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2026-04-08 16:59:22
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Company
First oHCM drug Camzyos applies for reimb in Korea
by
Eo, Yun-Ho
Jan 22, 2024 05:49am
The first-ever obstructive hypertrophic cardiomyopathy (oHCM) treatment, ‘Camzyos,’ is being reviewed for reimbursement in Korea. According to industry sources, BMS Korea has recently applied for the reimbursement listing of its new obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten). Therefore, whether the drug will be deliberated by the Health Insurance Review and Assessment Service within the first quarter of this year remains to be seen. Camzyos is the first and only cardiac myosin inhibitor that specifically targets excess cross-bridge formation of myosin and actin proteins, the main cause of oHCM. Camzyos can improve left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin and relaxing the over-contracted heart muscle. In the Phase III EXPLORER-HCM trial, which served as the basis for Camzyos’s approval, Camzyos achieved and improved the primary composite endpoint of the proportion of patients with decreased symptom burden (by NYHA class) and functional capacity (peak oxygen consumption, pVO2) by more than two times compared with placebo. In particular, 20% of the patients who received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement. Also, the dynamic left ventricular outflow tract obstruction was reduced by over 4 times with the use of Camzyos. 7 out of 10 patients treated with Camzyos improved to the extent that they would not consider surgery, and showed consistent benefits over 30 weeks. oHCM is a rare disease that occurs when the left ventricular muscle of the heart becomes abnormally thick, obstructing blood flow through the aorta to the rest of the body. Its main symptoms are shortness of breath, dizziness, chest pain, fainting, etc., which appear in various ways and can increase the risk of various cardiovascular complications such as heart failure and atrial fibrillation There had remained a high unmet need for the treatment oHCM as its treatment focused more on symptom relief than fundamental cure. Treatment options such as beta-blockers and non-dihydropyridine calcium channel blockers can reduce the heart rate and myocardial contractility, but it is difficult to expect long-term improvement with these existing drug treatment options alone. Meanwhile, the European Society of Cardiology revised its HCM guidelines for the first time in nine years with the introduction of Camzyos and recommended it as a second-line treatment. Among all treatment options for oHCM, Camzyos received the highest level of evidence, level of evidence A. Previously, no other recommended drug option had a higher level of evidence than B.
Policy
Forxiga withdraws from the Korean mkt despite reimbursement
by
Lee, Tak-Sun
Jan 22, 2024 05:48am
The SGLT-2 inhibitor ‘Forxiga Tab,’ which its company plans to withdraw from the Korean market in the first half of the year, will now be reimbursed for chronic heart failure. However, the withdrawal of the drug from the market has put a damper on the reimbursement expansion. Even if it is reimbursed from next month, there will inevitably be a gap in the use of the treatment when stocks run out due to the discontinuation of its supply. Therefore, patients with heart failure in Korea are at risk of losing access to the treatment option of Forxiga despite the coverage expansion. The Ministry of Health and Welfare announced in a preliminary notice of revisions to the drug reimbursement standards that it will expand reimbursement for SGLT-2 inhibitors such as Forxiga and Jardiance to chronic heart failure from the 1st of next month. With the revision, Forxiga and Jardiance will be reimbursed for patients with chronic heart failure and a left ventricular ejection fraction of 40% or less who are receiving a stable dose of standard therapy. Here, standard therapy is defined as an ACE inhibitor or angiotensin Ⅱ receptor blocker (ARB) or sacubitril-valsartan in combination with a beta-blocker or aldosterone antagonist. Forxiga and Jardiance can also be used in combination with other standard therapies for heart failure. As a result, the treatment scope of Forxiga, which had mainly been used to treat patients with diabetes, was been extended to chronic heart failure. However, the reimbursement extension was overshadowed by the company's withdrawal from the domestic market in the first half of this year. AstraZeneca announced late last year that it would be withdrawing Forxiga from the domestic market in the first half of this year. Given the upcoming domestic supply disruption, patients with heart failure may be hesitant to use Foxiga even with the reimbursement extension. The patients will have to discontinue use of Forxiga the day the remaining stock runs out, On this, AstraZeneca Korea said, "We are in multi-faceted discussions with the health authorities on how to continue treatment for patients with chronic heart failure and chronic kidney disease who are using Forxiga. We currently have secured sufficient quantities for domestic supply for the year.” The problem is, other than Forxigna, none of the same-ingredient generics that have been released since April last year own the chronic heart failure indication. Upon Forxiga’s market withdrawal, generic versions of the same drug would have to be used, but this is difficult because the generic versions are not authorized or reimbursed for the chronic heart failure indication. This is because Forxiga’s patent for chronic heart failure does not expire until March 2040. Due to this, the reimbursement extension granted for SGLT-2 inhibitors is likely to benefit Boehringer Ingelheim Korea's Jardiance. Jardiance has yet to launch a generic, and other SGLT-2 inhibitor generic drugs do not have a chronic heart failure indication. Therefore, whether the health insurance authorities will find a way to maintain the use of dapagliflozin, Forxiga’s main ingredient, available for chronic heart failure, remains to be seen.
