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- 2025-12-22 19:40:17
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- Autotelic Bio signs licensing agreement with Chinoin
- by Nho, Byung Chul Jun 12, 2024 05:45am
- (From the left) Fernando Torres Navarrete, BD Director at Chinoin Productos Farmaceuticos in Mexico , Tae-Hun Kim, CEO of Autotelic Bio Autotelic Bio announced on the 7th that it has signed an exclusive license and supply agreement with Chinoin Productos Farmaceuticos in Mexico to distribute ATB-101, a novel combination drug for the treatment of hypertension and diabetes. ATB-101 is a fixed-dose combination product comprising of the hypertension drug ‘olmesartan’ and the oral diabetes drug ‘dapagliflozin.’ It is the world's first combination drug that treats both hypertension and Type 2 diabetes, making it easier for patients with both chronic diseases to take their medication. The company has received Phase III IND approval from the Ministry of Food and Drug Safety for ATB-101 and is currently conducting Phase III clinical trials in patients with essential hypertension and type 2 diabetes at more than 35 major hospitals in Korea, including Seoul National University Bundang Hospital. Autotelic Bio is planning to launch the product globally after proving safety and efficacy through the ongoing Phase 3 clinical trial. For this, the company has registered composition patents in the U.S., Japan, Russia, Mexico, and Brazil, in addition to Korea, and is expanding its patent to other countries such as China. The exclusive license and supply agreement it signed in Mexico is to supply more than 30 million ATB-101 tablets over 5 years. The agreement demonstrates the company's potential to expand into neighboring Latin American countries through Chinosa and is expected to serve as a bridgehead for future global expansion. In addition to the upfront payment, Autotelic Bio will receive additional payments based on development, licensing, and commercialization milestones. Mexico's hypertension and diabetes market is the second largest in Latin America after Brazil and has significant potential. Autotelic Bio plans to grow sales in the Mexican market and reinvest the proceeds in the continued development of innovative new medicines. Chinoin Productos Farmaceuticos is a Mexican pharmaceutical company founded in 1924. It owns a pharmaceutical R&D, manufacturing, licensing, sales, and marketing division, and is regarded to have excellent sales and marketing capabilities, ranking among the top 10 pharmaceutical sellers in Mexico. Autotelic Bio recently completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to advance ATB-101 into the United States. During the meeting, the company received a positive response from the FDA regarding the ongoing Phase III clinical trial, and that an additional local Phase I clinical trial will be sufficient for approval in the U.S. based on the results of the domestic Phase III trial. Based on the results of the pre-IND meeting, the company will be meeting with more than 10 pharmaceutical companies at Bio USA to discuss global rights agreements for ATB-101, including in the US. This year, Autotelic Bio has joined the Boston C&D Incubation Office, a blockbuster global expansion program organized by the Korea Health Industry Development Institute (KHIDI), to strengthen its network for ATB-101’s clinical development and licensing-out activities and create results in the U.S. market. In addition to the incrementally modified drug, Autotelic Bio is developing two other RNA-based anti-cancer drugs, ATB-320 (a dual-mechanism of action anti-cancer RNA drug that works on the TME and inhibits angiogenesis) and ATB-350 (a next-generation KRAS mutation-targeting anti-cancer RNA drug that targets specific tissue). Also, its ATB-610 (ALK5 inhibitor), an inhaler in the company’s anti-fibrosis drug pipeline, has been selected as a project of the National New Drug Development Project in Korea, adding momentum to the company’s development of new drugs.
- Company
- Failed reimb negotiations for Lorviqua, was it for the best?
