patients experiencing grade 3 or higher adverse events. In addition, Tepmetko has now passed the Drug Committees (DCs) of more than 30 medical institutions nationwide, including the Big 5 tertiary hospitals - Samsung Medical Center, Seoul National University Hospital, and Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital.
- Company
- "C-Trelin proven effective for SCD treatment…reimb needed"
- by Lee, Seok-Jun Jan 22, 2025 05:55am
- Product photo of There is currently no standard therapy available for 'spinocerebellar degeneration (SCD).' Doctors write prescriptions based on a patient's condition, but there are still unmet needs in 'SCD treatment.' Patients affected by disease likewise. SCD is a degenerative disease affecting the cerebellum or spinal cord due to various underlying causes. Ataxia and dysarthria commonly occur at an early stage, but the disease progression accompanies complications, including dysfunction of the heart, lungs, spine, and bones, causing the risk of death. Other diseases have specific medications; for instance, 'Levodopa' is used for Parkinson's disease and 'aspirin' is used for cerebral thrombosis. However, there is currently no major medication available for SCD. This is because no medication has been proven to improve symptoms or slow down disease progression. The efficacy and safety of C-Trelin Orally Disintegrated Tab (taltirelin hydrate) was demonstrated in large-scale Phase 4 clinical trials in patients with SCD. Dr. Seong Beom Koh, Professor at the Korea University Guro Hospital's Department of Neurology who led the Phase 4 clinical trial, stated, "None of the medications used in patients with SCD are better than C-Trelin Orally Disintegrated Tab." "C-Trelin Orally Disintegrated Tab has proven effective and safe in patients with SCD. Its oral formulation also yields favorable patient compliance. It means that it is a valuable treatment for patients. We should widely use this medication through reimbursement." The efficacy and safety of the drug has been demonstrated in the large-scale Phase 4 trial The clinical trial was published in the Journal of Movement Disorder under the title, 'The Efficacy and Safety of C-Trelin Orally Disintegrated Tab in Patients with ataxia induced by SCD.' The clinical trial involved 160 study participants, including randomly assigned 79 experimental group and 81 control group, and the results showed a significant reduction in the K-SARA (Korean version of Scale for the Assessment and Rating of Ataxia), objective evaluation index for ataxia at 24 weeks treatment, thus confirming the statistical significance of the drug. The standing up and impairment in language entries showed that the average difference in K-SARA of the experimental group was statistically lower than that of the control group. While no suitable medication is available for ataxia in SCD, publication of the Phase 4 trial results in the international journal is significant. Doctors are stating the importance of providing reimbursement for C-Trelin Orally Disintegrated Tab. "C-Trelin Orally Disintegrated Tab is an oral tablet required twice daily. This drug had no significant issue based on the clinical trial evaluating the efficacy and safety. Patient tolerance was favorable, and there were no side effects after administration. To date, no other treatments administered to patients with SCD are said to be efficacious than this drug. Therefore, this drug provides a valuable treatment option for patients with SCD," Dr. Koh remarked. "C-Trelin Orally Disintegrated Tab may require long-term use, which can be costly. This drug should be considered for patients with good mobility and could benefit from it. If a drug is as effective as this, we should pursue active treatment options through reimbursement," Koh added. 'C-Trelin Orally Disintegrated Tab 5 mg' obtained the Ministry of Food and Drug Safety (MFDS) approval in 2015. It costs KRW 4,900 per tablet as a non-reimbursable drug. Two tablets per day cost KRW 9,800 daily and cost KRW 3.5 million yearly. Doctors say that without National Health Insurance reimbursement coverage, it is practically impossible for patients, about 80% of those who do not have jobs, to continue taking the drug that requires long-term administration. Based on these clinical trial results, HLB Pharmaceutical has recently applied for reimbursement again.