Policy
P3T for chin fat reduction injection ‘AYP-101’ approved
by
Lee, Hye-Kyung
Jan 19, 2024 05:45am
A Phase III trial for Amipharm's 'AYP-101', an injectable drug for submental fat reduction, will be conducted in Korea. On the 16th, the Ministry of Food and Drug Safety approved a Phase III clinical trial to ‘evaluate the efficacy and safety of AYP-101 in reducing submental fat in adults with moderate-to-severe convexity or fullness associated with submental fat. Amipharm had previously conducted a Phase II trial for the injection on 96 Koreans from August 2021 to June 2023 and will initiate the Phase III trial in Korea with the MFDS approval. AYP-101 is an injectable for submental fat reduction that selectively induces fat cell apoptosis and lipolysis. Its main ingredient is polyene phosphatidylcholine (PPC), a natural substance extracted from glycine max. merr (soybeans) at high purity. In 2018, Amipharm obtained a patent from the Korean Intellectual Property Office for "Composition and Manufacturing Method of Local Fat Reduction Injectable (AYP-101) without Pain, Edema and Side Effects. If commercialized, Amipharm expects AYP-101 will become the first new incrementally modified drug to be developed in Korea in the aesthetic field. AYP-101’s composition improves the disadvantages of existing PPC injections, which cause pain and swelling through a mechanism of action that brings about cell necrosis. PPC injections have previously been approved for cell membrane binding and regeneration in areas such as liver disease and dementia as ‘Lipobin Inj,’ but have been used off-label as lipolysis injections. Current treatment options for submental fat, also known as a double chin, are limited. Existing methods include off-label, mesotherapy cocktail injections performed under general or local anesthesia and surgical liposuction performed under general anesthesia. AYP-101 is expected to help expand the therapeutic area for the injection to patients who are interested in the non-surgical injectable method of localized fat reduction. Meanwhile, AMI Investment, an investment company established through a 6:4 joint venture between KPM Tech and Telcon, invested KRW 10 billion and acquired 810,000 shares (24.2% stake) of AmiPharm, and became the second largest shareholder. Amipharm holds a patent for 'Composition and Manufacturing Method for Injectable Drug Containing PPC without deoxycholic acid sodium’ that it obtained in Korea in 2014 and a patent for 'Composition and Manufacturing Method for Fat Decomposition Substance that contain PPC' in the United States in 2015.