- by Eo, Yun-Ho Jun 12, 2024 05:45am
- After a long wait, the result was still a ‘no go.’ A solution does exist, but hesitation seems to be holding them back. The insurance reimbursement expansion for the 3rd-generation ALK anticancer drug Lorviqua to first-line therapy has become unclear again. Negotiations between Pfizer Korea and the National Health Insurance Service on the drug price of the ALK-positive NSCLC treatment Lorviqua (lorlatinib), which passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in January and began in March, recently broke down. This is the first time negotiations have broken down for a drug seeking reimbursement expansion risk-sharing agreement (RSA) scheme. The reason for the breakdown is believed to be related to the ‘expenditure cap amount’ rather than 'drug price'. Lorviqua was granted pharmacoeconomic evaluation exemptions when it was first listed. Such PE exemption drugs are required to be reimbursed through the RSA Expenditure Cap Type scheme. As such, a new cap amount would have been derived to account for the increased usage due to the expanded reimbursement during negotiations, and it is likely that Pfizer was unable to accept it. Pfizer's unacceptance may be seen as greed on the pharmaceutical company’s part. However, negotiations are always conducted within a set framework. Pfizer did conduct a pharmacoeconomic evaluation as part of the reimbursement expansion process. So the solution would be to eliminate the disputed expenditure cap requirement and convert Lorviqua to a drug listed through the general process. The other ALK anticancer drugs available in the market - the 1st generation drug ‘Xalkori (crizotinib),’ 2nd generation drug ‘Alecensa (alectinib),’ ‘Zykadia (ceritinib)’ – were all listed through the general track. In fact, Pfizer offered to switch Lorviqua’s reimbursement path to general listing during negotiations, but the government turned it down as it was "unprecedented," and that hesitation led to the breakdown of negotiations. However, patients are left to suffer the damage. It's important to make things work. If necessary, there's no reason not to take the road less traveled. Moving RSA drugs to the general track will also ensure additional price transparency. Pfizer quickly announced plans to reapply for reimbursement expansions. A company spokesperson said: "We are disappointed that final negotiations were unsuccessful. We plan to reapply for first-line reimbursement as soon as possible to ensure patient access to the treatment and we will do our best to engage in effective discussions with the government and facilitate a forward-looking review.” As such, its progress upon reapplication will also be interesting to watch. This was the e first time RSA negotiations have failed. After the unprecedented event, starting the process all over again would be a lengthy process. Regardless of whether reimbursement is expanded or not, the government would need to be flexible in its administration to achieve a quick result. Lorviqua was specifically designed and developed by Pfizer to penetrate the blood-brain barrier (BBB). The drug’s high clinical value as a first-line treatment was recognized in the 5-year long-term follow-up results of the CROWN study that was presented at ASCO. Results showed that Lorviqua reduced the risk of disease progression or death by 81% compared to crizotinib, with 60% of patients surviving without disease progression at 5 years. The risk of brain metastasis progression was reduced in 94% of patients, with only 4 of 114 Lorviqua-treated patients without brain metastases developing brain metastases.
- Company
- Boryung wins the Pomalyst patent challenge for the 2nd time
- by Kim, Jin-Gu Jun 11, 2024 03:25pm
- Boryung has once again challenged the Pomalyst patent and won. Boryung won the second attempt to avoid the substance patent of ‘Pomalyst (pomalidomide),‘ a treatment for multiple myeloma. Despite winning the infringement trial for the same patent in 2021, Boryung had not released generic versions. It seems that Boryung changed the method of generic development and rechallenged the patent. The analysis suggests that Boryung is on a countdown to releasing Pomalyst generic following the second-time success of the patent infringement challenge. It has been confirmed that Boryung has already applied for marketing approval for four doses of pomalidomide. According to pharmaceutical industry sources on June 10th, Boryung received the decision in its favor regarding the claims to confirm the scope of a right for the Pomalyst substance patent. Interestingly, Boryung has already won the previous challenge for the same patent. In July 2020, Boyung filed claims to confirm the scope of a right for the Pomalyst substance patent and won the claim in February. At that time, Kwang Dong Pharmaceutical also challenged the patent and won. However, Kwang Dong Pharmaceutical and Boryung have not released the generic version. Although the patent holder did not appeal the loss of the first trial, neither company released the generics. In three years, Boryung filed a claim with the Intellectual Property Trial and Appeal Board (IPTAB) again. The target for claiming a trial and the type of claim were the same as before. Regarding this, the pharmaceutical industry suggested that both companies attempted to develop Pomalyst generics using a method approved by the IPTAB but faced challenges. Boryung might have developed a generic using a different method. Developing a generic with a new method may have required a new trial decision to confirm whether it does not fall under the scope of the rights of the Pomalyst patent. Consequently, the company may have rechallenged the same patent and won. It has been confirmed that Boryung has already applied for marketing approval for its four doses of generics. The pharmaceutical industry anticipates that Boryung will secure a right to priority of sale for Pomalyst generic exclusively. Celgene’s Pomalyst was approved in 2014 for the treatment of multiple myeloma. According to a pharmaceutical market research firm IQVIA, Pomalyst’s sales reached KRW 22.8 billion last year, up 17% from KRW 19.5 billion in 2022.