- Company
- "Foreign drug price re-evaluation, unfair direct comparison"
- by Kim, Jin-Gu Jan 22, 2025 05:54am
- The Q&A session at the New Year press conference hosted by the KPBMA on January 21. Yunhong Noh, President of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), has criticized the government's re-evaluation of foreign drug price comparison. Noh points out that making a simple drug price comparison poses problem despite differences in socioeconomic circumstances and healthcare systems between South Korea and the countries being compared to. "South Korea faces an important turning point for leaping to the advanced country in the global new drug development field," Noh said. "The government should establish a policy by assessing comprehensive effects on the pharmaceutical and biotech industry." Noh made this statement during the Q&A session at the New Year press conference hosted by the KPBMA on January 21. The government is pursuing a measure to lower domestic drug prices compared to those from 8 countries (U.S., Japan, Germany, U.K., France, Switzerland, Italy, and Canada). The government plans to reference the average adjusted price of six countries, excluding the highest and the lowest, for lowering domestic drug prices. The government and the pharmaceutical industry established a public-private consultative body last year and discussed the specifics of this measure. The previous meeting was held in July 2024, and the government is set to announce the final draft and implement the measure soon. Even after the meeting concluded, the pharmaceutical industry continued criticizing this matter. Despite the upcoming implementation of this system, it is still being criticized. Noh has a similar opinion. "During the ten meetings, I have suggested concerns on this matter," Noh said. "Each country has a different socioeconomic situation. healthcare system, and drug price system with foundation. However, it is worrisome to compare drug prices without considering the difference in the systems." "In advanced pharmaceutical countries, generics are priced high when initially registered, then later lowered due to various mechanisms. However, in South Korea, these drugs are priced low and maintained for a long time," Noh said. "Drug prices differ by time, so it is problematic to compare drug prices at a particular time point superficially." Additionally, Noh suggested to the government to adequately consider the consequences to promote the pharmaceutical industry. "South Korea faces an important turning point for leaping to the advanced country in the global new drug development field," Noh said. "The government should establish a policy by assessing comprehensive effects on the pharmaceutical and biotech industry."
- Company
- Leqembi may be prescribed in general hospitals in Korea
- by Eo, Yun-Ho Jan 22, 2025 05:54am
- The new Alzheimer’s drug Leqembi is landing in general hospitals in Korea According to industry sources, Leqembi (lecanemab) has passed the drug committees (DCs) of top tertiary hospitals in Korea, such as Samsung Medical Center, Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as medical institutions such as Busan Paik Hospital and Gachon Dae Gil Hospital. Since its official launch at the end of last year, the drug has been rapidly expanding its prescription area. Leqembi has been proven to reduce the rate of disease progression and slow cognitive decline by selectively binding to amyloid beta (Aβ) aggregates, which are a known cause of Alzheimer's disease. Due to the lack of treatments for the disease, the desperation of the patients and their families had been indescribable. In addition to public petitions, the MFDS's Korea Orphan & Essential Drug Center has been inundated with inquiries on the date of Leqembi’s approval and supply in Korea. However, the problem is the price of the drug. In the U.S., Leqembi costs about KRW 35 million per year; in Japan, it costs KRW 27 million. Due to its high price, it will take a while for the drug to be approved in Korea and be listed for reimbursement as it requires a tug-of-war between pharmaceutical companies and the government. In the Clarity AD study, Leqembi achieved statistically significant results in both its primary and secondary endpoints. Specifically, Leqembi delayed clinical decline in brain function by 27% at 18 months compared to placebo. While the market for amyloid-targeted therapies such as Leqembi is gaining recognition for its effect in delaying the onset of dementia, the use of the drug has been hampered by its characteristic side effects. The amyloid-related imaging abnormalities (ARIA) that are often mentioned as an issue, are abnormal signals observed on MRI scans, such as brain edema or microhemorrhage that are detected with the drug’s use. Depending on how the adverse event occurs, ARIA is classified as ARIA-E and ARIA-H. ARIA-E can be observed on MRI as brain edema or sulcal effusions, and ARIA-H as microhemorrhage and superficial siderosis. Meanwhile, a special committee composed of 11 members of the Korean Dementia Association recently announced guidelines on using Leqembi that are tailored to Korea’s condition. The guidelines include specific details on ▲ selection of eligible patients for the drug, ▲ necessary tests and preparations before administration, ▲ administration method, ▲ monitoring and response to adverse drug reactions, and ▲ counseling for patients and guardians.