Policy
Emerging candidate for Dir. of the Pharmaceutical Benefits
by
Lee, Jeong-Hwan
Jan 19, 2024 05:45am
Secretary Jung-min Yu (Left), Director Chang-Hyun Oh (Right). Chang-Hyun Oh (55/College of Pharmacy, Chung-Ang University), the incumbent director of the Pharmaceutical Benefits at the Ministry of Health and Welfare (MOHW), is expected to be succeeded by Jung-min Yu (passed the 51st civil service exam/Ewha Womans University), who is currently serving as Secretary in the Office of the Senior Secretary to the President for Social Policy while being transferred to the Presidential Secretariat. Oh is expected to rejoin the Ministry of Food and Drug Safety (MFDS) after his promotion. According to the sources in the pharmaceutical industry on the 17th, MOHW will make personnel changes for the position of Director of Pharmaceutical Benefits soon. The Division of Pharmaceutical Benefits is responsible for various aspects of domestic pharmaceutical reimbursements. Specifically, its responsibilities include conducting cost-effectiveness evaluations and setting the upper limit of healthcare benefits (insurance drug pricing) for pharmaceuticals seeking reimbursements, reassessing the drug prices of previously listed insured drugs, developing comprehensive plans for post-insurance management of insured drugs, and conducting research and investigations related to the insurance reimbursement system for pharmaceuticals. If Yu assumes the position of the Director of the Pharmaceutical Benefits, she will also oversee the practical implementation of the revised drug pricing system to ensure fair-value compensation for innovative new drugs, which was announced in December of last year, in addition to Yu’s responsibilities related to the division. Secretary Yu initially started her career in the MFDS, then moved to the Office for Governmental Policy Coordination, and later joined the MOHW. Subsequently, Yu was transferred from working as the Director of healthcare security management in May 2022 to take the position as Secretary in the Office of the Senior Secretary to the President for Social Policy and continued to work in that position. Yu has an extensive background in roles within the MOHW, including working in the Division of National Pension Policy, Committee on Low Birthrate, and the Division of Healthcare Policy. After serving as the Head of the Healthcare Delivery System Task Force, Yu was promoted to the position of Director of healthcare security management. In March 2021, while serving as Secretary at the MOHW, Yu was recognized from the Prime Minister for her proactive administration, which included implementing temporary telephone counseling and prescriptions to prevent the spread of Covid-19 outbreak in Korea. Director Oh is expected to rejoin the MFDS after his promotion. Oh, who graduated from Chung-Ang University, is a government official responsible for pharmaceutical matters. He previously transferred to the MOHW from the MFDS through a personnel exchange program.
Policy
Celltrion rebrands and sells self-manufactured drugs
by
Lee, Hye-Kyung
Jan 19, 2024 05:44am
Celltrion Pharm will discontinue importing the original diabetes and hypertension drugs that it has successfully self-manufactured after acquiring all the rights, including sales rights and patents, from Takeda Pharmaceutical. According to the list of supply discontinuation drugs reported to the Ministry of Food and Drug Safety, the soon-to-be-discontinued drugs include Celltrion's diabetes drug ‘Nesina Tab (alogliptin benzoate),’ 12. 5mg and 25mg; ’ as well as ‘Nesina Act Tab (pioglitazone hydrochloride-alogliptin benzoate)’ 25/30mg, 25/15mg; and the hypertension drug ‘Edarbi Tab (azilsartan medoxomil potassium)’ 40mg, 80mg; and Edarbyclor (chlorthalidone-azilsartan medoxomil potassium) 40/25mg. Also, the company will discontinue sales of ‘ActosRyl Tab (glimepiride- pioglitazone hydrochloride)’ 30/4mg and 30/2mg due to deteriorating product profitability from decreased sales volume. In December 2020, Celltrion acquired all rights, including sales and patents, of Takeda Pharmaceutical's 12 ETC drug brands including ‘Edarbi’ and 'Nesina,' as well as 6 OTC drugs such as ‘Whituben Q’ and ‘Albothyl’ in 9 Asia-Pacific countries for USD 278.3 million (approximately KRW 30.74 billion), and has been preparing to self-produce and sell these products to ensure stable product distribution. The diabetes drug Nesina that is being discontinued was rebranded to ‘Celltrion Alogliptin Met’ and Nesina Act to ‘Celltrion Alogliptin Benzoate.’ In addition, the hypertension treatments Edarbi Tab and Edarbyclo Tab were approved as 'Celltrion Azilsartan Medoxomi Tabl' and 'Celltrion Azilsartanclo Tab,’ and have been localized. Celltrion Pharmaceutical said, "We have discontinued imports due to self-production. We will supply our own products to the market before the stock of imported products is exhausted, and we will establish a manufacturing plan according to market needs." In the case of its diabetes drug ActosRyl, the company said that it would terminate its sales due to the decline in sales volume with prescriptions of around 100,000 tablets per year, and because there are many existing single-agent drugs that contain glimepiride and pioglitazone. Meanwhile, the Celltrion Group announced in January that it will separately sell the sales rights to ETCs in all of the Asia-Pacific region excluding Korea, and OTCs in the Asia-Pacific region, that it had acquired from Takeda Pharmaceutical in 2020. The business rights for the ETC in the Asia-Pacific region is about KRW 209.9 billion, and Celltrion Group is expected to make a significant return on the KRW 138 billion investment it had made at the time of acquisition. However, the items that reported discontinuation of original imports due to in-house conversion and self-manufacture were excluded from the sale and will continue to be sold in Korea by Celltrion Pharm. Celltrion Group excluded the Asia-Pacific rights for Nesina, Actos, and Edalbi from the list of products it will sell.