- Company
- GC's Sanfilippo syndrome drug receives fast-track status
- by Son, Hyung-Min Jun 11, 2024 05:47am
- GC Biopharma announced on Tuesday that the U.S. FDA has granted Fast Track Designation for GC1130A, a treatment for Sanfilippo syndrome type A (MPS IIIA) that it has been co-developing with Novel Pharma. The fast-track designation follows the FDA's clearance of the Phase I investigational new drug (IND) application for GC1130A last month and is expected to further accelerate the development of GC1130A. Sanfilippo syndrome (type A) is a rare genetic disorder that causes central nervous system damage through the accumulation of heparan sulfate, leading to progressive neurological decline. Without treatment, patients face life-threatening complications by the age of 15. GC1130A is a new biological drug that is being developed using GC Biopharma’s high-concentration protein formulation technology, designed for administration to the central nervous system. It is delivered directly into the brain's ventricles through intracerebroventricular (ICV) injection, a method first applied globally by GC Biopharma's Hunter syndrome treatment, 'Hunterase', which has received marketing authorization in Japan. The potential of GC1130A to meet the unmet medical needs of Sanfilippo syndrome has been recognized by major drug regulatory agencies; in 2023, the FDA granted GC1130A Rare Pediatric Disease Designation (RPDD) and Orphan Drug Disease (ODD), and earlier this year, the European Medicines Agency (EMA) also granted GC1130A ODD status. Currently, GC Biopharma and Novel Pharma are preparing to initiate a multinational clinical trial to evaluate the safety and tolerability of GC1130A in Korea, the US, and Japan. A GC Biopharma official said, “With no approved treatment available for Sanfilippo syndrome, we are pleased that the FDA has granted GC1130A Fast Track designation. This designation will allow us to accelerate the development of our drug to bring hope to patients suffering from Sanfilippo syndrome.” The FDA's Fast Track program is designed to expedite the development and review of drugs intended to treat serious or unmet medical needs. The Fast Track designation provides extensive support, including frequent meetings with the FDA throughout the drug development, clinical, and approval stages.
- Company
- 'Novel drugs·CDMO competitiveness↑'
- by Son, Hyung-Min Jun 10, 2024 05:41am
- Major biotech companies in Korea participated in the BIO International Convention (BIO USA 2024) and introduced their in-house competitiveness. Over 50 Korea-based companies attended the BIO USA 2024, held between June 3-6 in San Diego, United States. They sought opportunities to expand partnerships along with discussions for technology transport. Samsung Biologics showcased its new platform, showing a strong directive to expand the company’s growth related to intensified cell-culture with improved manufacturing capacity. Lotte Biologics, ST Pharm, and Prestige Biologic introduced their contract development and manufacturing organization (CDMO) capacities and held partnering meetings for contract orders. Korean companies have made significant achievements in novel drug development. VaxCell Biotherapeutics showcased positive results of its novel candidate under a phase 2 clinical trial for hepatocellular carcinoma. Genome & Company won a technology transport contract for its antibody-drug conjugate (ADC), confirming its competitiveness. China absent from the BIO USA…all eyes on K-bio According to industry sources on June 9th, 47 Korean companies ran booths during the BIO USA, which was 6 more companies than last year. BIO USA is the world’s largest biopharmaceutical convention, with more than 20,000 leaders in the biopharmaceutical industry participating. Continuing from last year, Korean CDMO companies have gathered attention this year. Notably, due to the introduction of the Biosecure Act by the United States, all eyes were drawn to the Korean companies in the absence of WuXi Biologics, China’s largest CDMO. The United States aims to limit the business with the Chinese biotech companies. Therefore, the analysis suggests that along with Swiss-based Lonza and Japan-based Fujifilm, Korean CDMO companies will have more opportunities. The Korea booth at the BIO International Convention (BIO USA 2024) (photo=KoreaBio). Samsung Biologics launched a new CDO platform called S-Tensify, bolstering CDO competitiveness. S-Tensify supports high-intensity biomedicine development with the latest cell-culture technology. The company shared that S-Tensify’s adoption of N-1 perfusion technology has increased its cell-culture concentration by 30-fold, significantly boosting manufacturing capacity during inoculation at the seed stage (N-1). ST Pharm has started CDMO of CRISPR/Casx, used in gene editing technology. Gene editing is a biomolecular tool for editing precise locations within DNA using zinc finger nucleases, TALEN, or CRISPR/Cas9. CRISPR/Casx is an innovative technology for precisely editing DNA sequences, enabling deletion, addition, or correction of genetic material. Novel drug development using gene editing is currently underway. The U.S. FDA approved exa-cel (U.K.