- Company
- HK Inno.N and Roche will co-promote Avastin
- by Chon, Seung-Hyun Jan 22, 2025 05:54am
- Dalwon Kwak, CEO of HK Inno.N.(right), and Ezat Azem, General Manager of Roche Korea (left) HK Inno.N announced on the 21st that it has signed a co-promotion agreement with Roche Korea for Roche’s targeted anticancer drug Avastin (bevacizumab). Avastin is an anticancer drug indicated for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer. Under the agreement, HK. Inno.N will be responsible for marketing and sales of Avastin in colorectal and gynecologic cancers. Roche Korea will conduct sales and marketing of Avastin in areas other than colorectal and gynecologic cancers and conduct research and clinical trials to enhance the clinical value of Avastin. “This partnership is designed to address the unmet medical needs of patients in Korea and bring the clinical benefits of Avastin to more patients,” said the companies. “We are pleased to announce the co-promotion of Avastin following our agreement with Roche Korea to distribute and co-market the influenza treatments Xofluza and Tamiflu,” said Dalwon Kwak, CEO of HK Inno.N. ”The prevalence of colorectal and gynecologic cancers is rapidly increasing due to aging and lifestyle changes, and will work with patients and caregivers to help them overcome their cancers with Avastin.” Continuing innovation for the patients is a top priority for Roche Korea,” said Ezat Azem, General Manager of Roche Korea. “We look forward to leveraging the synergies of this agreement to further contribute to benefiting the lives of more people with cancer.” Avastin has been prescribed to more than 4.2 million cancer patients worldwide in the nearly 20 years since its FDA approval in 2004, treating 340,000 patients annually. In Korea, Avastin was first approved for metastatic colorectal cancer in 2005 and has since expanded to include 7 other cancer types, including non-small cell lung cancer, renal cell carcinoma, epithelial ovarian cancer, cervical cancer, and glioblastoma. When including the combination therapy with Tecentriq, it is indicated for the treatment of 8 cancers.
- Company
- Astellas 'Xtandi' offers high efficacy with low side effects
- by Whang, byung-woo Jan 21, 2025 05:54am
- As more treatment options are covered by reimbursement, concerns about 'how' best to treat prostate cancer are increasing. Given the increasing number of prostate cancer patients increases each year, it is important to discuss which options to provide based on the patient's condition. Dr. Hong Koo Ha, Professor in the Department of Urology at Pusan National University HospitalThe specialist in the field, Dr. Hong Koo Ha, Professor in the Department of Urology at Pusan National University Hospital, emphasizes that there must be discussions about patient-customized treatment. The incidence of prostate cancer is rising among men diagnosed with cancer. The increase in diagnosis is attributed to factors such as aging, westernized dietary habits, and more frequent PSA (Prostate Specific Antigen) testing. "PSA testing was available in the past. However, prostate cancer surgery has increased 5-6-fold," Dr. Ha said. "Increased access to PSA testing due to heightened interest in changed dietary habits and disease has contributed to the increased incidence." Dr. Ha explained. What's different from the past is the variety of available treatment options. Dr. Ha analyzes that prostate cancer treatment options are extensive as new therapies continue to be introduced. "Most patients, when initially diagnosed, fall into the early-stage hormone-responsive prostate cancer where patients respond to hormone therapy. During diagnosis, metastasis affects the later treatment direction. The size of cancer also contributes significantly to prognosis and treatment response. The treatment course differs depending on the patient's condition, even in the mid-stage," Dr. Ha said. Hormone therapies play significant role…Extandi with extended reimbursement, 'positive sign' At the early stage of prostate cancer, surgery is recommended. When cancer progresses, combinations of surgery, radioactive therapy, and hormone therapy are used. And treatment outcomes