Company
Hemlibra reduces risk of exercise-associated bleeding
by
Lee, Seok-Jun
Jan 19, 2024 05:44am
JW Pharmaceutical’s hemophilia A treatment ‘Hemlibra (emicizumab)’ The research findings, which include data on the physical activities of patients treated with JW Pharmaceutical’s hemophilia A treatment ‘Hemlibra (emicizumab)’ and their safety profile, have been published in the International Journal of Hematology (Int J Hematol). Hemlibra is an innovative new drug that mimics the function of blood coagulation factor VIII, which is usually deficient in patients with hemophilia. It is unique in that it can be used to treat hemophilia A in both patients with antibodies and those who are resistant to existing treatments (factor VIII drugs). A single subcutaneous injection of Hemlibra can yield a lasting preventive effect for up to four weeks. Last May, reimbursement subjects were expanded to patients with non-antibody severe hemophilia A patients aged one or older. According to the company, the research team led by Professor Keiji Nogami from the Department of Pediatrics at Nara Medical University conducted the study, which enrolled 107 patients with non-antibody severe hemophilia A with an average age of 35, from Jan. 2019 to May 2021. The research team evaluated the relationship between patients' physical activity and measurements such as bleeding events and safety using the electronic patient reporting application 'ePRO' and wearable activity trackers following Hemlibra treatments. The research findings showed that, following Hemlibra treatments, 47 out of 74 patients aged six or older engaged in various physical activities over eight days at 5 weeks, 25 weeks, 49 weeks, 73 weeks, and 97 weeks. ePRO recorded 396 physical activities, while wearable activity trackers recorded 329 activities. Based on the data from wearable activity trackers, walking exercise was the most common physical activity among patients, with 24 individuals (32.4%) participating. This was followed by cycling with 11 patients (14.9%) and soccer with 4 patients (5.4%). The range of activities patients engaged in included high-intensity exercises such as basketball, skiing, and tennis, in addition to soccer. In the ePRO data, it was observed that bleeding occurred only twice during the recorded exercise sessions. 106 patients with Hemophilia A reported a mean annualized bleeding rates (ABR) of 0.91. During the study, zero bleeds were reported in 57 patients, making 53.8% of the total. “This research holds significant value as it demonstrates that patients, when treated with Hemlibra, can participate in various physical activities without requiring additional injections of factor VIII drugs before exercise. We hope that Hemlibra will allow more individuals with Hemophilia A to engage in a wide range of physical activities without limitations, “ a representative from JW Pharmaceutical stated.
Opinion
[Reporter’s View] Forxiga withdrawal raises concern
by
Son, Hyung-Min
Jan 19, 2024 05:44am
AstraZeneca, the UK-based global pharmaceutical company, is withdrawing its diabetes treatment Forxiga (ingredient: dapagliflozin) from the Korean market, ten years since its approval in 2013 in Korea. Initially approved as SGLT-2 inhibitor-class diabetes treatment, Forxiga achieved success as its indications were expanded to include conditions like heart failure and kidney disease. Forxiga generated sales of 55 billion won in the previous year. However, AstraZeneca has decided to withdraw Forxiga from the Korean market, giving up annual sales of 50 million won. This decision entails not only the supply halt, but also the withdrawal of approval and reimbursement. What factors have influenced AstraZeneca to make such a decision? The prevailing analysis suggests that reduction in drug pricing was a significant factor in Forxiga’s withdrawal. The primary reason for the withdrawal of Forxiga is widely attributed to the price reduction resulting from the expiration of its patent. AstraZeneca Korea contested the government’s price reduction measure and initiated administrative litigation against them. Having granted suspension of the measure, Forxiga’s current drug price will be maintained through February. However, there is no guarantee that the price of Forxiga will remain at its current level after February. Forxiga’s price could be adjusted to 53.55% of its current price, which is around 730 won, due to patent expiration. Additionally, further reductions in the drug price may be possible due to expanded reimbursement criteria and the price-volume agreement program (PVAP). The drug price of Forxiga in Korea is