-authorized product name: Casgevy), a CRISPR/Cas9 gene-edited therapy developed by the United States biotech company Vertex Pharmaceuticals and SWISS-based CRISPR Therapeutics. ST Pharm showcased its manufacturing process of sgRNA, which precisely targets the genome. More than 100 mer high-purity sgRNA production is needed to develop medicines, and this manufacturing technology is more difficult than ASO or siRNA oligonucleotides ingredients. During the event, Prestige Biologics shared new CDMO business opportunities due to the imminent passing of the Biosecure Act by the United States. According to the company, over 30 companies have requested meetings, and 6 offers have been received. Prestige Biologics emphasized that the company is equipped with cost competitiveness and quality for a single-use approach. K-bio showcased novel drug development competitiveness In addition to CDMO orders, Korean biopharmaceutical companies also showcased their capabilities in the development of novel drugs. VaxCell Biotherapeutics presented the outcomes of Phase 2a ‘Vax-NK/HCC’ clinical trials for hepatocellular carcinoma. This trial evaluated the efficacy of Vax-NK/HCC plus HAIC combination therapy involving 16 patients with advanced hepatocellular carcinoma who did not respond to conventional treatments. The clinical results demonstrated that Vax-NK/HCC plus HAIC combination therapy had an objective response rate (ORR) of 68.8% and a progression-free survival (PFS) of 16.8 months. Genome & Company has confirmed the competitiveness of its ADC candidate. Earlier this month, the company signed a technology transfer contract with Swiss-based Debiopharm for its ADC candidate, GENA-111. Including the upfront payment of approximately KRW 6.9 billion, the contract size amounts to a maximum of KRW 586.4 billion. GENA-11 is an ADC candidate with a novel mechanism for targeting CD239. CD239 is known to be highly expressed in cancer cells than in healthy cells, and no ADC has been commercialized for targeting this. Genome & Company is considering targeting GENA-111 to treat gynecologic cancer. After assessing which payload would be more effective, the company stated that the final target indication would be decided. Bridge Biotherapeutics shared directives for developing novel drug candidates to treat idiopathic pulmonary fibrosis (IPF). BBT-887 is an innovative new candidate under development in a phase 2 trial. It is a selective inhibitor of autotaxine enzyme. Autotaxine is a protein known to bind to receptors in cells and induce various physiological activities, such as sclerosis and tumorigenesis. Bridge Biotherapeutics presentation (photo=Bridge Biotherapeutics). Last month, Bridge Biotherapeutics received authorization from the Independent Data Monitoring Committee (IDMC) to continue the clinical trial. After evaluating the efficacy and safety data of 75 clinical subjects, there were no concerns related to the drug safety or effects.
- Company
- Chronic kidney disease drug ‘Kerendia’ can be prescribed
- by Eo, Yun-Ho Jun 10, 2024 05:41am
- Bayer’s new chronic kidney disease drug ‘Kerendia.’ ‘Kerendia,’ a treatment for chronic kidney disease, is now available for prescription after receiving approval for insurance reimbursement. According to industry sources, Bayer’s Kerendia (finerenone) has passed the drug committee (DC) of Big 5 tertiary general hospitals, including Seoul National University, Seoul Asan Hospital, and Sinchon Severance Hospital. Additionally, 49 hospitals in Korea have assigned Kerendia’s prescription code. Kerendia is a treatment for chronic kidney disease accompanying type 2 diabetes. It has been listed for reimbursement since February last year. With Chon Kun Dang becoming a marketing partner in South Korea, rapid landing and promotional activities are underway. Kerendia received approval in Korea last year. It is indicated for the treatment to reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate, eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. CKD is one of the most common complications in type 2 diabetes and is an independent risk factor of cardiovascular diseases. While CKD is a progressive disease, it can be difficult to detect because the disease can progress without showing obvious signs until just before the late-stage renal failure occurs. With late-stage renal failure, patients require dialysis or kidney transplants to sustain life. This can pose a socio-economic burden and have a profound impact on a patient’s quality of life. For patients with type 2 diabetes, frequent monitoring and assessment of kidney damage and kidney function are essential. Early detection and appropriate treatment are critical to slowing down the progression of the disease and reducing the risk of cardiovascular diseases. In type 2 diabetes, the three key factors causing kidney disease are hemodynamic changes, metabolic abnormalities, and inflammation or fibrosis. However, in current therapy, treatments targeting hemodynamic and metabolic factors are only available, while treatments targeting inflammation and fibrosis are lacking, highlighting the need for new treatment approaches. Kerendia is a novel therapeutic approach targeting inflammation and fibrosis in adult chronic kidney disease patients with type 2 diabetes. It is the first non-steroidal, selective mineralocorticoid receptor antagonist. Overactivation of the mineralocorticoid receptor (MR) can lead to inflammation and fibrosis, which can result in permanent damages to kidney. Kerendia inhibits the overactivation of the mineralocorticoid receptor, reducing inflammation and fibrosis, and thereby preventing kidney damage. Kerendia demonstrated its effectiveness in the Phase 3 FIDELIO-DKD trials. FIDELIO-DKD trials enrolled approximately 5,700 patients from 48 countries globally, and Kerendia is indicated to inhibit the progression of chronic kidney disease and reduce the risk of cardiovascular events in adult patients with chronic kidney disease accompanying type 2 diabetes. Patients participating in the study received either Kerendia at doses of 10mg or 20mg in addition to standard therapy or a placebo. Clinical outcomes demonstrated that primary composite endpoint consisted of end-stage kidney disease, a sustained decline of more than 40% in eGFR, reduction by approximately 18% compared to the placebo in renal death. In addition, it reduced the secondary endpoints consisting of cardiovascular death, nonfatal myocardial infarction, stroke, or heart failure leading to hospitalization by approximately 14%. The outcomes of major adverse events or the rate of adverse events related to acute kidney damage were comparable between the two groups. Meanwhile, the European Society of Cardiology (ESC) revised its ‘2021 ESC Guidelines for the Diagnosis and Treatment of Acute or Chronic Heart Failure’ and listed Kerendia as a Class 1A recommendation to prevent hospitalization due to heart failure in patients with chronic kidney disease accompanying type 2 diabetes. Additionally, the ESC recommended annual assessment of eGFR and urinary albumin levels to screen for the development of chronic kidney disease in patients with diabetes.