have been reported to be similar to those received at the early stage. The issue arises when there is metastasis. According to Dr. Ha, a patient's survival period depends on the treatment selection in this case. Currently, when there is metastasis, the most common option is hormone therapy. Hormone therapy advanced after the first generation, and now three types of next-generation hormone therapy have been demonstrated to provide extended survival periods. One of the latest updates is approval of essential reimbursement to the use of Astellas Pharma's Xtandi (enzalutamide) in combination with an androgen deprivation therapy (ADT) for the treatment of hormone-responsive metastatic prostate cancer (HSPC). An expanded role of Extandi has been projected, as the drug can be used regardless of the presence of metastasis (whether in hormone-responsive prostate cancer or following biochemical relapse). Now that a year has passed since the expanded reimbursement, what would be Dr. Ha's opinion be on this? Dr. Ha focused on the effectiveness of Extandi and the low likelihood of side effects. "When outpatient patients with HSPC were treated with Extandi, the results were comparable to those of the ARCHES Phase 3 study, which demonstrated that Extandi significantly reduces disease progression and the death risk, were shown," Dr. Ha said. "As for side effects, Extandi is relatively free of side effects. Therefore, doctors prescribe this drug based on its proven safety and effectiveness." Previously, in the ARCHES Phase 3 study, a 'combination therapy of Extandi+ADT" has been shown to reduce radiographic Progression-Free Survival (rPFS) by 61%. "Extandi can be widely used in almost all patients with prostate cancer regardless of the presence of metastasis, and it is relatively free of side effects than other medications that are similar in administration methods and molecular formulation," Dr. Ha remarked. "As doctors, we are less burdened to explain side effects within the tight time of outpatient consultation." "Regional hospitals pay a crucial role in the treatment of prostate cancer, which requires continuous treatment" Also, Dr. Ha mentioned the role of regional medical centers where patients can continue to receive treatments for prostate cancer, which is diagnosed with increased age and patients have accompanying diseases. "Considering the nature of prostate cancer, we must discuss issues that arise during the continued treatment course. Continuance of treatment at initially diagnosed hospitals has the benefit of quick response when an unexpected issue arises and provides safe care for patients. Regional medical centers play an important role regarding this matter," Dr. Ha said. Dr. Ha recommends patient-customized therapy for the treatment of prostate cancer. Dr. Ha has been conducting collaborative research to develop methods for analyzing patient characteristics and diagnosing using Artificial Intelligence (AI). "Compared to data on prostate cancer surgery from 6-7 years ago, prostate cancer in South Korea had higher malignancy and stages than those in the United States. We are reviewing the proteomics data," Dr. Ha said. "Also, we are collaborating with a Korea-based AI company to use the latest trend AI for research on prostate cancer diagnosis." Additionally, Dr. Ha emphasizes that expanding reimbursement of prostate cancer treatment options and enabling government-funded PSA tests is essential. "Most prostate cancer treatments are costly. If government-funded insurance reimbursement is not applied, it is difficult for doctors to prescribe this medication to patients. We hope that a quick reimbursement process will provide practical and benefits for patients when new prostate cancer is introduced," Dr. Ha remarked. Dr. Ha added, "Cost-effectiveness is important for testing and screening. PSA test costs KRW 10,000 per session and can be done once every 1-2 years, which is relatively inexpensive." He added, "Conducting PSA tests more widely for early diagnosis of prostate cancer, early diagnosis of prostate cancer, can lead to efficient patient treatment and lower costs in the long run, which is projected to become the top cancer among men."