currently less than 1/30th of the price in the United States. Further price reductions could potentially lead to complications in manufacturing. Furthermore, the cost for conducting clinical trials to expand its indications to include heart failure and kidney disease is substantial. Another factor that may have influenced Forxiga’s withdrawal is that price reductions in Korea can affect drug pricing in neighboring countries. East Asian countries, including China, Japan, Taiwan, and others, may demand drug price reductions referencing the price in Korea. As a global pharmaceutical company, the company needs to consider the potential impact on drug prices beyond Korea. Furthermore, factors such as commission expenses from joint marketing agreements and heightened competition resulting from generic releases may have influenced this decision. The concern is that the current withdrawal of Forxiga could be the beginning of the phenomenon known as ‘Korea Passing’ by global pharmaceutical companies. Entering the Korean market can be challenging for global pharmaceutical companies seeking to establish a presence in East Asia. The reductions in drug pricing and insurance reimbursement policies applied to innovative drugs make the Korean market less attractive to global headquarters. While it's understandable that the government seeks to implement fiscal measures to improve savings in a single national healthcare system like Korea's, global pharmaceutical companies cannot create a 'special drug pricing' exclusively for Korea. Furthermore, Korea employs various methods to reduce drug prices, including reevaluations of reimbursement adequacy, clinical reevaluations, price-volume agreements, and overseas price comparisons. Technology advancement is expected to result in the continuous development of innovative new drugs. Survival rates for diseases that were once life-threatening have improved for patients, and there is hope for recovery in the case of rare and incurable diseases. If these innovative new drugs cannot enter the domestic market in the future, Korean patients may have to seek medical treatment abroad. For patients to access innovative new drugs, there needs to be more communication between the government and pharmaceutical companies. It should not be a unilateral announcement, but an open approach aimed at improving patients’ access to innovative new drugs.
Company
Keytruda's reimb for 6 indications will be reviewed
by
Eo, Yun-Ho
Jan 19, 2024 05:44am
The reimbursement challenge for Keytruda continues this year. Although no results have been made, the company seems to be on a steady course in applying for reimbursement. According to industry sources, 6 indications of MSD Korea’s PD-1 inhibitor immuno-oncology drug Keytruda (pembrolizumab) are expected to be submitted to the Health Insurance Review and Assessment Service's Cancer Disease Review Committee for reimbursement deliberations at the committee’s first meeting this year. Keytruda, which attracted attention in June last year for submitting an application for coverage expansion for 13 indications, has so far received a re-deliberation decision for 7 of the indications - triple-negative breast cancer (TNBC), head and neck cancer, cervical cancer, bladder cancer, esophageal cancer, endometrial cancer, and colorectal cancer. The other 6 remaining indications are expected to be presented for deliberation this time. Specifically, the indications are: ▲ early triple-negative breast cancer; ▲adjuvant therapy after surgery for renal cell carcinoma; ▲advanced endometrial carcinoma; ▲MSI-H or dMMR metastatic small bowel cancer; ▲MSI-H or dMMR metastatic ovarian cancer; and ▲MSI-H or dMMR metastatic pancreatic cancer. As a Risk Sharing Agreement (RSA) drug, each indication must go through an evaluation procedure equivalent to that of a new drug in order to receive reimbursement extensions. Indications approved through Phase III trials must undergo pharmacoeconomic evaluation to prove cost-effectiveness, and indications approved based on Phase II trials must also undergo negotiations to apply for pharmacoeconomic evaluation exemptions. Therefore, whether the discussion on expanding Keytruda's reimbursement to a record number of indications, will produce results at the first CDDC meeting of 2024, remains to be seen. Meanwhile, Keytruda added a new first-line indication for gastric cancer at the end of last year, making it the first new first-line option for gastric cancer approved in 13 years, following ‘Herceptin (trastuzumab)’, which was approved in 2010. The approved gastric cancer indication is Keytruda's 26th indication.