- Company
- Pharma company MRs illegally work for CSOs on the sideline
- by Lee, Seok-Jun Jun 10, 2024 05:41am
- Contract Sales Organizations (CSOs) are trending in the pharmaceutical industry. In the case of small and medium-sized pharmaceutical companies, the companies have been opting to use CSOs rather than their own sales departments, to the extent that their departments are disappearing with the expansion of CSO business. The smaller the company, the more it relies on CSOs. A growing number of companies are outsourcing 100% of their sales. Large companies are also dabbling with CSOs. In 2019, the Ministry of Health and Welfare reported that 45% of the 195 pharmaceutical companies surveyed used CSOs. However, the industry consensus is that the rate would exceed 70% if the pool is narrowed to small and medium-sized companies. With CSOs becoming more mainstream, acts of misconduct are also increasing. One representative example is the act of pharmaceutical company medical representatives (MRs) illegally working for CSOs. According to the industry, many MRs who work for one company are selling their competitors' products at the same time. It's not uncommon to see MRs actively selling their competitors' products that pay higher commissions than their own. The problem is exacerbated by the industry's implicit acceptance of such illegal behavior. There are numerous posts on online job information sites recommending MRs to work for CSOs on the sideline, guaranteeing absolute confidentiality. There are even rumors that some small and medium-sized pharmaceutical companies that are in urgent need of making sales may tacitly allow employees to work for CSOs as long as they meet their sales targets. The CSOs are also encouraging the multicareer path. In fact, one CSO said, "The company can only see the wage and salary income it paid to each employee, so even if the employee earns additional income and reports it to the National Tax Service, the company will never know because it is categorized as business income. We provide full personal protection, so you don't have to worry about getting caught working a second job." Another CSO said, "We guarantee the highest commission in the industry. We work directly with pharmaceutical companies, so we can get the highest commissions. Our CSO is not like the others that are actually a bunch of corporate entities. No one knows how many steps the electronic data interchange (EDI) goes through in those companies, and whether there are any problematic entities, so it's really important to use a CSO that directly deals with the pharmaceutical company." The practice of pharmaceutical MRs doubling as CSOs needs to be abolished, as it can lead to a lack of collegiality and professional ethics, and can cause serious damage to the company in the form of trade secret theft and unfair competition. The industry is also aware of this problem and is making efforts to eradicate the practice. Companies are increasing penalties for MRs who are illegally working two jobs and expanding education and monitoring to prevent such acts. The CSO Reporting System is one of the most notable industry efforts. The CSO Reporting System is one of the key components of the amendments to the Pharmaceutical Affairs Act, which will come into full effect on October 19th. At its core, the bill requires "CSOs to report their business activities to local governments where they are located.” Violators will be punished by imprisonment for up to 3 years or a fine of up to KRW 30 million. Pharmaceutical companies will also be required to check their ability to prepare, keep, submit, and disclose expenditure reports, manage the appropriateness and transparency of their accounting, and be obligated to provide training to prevent illegal acts. The government believes that the introduction of the reporting system will be able to address the illegal practices by CSOs and pharmaceutical companies that circumvent the system, which has been raised as a possible source of illegal rebates. "At a time when the pharmaceutical industry as a whole is making efforts to integrate CSOs into the system, by disclosing expenditure reports and implementing the CSO reporting system, it is imperative that we eradicate and prevent illegal CSO business activities to restore the CSOs’ credibility in the domestic pharmaceutical industry.” Meanwhile, the general business structure of CSOs is as follows. The CSO is referred to as a "corporate CSO," and its employees are referred to as "dealers.” Dealers are usually sole proprietors who work for the corporate CSO, and the corporate CSOs work like middlemen, signing contracts with pharmaceutical companies and setting commissions that they later pay out to their dealers. The corporate CSOs recruit dealers, sign contracts with pharmaceutical companies, receive commissions for sales and redistribute them back to individual dealers.