- Company
- Darzalex is granted reimb extension in Korea
- by Moon, sung-ho Jan 21, 2025 05:54am
- Multiple myeloma drug Darzalex (daratumumab) will enter the clinical field next month after successfully expanding its coverage. As new drugs such as bispecific antibody-based therapies are becoming the last treatment option in Korea, Darzalex’s success in expanding coverage has raised the prospect that combination therapy could emerge as the standard of care. # According to industry sources on the 18th, the National Health Insurance Service and Janssen Korea recently completed drug pricing negotiations on the multiple myeloma drug Darzalex for its reimbursement extension. Multiple myeloma is highly resistant and refractory to existing therapies and relapses frequently. Patients who have experienced triple-refractory multiple myeloma - those who have experienced three or more relapses or three or more failures to prior therapies - represent approximately 15% of all multiple myeloma patients and have a median life expectancy of only 5.1 months. Therefore, it is important to treat multiple myeloma with a combination of clinically proven agents from the earliest stage of diagnosis. In the global market, combination therapies that use Darzalex are regarded as the standard of care for the initial treatment of multiple myeloma. “Darzalex is used as a first-line treatment worldwide and is the first monoclonal antibody drug approved for the treatment of multiple myeloma,” said Dr. Chang-Ki Min, Professor of Hematology at St. Mary's Hospital in Seoul. ”Patients who are candidates for newer therapies such as CAR-T cell therapy and bispecific antibody therapy are those who have failed therapies using monoclonal antibodies such as Darzalex, proteasome inhibitors, and immunotherapies.” The DVTd regimen (Darzalex+Bortezomib+Thalidomide+Dexamethasone) is a 4-drug regimen that adds Darzalex to the VTd regimen (Bortezomib+Thalidomide+Dexamethasone). However, in Korea, Darzalex has been used only as a fourth-line monotherapy since it was approved for the treatment of relapsed or refractory multiple myeloma) that has received three prior therapies (fourth or later line). Among them, Janssen Korea has been actively promoting the reimbursement extension of Darzalex since last year and recently agreed to negotiate the drug price with the National Health Insurance Service, which is the final step. Following the conclusion of the drug price negotiations, the Health Insurance Review and Assessment Service has also started revising the anticancer drug reimbursement standards. In other words, HIRA has decided to establish reimbursement standards for DVTd therapy for multiple myeloma patients who have not previously received chemotherapy. HIRA explained that DVTd therapy is “mentioned in many textbooks, and is recommended as category 2A in the NCCN guidelines and as the new standard induction therapy in the ESMO guidelines ([I, A]). However, the ESMO guidelines state that there is no established standard of care for consolidation therapy.” It added, “This regimen consists of 4 cycles (induction) and 2 cycles (consolidation) before and after hematopoietic stem cell transplantation, however, the consolidation therapy is not yet a standard of care in this disease, so the reimbursement standard is set only for the 4 cycles of induction therapy, considering how maintenance therapy is also reimbursed after transplantation, reducing the medical need for consolidation therapy.” With the drug price negotiations settled and the HIRA’s reimbursement notice, it is likely that the reimbursement extension will take effect next month. In the clinic, when the Darzalex-containing DVTd therapy is reimbursed as a first-line therapy, subsequent treatment strategies will also likely be quickly revised. Bispecific antibodies and the CAR-T therapy Kymriah will likely become more prominent as fourth-line options for multiple myeloma. Bispecific antibody-based drugs include Janssen's Tecvayli (teclistamab), Talvey (talquetamab), and Pfizer's Elrexfio (elranatamab). These drugs have been approved and used in the field as the fourth-line therapy option for multiple myeloma in recent years. At the same time, Janssen also has a CAR-T treatment, Carvykti (ciltacabtagene autoleucel), approved in Korea. “Without Darzalex, the application of the latest therapies, such as CAR-T therapies and bispecific antibody drugs, may be delayed,” said a professor of Hematology at a tertiary hospital who requested anonymity. ”According to current standards, patients must first use Darzalex before receiving CAR-T cell therapy. This delays access to effective treatments.” “If Darzalex’s reimbursement is successfully extended, the reimbursement challenges of bispecific antibody drugs will rise as a hot topic this year.”