Company
AstraZeneca begins ERP and business unit restructuring
by
Son, Hyung-Min
Jan 18, 2024 04:51pm
AstraZeneca Korea has initiated an early retirement program following the withdrawal of the diabetes treatment Forxiga from the Korean market. The company has stated that it is in discussions with the government to minimize the impact of Forxiga’s withdrawal along with its business unit restructuring. According to the pharmaceutical industry sources on the 18th, AstraZeneca Korea is currently implementing an Early Retirement Plan (ERP). Under this plan, the ERP compensation package is structured as of January 2024, with a monthly base salary*(years of service*2+8) + 130 million won. For example, an employee earning a monthly base salary of 5 million won with 10 years of service would receive an additional 130 million won on top of 5,000,000 multiplied by 28. AstraZeneca Korea’s Forxiga Forxiga (ingredient: dapagliflozin), a SGLT-2 inhibitor class treatment for diabetes, is a blockbuster drug that accumulated sales of 55 billion won in the previous year. However, AstraZeneca Korea announced its withdrawal from the Korean market in December last year. The primary reason for Forxiga's withdrawal is widely attributed to the price reduction resulting from patent expiration. AstraZeneca Korea contested the price reduction resulting from the generic listing and initiated administrative litigation against it. While the court has accepted this for execution suspension, if price reductions are implemented after February, the current price of around 730 won may drop to the 390 won range. However, as Forxiga's indications were expanded to conditions like heart failure and kidney disease, in addition to Type 2 diabetes, continued price reduction remains possible. The challenge for the company is that the price reduction in Korea can influence the price of the drug in neighboring countries, and the company cannot rely solely on sales in Korea. The price of Forxiga in Korea is known to be the lowest among OECD countries, approximately 1/40th of the price in the United States. "A decision to withdraw Forxiga takes into account various factors beyond just price. We are currently in discussions with the Ministry of Food and Drug Safety (MFDS) regarding the withdrawal and timing of domestic withdrawal," a representative from AstraZeneca Korea stated. AstraZeneca Korea to restructure business units while maintaining the sales of combination drugs. AstraZeneca Korea is also undergoing a restructuring of its business units. The current Respiratory & Immunology Business Unit and Cardio Vascular Renal Metabolism (CVRM) Business Unit will be integrated into the BioPharmaceuticals Business Unit. Following the integration, AstraZeneca Korea will operate with three units: BioPharmaceuticals, Oncology, and Rare Disease. However, AstraZeneca Korea clarified that the organizational restructuring is not because of the ERP program. According to a company representative, as part of the headquarters' strategy, existing CVRM and Respiratory & Immunology business units will be integrated into the BioPharmaceuticals Business Unit. And products like Xigduo XR Tab (Dapagliflozin/Metformin) and Sidapvia Tab (Dapagliflozin/ Sitagliptin) will continue to be part of the CVRM Business Unit's roles. For combination drugs, the extent of price reduction is not significantly greater than that of Forxiga, as there are no additional indications other than type 2 diabetes. As a result, the company may have chosen to maintain domestic sales of Xigduo XR and Sidapvia. Beginning this year, HK Inno.N will sell Xigduo XR and Sidapvia in Korea. "We believe that Xigduo XR can provide additional benefits to patients as a combination drug, and the factors taken into account were different from those for Forxiga," a representative from AstraZeneca Korea stated. The concern revolves around patients who are currently taking the active ingredient dapagliflozin and have conditions such as heart failure and kidney disease. Currently, among SGLT-2 inhibitors, only Boehringer Ingelheim's Jardiance has secured indications for heart failure and kidney disease. The withdrawal of Forxiga could potentially create challenges for patients and doctors in accessing the treatment. "The decision to withdraw Forxiga was extremely difficult for the company, considering the potential impact on patients in accessing the treatment," a representative from AstraZeneca Korea stated. "AstraZeneca Korea is actively engaged in discussions with the MOHW to find solutions that would allow patients receiving treatment for chronic heart failure and chronic kidney disease to continue their treatment.” In response to concerns about potential shortages and supply issues with Forxiga at the end of last year, a company representative said that they have secured enough of the drug. "The supply of Forxiga is sufficiently secured for this year,” the representative stated and clarifying, “Even if the approval is withdrawn, insurance code for the drug remains valid for six months, so we have secured the quantity for that duration.”