- Company
- Immuno-oncology drugs demonstrate additional benefit at ASCO
- by Son, Hyung-Min Jun 07, 2024 05:50am
- Global pharmaceutical companies have demonstrated their immuno-oncology drugs’ effect in refractory solid tumors. Clinical results from major immuno-oncology drugs, including Imfinzi, Opdivo, and Yervoy, were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which kicked off last month in Chicago, U.S. In the case of Imfinzi, the trial confirmed a survival benefit in small cell lung cancer. Imfinzi has shown promise in gastrointestinal cancers, including biliary tract and liver cancer. Such results paved the way for the company to add new indications. The combination of Opdivo and Yervoy improved survival in the first-line treatment of liver cancer. The combination has demonstrated efficacy against Nexavar and Lenvima in the first-line treatment of liver cancer, setting the stage for new competition. Imfinzi improves OS, PFS in small-cell lung cancer AstraZeneca's Imfinzi showed efficacy in small-cell lung cancer, an area with a high unmet need. The Phase III ADRIATIC trial evaluated the efficacy of Imfinzi monotherapy and the Imfinzi+Imjudo combination versus placebo in 730 patients with limited-stage small-cell lung cancer whose disease had not progressed after concurrent chemoradiation therapy (cCRT). ADRIATIC study design, which evaluated the efficacy of immuno-oncology drug Imfinzi (Source: ASCO 2024 lecture capture). Patients were randomized to receive a fixed dose of 1,500 mg of Imfinzi every 4 weeks alone or in combination with 75 mg of Imjudo, followed by Imfinzi every 4 weeks for up to 24 months. The primary endpoints were Imfinzi monotherapy’s progression-free survival (PFS) and overall survival (OS) vs placebo. Results showed that Imfinzi monotherapy reduced the risk of death by 27% compared with placebo. Median estimated OS was 55.9 months in the Imfinzi arm compared with 33.4 months in the placebo arm. Approximately 57% of patients in the Imfinzi arm were alive at 3 years, compared with 48% in the placebo arm, and Imfinzi therapy reduced the risk of disease progression or death by 24% compared with placebo. Median progression-free survival (mPFS) at 2 years was 16.6 months in the Imfinzi arm and 9.2 months in the placebo arm, with 46% of patients in the Imfinzi arm experiencing no disease progression at 2 years compared with 34% in the placebo arm. In addition to the small number of patients, small-cell lung cancer has a significantly lower number of treatments available than other cancers. According to a fact sheet published by the Korean Association for Lung Cancer (KALC) and the Korean Central Cancer Registry (KCCR) based on 2015 data, only about 13% of all lung cancer patients (2,658) were diagnosed with small cell lung cancer. As the first immuno-oncology drug to demonstrate efficacy in limited-stage small-cell lung cancer, whether Imfinzi can rise to become a new treatment option in the field is gaining attention. Opdivo+Yervoy improves survival as first-line treatment in liver cancer BMS announced results from the Phase III CheckMate-9DW trial, which evaluated the efficacy of the combination of Opdivo, a PD-1-targeted immuno-oncology drug, in combination with Yervoy, a CTLA-4-targeted immuno-oncology drug. Opdivo and Yervoy demonstrated an effect as first-line treatment in liver cancer (Source: ASCO 2024 lecture capture. BMS is exploring the possibility of securing multiple indications with the Yervoy plus Opdivo combination. The company is currently exploring the potential of the combination in liver cancer, metastatic colorectal cancer, squamous cell carcinoma, and head and neck cancer. The results presented at the 2024 ASCO Annual Meeting are from an interim analysis of the trial that evaluated the efficacy and safety of the combination as a first-line treatment for liver cancer. The trial enrolled 668 treatment-naive adults with unresectable hepatocellular carcinoma who were randomized to receive the Opdivo+Yovoy combination and either Lenvima or Nexavar. Results showed a median OS of 23.7 months in the Opdivo+Yervoy combination arm, compared with the 20.6 months in the control arm. The objective response rate (ORR) was 36% with the Opdivo+Yervoy compared with 13% in the control arm. The median duration of response was 30.4 months for the Opdivo+Yovoy combination arm compared with 12.9 months for the control arm. These results lay the foundation for the Opdivo+Yovoy combination to become a significant competitor in the first-line liver cancer treatment market. Currently, the combinations Tecentriq (immuno-oncology drug) plus Avastin (targeted therapy) by Roche and Imfinzi (immuno-oncology drug)+Imjudo (targeted therapy) by AstraZeneca are available as first-line treatment for liver cancer. In the field, HLB's targeted anti-cancer drug rivoceranib in combination with Hangseo Pharmaceutical's immuno-oncology drug camrelizumab has also recently presented data showing improved survival.