- Company
- Only half of the multiple myeloma drugs reimb in KOR
- by Eo, Yun-Ho Jan 20, 2025 05:54am
- Despite the increased number of treatment options, patient access to those multiple myeloma drug options has not changed much. Multiple myeloma remains an incurable disease, but in the past, survival rates were very low due to limited treatment options. In recent years, however, innovative treatment options such as monoclonal antibodies, CAR-T therapies, and bispecific antibodies have diversified the treatment options, improving survival. In fact, over the past 20 years, the five-year survival rate for multiple myeloma patients has increased from 29.8% in 2001-2005 to about 50.1% in 2017-2021. However, this is still less than the 60% survival rate found in developed countries such as the United States, and limitation in access to care is regarded as the major contributing factor. Only half of the guideline-recommended drugs are reimbursed in Korea In Korea, only 13 (52%) of the 22 drugs recommended in the NCCN guidelines for multiple myeloma are covered by reimbursement (based on the NCCN guidelines 2024 v2). For example, Darzalex (daratumumab) was approved in 2019 as a first-line combination therapy for multiple myeloma but was only granted reimbursement as a fourth-line monotherapy in Korea. In October last year, 5 years since the Drug Reimbursement Evaluation Committee recognized the appropriateness of expanding Darzalex’s reimbursement coverage under the Risk Sharing Agreement (RSA). Also, Xpovio (selinexor) was granted reimbursement in July 2024, after 4 reimbursement attempts after its approval in 2021. Burden of proving cost-effectiveness for rare cancers such as multiple myeloma One of the reasons why it takes longer to reimburse the crucial multiple myeloma drugs and hinders access is that multiple myeloma is a rare cancer, which renders it more difficult to prove cost-effectiveness than other cancer drugs. In order to apply for reimbursement of high-priced anticancer drugs, the companies must submit data that demonstrates the drug’s cost-effectiveness, as per the guidelines for pharmacoeconomic evaluations. In particular, due to the rising financial expense spent on anticancer drugs in recent years, the government has been setting higher standards for the submitted data to demonstrate the improvement in the effectiveness of new drugs over existing drugs. However, multiple myeloma is similar to rare diseases in that it has a limited number of patients that can enroll in clinical trials, and it is difficult to set a comparator drug. In the case of anticancer and rare disease drugs, clinical trials often have a single-arm design or are limited to Phase II studies, which introduces uncertainties and challenges in the reimbursement review process. Add to this, the number of new treatment options has been growing. Recently, bispecific antibodies, which are regarded as the next-generation biotechnology, have been approved and released for multiple myeloma. Bispecific antibody treatments are immune cell therapies that consist of two monoclonal antibodies that recognize the target antigens of multiple myeloma and T cells. Bispecific IgG2 kappa antibodies, which are composed of two monoclonal antibodies that recognize the target antigens of multiple myeloma, B-cell maturation antigen (BCMA) and CD3 antigen, respectively, are common and are a novel treatment that directly targets cytotoxic T cells to BCMA-expressing multiple myeloma cells. Despite their high clinical efficacy, the bispecific antibody therapies currently approved in Korea, including Pfizer's Elrexfio (elranatamab) and Janssen's Tecvayli (teclistamab) and Talvey (talquetamab), remain non-reimbursed. Suk Jin Kim, Professor of Hematology-Oncology at Samsung Medical Center and the President of the Society of Hematology said, “Although treatment outcomes have improved significantly with the active development of new drugs, the limited access to high-priced anticancer drugs have been preventing patients from receiving optimal treatment as needed.” Kim added, “Policy changes are needed, including flexibility in Korea’s reimbursement standards, to ensure that patients in Korea have access to treatment that meets global standards. We must urgently expand patient access to treatment through early adoption of innovative therapies to close Korea’s survival gap compared with other countries.”
- Company
- Ziihera receives orphan drug designation in Korea
- by Eo, Yun-Ho Jan 20, 2025 05:54am
- The first HER2 bispecific antibody drug Ziihera has received an orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced so through the first orphan drug designation in the new year. Its specific indication is for the treatment of adult patients with previously treated unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer. Ziihera (zanidatamab), a bispecific antibody that targets the HER2 gene, received accelerated approval from the U.S. FDA in November last year after demonstrating efficacy in patients with biliary tract cancer. This is the first time that a bispecific antibody targeting the HER2 gene has been used as a second-line treatment option for patients with biliary tract cancer who are identified as HER2-positive (IHC 3+). Biliary tract cancer is a fatal disease with a poor prognosis and a low five-year survival rate of less than 5% for metastatic disease. The company demonstrated Ziihera’s efficacy through the single-arm phase IIB HERIZON-BTC-01 study. In the trial, the drug met the primary endpoint of confirmed objective response rate (cORR) by independent central review (ICR). The objective response rate was 52%, and the median duration of response (DOR) was 14.9 months. The safety profile of Ziihera was demonstrated in the HERIZON-BTC-01 trial in 80 patients. During the study, 53% of patients treated with Ziihera experienced an adverse event. The most common adverse events were diarrhea, infusion-related reactions, abdominal pain, and fatigue. Serious adverse events occurring in 2% or more of patients were biliary obstruction, biliary infection, sepsis, pneumonia, diarrhea, gastric obstruction, and fatigue. The trial results were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The Lancet Oncology. Long-term follow-up data showing improvement in the duration of response were reported at the 2024 ASCO Annual Meeting. Meanwhile, BeiGene has the domestic rights to Ziihera. The drug is currently being studied in multiple cancers, including Phase III trials in gastroesophageal adenocarcinoma (GEA) and metastatic breast cancer (mBC). It is also currently being studied in the Phase III HERIZON-BTC-302 trial, which compares the combination of Ziihera and standard of care (Soc) to Soc alone in patients with HER2-positive biliary tract cancer.