Company
Keytruda approved as 1st-line treatment for gastric cancer
by
Son, Hyung-Min
Jan 18, 2024 04:46pm
Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center Keytruda, a cancer immunotherapy developed by MSD, has been approved as a first-line treatment for gastric cancer in Korea. Keytruda has emerged as a new first-line treatment option, thirteen years after Herceptin (ingredient: trastuzumab) received approval in 2010. On the 16th, MSD hosted a press conference at Lotte Hotel Seoul commencing expanded indication for Keytruda (pembrolizumab) as a first-line treatment for HER2-positive gastric cancer. In December last year, Keytruda received expanded approval for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for patients diagnosed with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. The approval of Keytruda in Korea brought a significant change in the first-line treatment options, thirteen years after Herceptin (trastuzumab) received approval in 2010. Previously, several treatment options, including lapatinib plus paclitaxel, lapatinib plus chemotherapy, trastuzumab emtansine, and trastuzumab plus pertuzumab plus chemotherapy, were tested in clinical trials for gastric cancer patients, but these treatments did not yield successful outcomes. The Phase 3 KEYNOTE-811 clinical trial, upon which Keytruda’s approval is based, demonstrated efficacy of Keytruda plus trastuzumab plus fluoropyrimidine plus platinum-containing chemotherapy has confirmed efficacy in treating gastric cancer when compared to a therapy of placebo plus trastuzumab plus chemotherapy. The results of the 38.5-month (median value) follow-up of patients with PD-L1 have shown that the Keytruda-combination therapy group acheived a median progression-free survival (PFS) of 10.9 months, which was longer when compared to the 7.3 months PFS observed in the comparison group. The Keytruda-combination therapy recorded an overall response rate (ORR) of 74.4%, which was significantly higher than the 51.9% observed in the comparison group. The Keytruda-combination therapy also demonstrated a complete response (CS) of 11%, whereas comparison group had CR of 3%. Additionally, in terms of interim analysis of overall survival (OS), the Keytruda-combination therapy showed OS of 20.0 months, whereas the comparison group recorded OS of 15.7 months. “HER2 is the only biomarker for gastric cancer,” Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center, noted. Professor Rha also said, “Previously, the rate of PD-L1 expression in HER2-positive patients had not been assessed, but the KEYNOTE-811 clinical study demonstrated that an 85% PD-L1 expression rate in HER2-positive cancer patients.” “The clinical study results demonstrating Keytruda's effectiveness in HER2-positive PD-L1-positive patients represent important data," Professor added. “To provide benefits of cancer immunotherapy, establishing a clinical framework for the dual diagnosis of biomarkers may be necessary.” Given the results indicating a high level of PD-L1 expression in patients with HER2-positive gastric cancer, there is a growing recognition of the importance of establishing a clinical framework for dual diagnosis of biomarkers to ensure that patients can benefit from cancer immunotherapy. Currently, Keytruda is approved for HER2-positive gastric cancer, while Opdivo is approved for HER2-negative gastric cancer. For the application of cancer immunotherapy in the treatment of metastatic gastric cancer patients, HER2-positive patients are mandated to undergo the 22cs assessment, while HER2-negative patients are required to undergo the 28-8 assessment. Hye Seung Lee, Professor in the Department of Pathology at Seoul National University Bundang Hospital Because of this requirement, two separate biomarker assessments may be conducted, beginning with the HER2 assessment, and followed by the PD-L1 assessment. As such, simultaneous assessment of both biomarkers could potentially improve efficiency. “If the two diagnoses were conducted separately, patients might not receive the second assessment due to the additional administrative process,” Hye Seung Lee, Professor in the Department of Pathology at Seoul National University Bundang Hospital, said. “Furthermore, performing a single tissue assessment for dual diagnosis has the advantage of minimizing tissue loss.” Another factor that could hinder patients from receiving a treatment is the time it takes to confirm whether reimbursement is applicable for dual diagnosis. Dual diagnosis falls under the New Health Technology Assessment, which typically takes up to 83 days to make a reimbursement decision after checking whether there is an existing technology for a particular drug. As a result, even if a drug is approved, it takes time for the patients to access the treatment. “Currently, once a drug’s use is approved, it may take more than a month for a patient to receive a dual diagnosis in hospitals, and patient might not receive the benefit of the treatment during the processing time,” Professor Lee explained.
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