- Company
- "Breast cancer treatments received positive reviews"
- by Son, Hyung-Min Jun 07, 2024 05:50am
- Major antibody-drug conjugates (ADC) have secured positive clinical results in treating breast cancer. ADCs under development by global pharmaceutical companies have shown to be effective in various types of breast cancer, including triple-negative breast cancer, hormone-positive (HR+)/HER2-negative breast cancer. With these results, latecomers have established a foundation to secure indications for breast cancer, following the cases of Kadcyla, Enhertu, and Trodelvy. According to industry sources on June 4th, clinical achievements of several ADCs, including Padcev, datopotamab deruxtecan, and sacituzumab tirumotecan, were presented at the American Society of Clinical Oncology (ASCO 2024) annual meeting, which started on May 31st. Astellas and Seagen have presented clinical outcomes of their ADC Padcev. Padcev, an ADC anticancer agent targeting the cell surface protein nectin-4, has been approved worldwide for urothelial carcinoma. During this meeting, the results of the phase 2 EV-202 clinical study, confirming its potential in breast cancer, were disclosed. Both companies are exploring possibilities not only in urothelial carcinoma but also in breast cancer, gastric cancer, and non-small cell lung cancer, as nectin-4 protein is expressed in various solid tumors. On June 2, the Phase 2 study results of Padcev, a nectin-4-targeting ADC, were presented at ASCO 2024 (source: snapshot of ASCO 2024 lecture presentation). EV-202 clinical study evaluated Padcev’s effectiveness and safety in patients with triple-negative breast cancer and hormone (HR) positive·HER2-negative breast cancer who have been treated with chemotherapy before. The primary endpoint was objective response rate (ORR), and the secondary endpoints were duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and and safety/drug tolerance. The clinical results showed that the Padcev treatment group had an ORR of 19.0% for triple-negative breast cancer, while the DRR, an index measuring the percentage of patients with no disease progression during or after the treatment, was 57.1%. Such results were consistent with the outcomes for HR+/HER2- breast cancer. The Padcev treatment group recorded an ORR of 15.6%, while the DCR was 51.1%. The treatment-related adverse events (TRAE) of over Grade 3 for Padcev were decreased neutrophil counts (7%), decreased white blood cell counts (5%), and increased aspartate aminotransferase (5%). Adverse reactions identified in two cohorts were manageable and consistent with previously disclosed safety data. Currently, for triple-negative breast cancer, there is no ADC approved after Trodevly. All eyes are on whether Padcev would secure an indication for treating triple-negative breast cancer through follow-up clinical results. A TROP2-targeting ADC demonstrated additional effects on breast cancer On June 2, the clinical results of datopotamab deruxtecan, under development by Daiichi Sankyo and AstraZeneca, and MSD’s sacituzumab tirumotecan were disclosed. These two drugs are ADCs targeting TROP2 protein, an intracellular calcium signal transducer regulating cell proliferation and survival. TROP2 protein is expressed in healthy cells but commonly overexpressed in cancer cells. The protein is also associated with drug resistance. Gilead Sciences’ Trodelvy is the only available drug with a similar mechanism that succeeded in commercialization. Datopotamab is under clinical trials to confirm its potential for breast cancer and non-small cell lung cancer. The TROPION-BREAST01 study showed that datopotamab improved PFS for HR+/HER2- breast cancer. This time, the report detailing the study’s patient reported outcome (PRO) was disclosed. The TROPION-BREAST01 study increased the likelihood of datopotamab securing an indication to treat breast cancer (source: snapshot of ASCO 2024 lecture presentation). The clinical study involved 732 patients with inoperable or metastatic HR+/HER2- breast cancer previously treated with at least one chemotherapy. The patients were randomly assigned to either the datopotamab group or investigator’s choice of chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) with a 1:1 allocation. The PRO included (GGS), quality of life (QoL), and time to deterioration (TTD) evaluated by EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The clinical results showed that the TTD for QOL in the datopotamab group was 3.4 months, compared to 2.1 months in the chemotherapy group. TTD for the datopotamab group was confirmed to be delayed in terms of physical function, pain, and most other symptoms and functioning scales. MSD’s sacituzumab tirumotecan was shown to be effective in triple-negative breast cancer. In 2022, MSD licensed the ADC candidate