- Company
- [Reporter' View] Results from J.P. Morgan Conference
- by Lee, Seok-Jun Jan 20, 2025 05:53am
- The Annual J.P. Morgan Healthcare Conference (hereafter J.P. Morgan Conference) has ended. It is the largest funding event in the pharmaceutical and biotech industry and is held in January every year. Many Korean companies have also participated in the event, to the extent that many key R&D people in the Korean pharmaceutical and biotech industry were said to be not present in Korea. According to the J.P. Morgan Conference report, almost 30,000 one-on-one business meetings requested at this year's event were held, where 12,000 agreements have been met. The total market capitalization of 531 companies at the official presentation sessions is US$ 9.6 trillion. Consequently, the J.P. Morgan Conference presents an opportunity for Korean pharmaceutical and biotech companies. According to the J.P. Morgan Conference report, almost 30,000 one-on-one business meetings requested at this year's event were held, where 12,000 agreements have been met. The total market capitalization of 531 companies at the official presentation sessions is US$ 9.6 trillion. Consequently, the J.P. Morgan Conference presents an opportunity for Korean pharmaceutical and biotech companies. Companies referred to as conglomerates in the pharmaceutical industry have unveiled their specific accomplishments. For instance, Yuhan presented its latest data on the new lung cancer drug, Leclaza, through its partner, Johnson & Johnson (J&J). Joaguin Duato, CEO of J&J, said, "A combination therapy of Leclaza and Rybrevant demonstrated results of extending three-year life-expectancy of lung cancer patients over a year. It is a difference that may bring changes to the treatment paradigm." UK-based AstraZeneca's Tagrisso (osimertinib), the standard therapy used in patients with EGFR-mutated non-small cell lung cancer (NSCLC) has the median overall survival (mOS) of approximately 3 years. The combination therapy of Leclaza and Rybrevant is expected to have a mOS of over 4 years. J&J projected the yearly sales goal for Leclaza+Rybrevant to be over KRW 7 trillion. Samsung Biologics announced that it will begin the antibody-drug conjugate (ADC) service in the first quarter of this year. The company aimed to provide top-level Contract Development and Manufacturing Organization (CDMO) services in the ADC field. Moreover, the company announced the building of Plant 6 facility this year. Other companies, including Celltrion, Lotte Biologics, Hugel, and SK Biopharmaceuticals, presented their R&D vision. These companies have shared their success at the J.P. Morgan conference. In contrast, some companies showed a different stance before and after the conference. It is difficult to estimate, but based on yearly trends, more than half of the companies that promoted before the conference did not issue additional press reports afterwards. Despite using promotional keywords, such as promoting technology transports, disclosing growth strategies, conducting big pharma meetings, and establishing facilities, these companies failed to release feedback after attending the J.P. Morgan Conference. The J.P. Morgan Conference has ended. Companies must release their accomplishments following the conference if they genuinely wish to be acknowledged for their company values. Rather than issuing promotional press releases beforehand, they should share objective results afterward. If one issues a promotional subject, providing feedback is essential. Additionally, companies must announce their accomplishments. Disclosable materials are limitless, depending on how companies view them. This week is the best time for companies to showcase their successes at the J.P. Morgan Conference.