sacituzumab from China-based Sichuan Kelun-Biotech. Results from the phase 3 OptiTROP-Breast01 study compared sacituzumab to investigator’s choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in patients with locally recurrent or metastatic breast cancer. The primary endpoint was PFS, assessed by blinded independent central review (BICR). Interim analysis results for PFS showed that the sacituzumab group recorded a PFS of 5.7 months, which was longer than the 2.3 months in the chemotherapy group. PFS at 6 months was 43.4% for the sacituzumab group and 11.1% for the chemotherapy group. Sacituzumab reduced the disease progression and mortality risk by 69%. OS was significantly favorable for Sacituzumab treatment. “Sacituzumab monotherapy demonstrated clinically meaningful PFS and OS benefits compared to chemotherapies,” an investigator stated. “Moreover, it demonstrated a manageable safety profile for treating triple-negative breast cancer, which has limited treatment options.”
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- ‘Fully utilize the various IBD treatment options available'
- by Eo, Yun-Ho Jun 07, 2024 05:50am
- Professor Hong Sub Lee. Busan Paik Hospital, Inje university. Incidence of Inflammatory bowel disease (IBD), which had been regarded as a condition typically associated with Westerners, is now rising amongst Asian populations as well, including Koreans. According to the IBD fact sheet published by the Korean Association for the Study of Intestinal Diseases, the number of patients with ulcerative colitis and Crohn's disease has more than doubled in 10 years, to 37,000 and 18,000, respectively, by 2019. At the same time, treatments that can be used as a "weapon" by doctors are being introduced competitively to the market are being launched competitively. In an interview with Dailypharm, Professor Hong Sub Lee (Department of Gastroenterology) of Busan Paik Hospital, Inje University, assessed the importance of 'sequencing' the existing and new drugs and preparing an IBD treatment strategy customized for each patient. In recent years, appropriate drug selection has emerged as a key issue in the treatment of IBD in clinical practice in Korea, as treatment options have diversified to include Janus kinase (JAK) inhibitors in addition to conventional biologics. While it is not always possible to immediately switch to another drug when the therapeutic effect of a drug is inadequate, the availability of several prescribable options has created a dilemma of which drugs to use and in what order. Professor Lee explained, "We divide patients into low-risk and high-risk groups according to the presence and severity of symptoms, and then develop a treatment strategy and select drugs accordingly.” Lee added, "High-risk patients are those who are younger, have lesions that invade the entire large intestine and have deep ulcers. They are considered high-risk patients according to IBD metrics, in which case they are judged to be candidates for biologics or small molecule drugs that have recently been introduced in Korea." "We approach patients with fewer symptoms with the usual treatment strategy. But high-risk patients need to start a treatment sequence in line with the health insurance reimbursement system as quickly as possible." Adding to the dilemma for clinicians is the recent increase in the use of JAK inhibitors as a mainstream treatment option for ulcerative colitis and Crohn's disease. "Recently, JAK inhibitors have also been increasingly used to treat IBD. For example, filgotinib is the only JAK inhibitor that can be prescribed directly after azathioprine. According to clinical trials, upadacitinib has shown a high effect. However, to prescribe other JAK inhibitors, you need to first take patients off azathioprine, which is problematic for doctors because they have to remove a drug that they believe is effective for their patients." Therefore, Professor Lee believes that Korea’s reimbursement standards need to be improved to allow for more freedom of choice in clinical practice. "I would like to be able to quickly prescribe the increasing number of drug options to patients who really need them. We don't need to wield a big knife for patients with mild symptoms, but we need to improve the reimbursement standards so that we can approach each patient especially those at high risk with a personalized treatment strategy so that we can actively use necessary drugs.” "In addition to drugs, fecal microbiota transplantation (FMT), which utilizes the gut microbiome to treat IBD, is a major therapeutic option. I opened an inflammatory bowel disease clinic last November and am looking to start a gut microbiota transplantation company and pursue its research. I want to research and develop therapies using FMT to help treat IBD in practice."
