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- 2026-04-07 13:28:20
- Company
- ‘Hemlibra is the most advanced hemophilia A drug availble'
- by Nho, Byung Chul Jun 05, 2024 05:47am
- Dr. Midori Shima, Professor at Nara Medical University is explaining the therapeutic benefits of Hemlibra "Hemlibra has the potential to become the standard of care for hemophilia A, and is considered the most advanced treatment available." Dr. Midori Shima, professor of pediatric hematology-oncology at Nara Medical University in Japan, said so at a media session to mark the 1st anniversary of Hemlibra's insurance reimbursement extension at the InterContinental Seoul COEX. In the Phase III HOHOEMI trial, pediatric participants under the age of 12 saw significant joint health benefits and improved quality of life after taking Hemlibra. Professor Shima said, "Most people with hemophilia undergo knee and hip surgery in their 30s and 40s due to bleeding. Although long-term follow-up is required, our current results suggest that starting Hemlibra in childhood can help maintain knee joint health well into middle age.” Also, the 3-year interim analysis results of the AOZORA study showed that the annualized bleed rate (ABR) reductions seen in the HOHOEMI study were maintained. The mean ABR decreased from 0.4 (0.00-4.55) to 0.2 (0.00-4.04) before and after treatment with Hemlibra, respectively, and 40% of participants (12) had no bleeds. The AOZORA study will continue to track patients' MRI data through Week 313 and is expected to show that Hemlibra is effective in maintaining and improving joint health in pediatric hemophilia A patients. In addition, Hemlibra has 8 years of post-marketing surveillance data, including exposure data from 22,000 patients worldwide, demonstrating its safety and efficacy. For example, the Canadian registry study has efficacy and safety data from 553 patients of various lifestyles and ages. The study confirmed efficacy in preventing long-term bleeding, with 72.9% of patients with severe hemophilia A experiencing no bleeding. In addition, patient-to-patient comparisons showed a reduction in mean ABR. The mean ABR before treatment with Hemlibra was 1.22, and the mean ABR after treatment was 0.50. These data demonstrate that Hemlibra can safely and effectively prevent bleeding over the long term in a diverse patient population. Dr. Seema explained that Hemlibra prophylaxis offers multiple benefits for each patient group by age and lifestyle.. First, in pediatric patients, all previous prophylaxis treatments to reduce bleeding have required 2-3 intravenous injections per week, but Hemlibra can be administered as a subcutaneous injection once a week, once every two weeks, up to once every four weeks. This extended duration and convenience in administration means that patients can start prophylaxis at a younger age, which can have a significant impact on quality of life. "By starting prophylaxis early and maintaining regular prophylaxis, pediatric patients can maintain healthy joints without bleeding problems and prevent or minimize the impact of future arthropathies," said Dr. Shima. Hemlibra may also improve the patient’s ability to participate in academic and professional activities by reducing bleeding rates. The bruising and scarring of blood vessels that can occur with intravenous infusions may be eliminated by switching to subcutaneous infusions, improving the quality of life during this important developmental stage of a patient's life, including the ability to form social relationships. It is also notable that the risk of bleeding complications is significantly reduced in patients receiving Hemlibra, which may improve surgical outcomes. Most minor surgeries (e.g., dental procedures) can be performed without the need for additional clotting factor infusions. Therefore, the use of Hemlibra may minimize the need for transfusions of clotting factor concentrates or other blood products during and after surgery. This means that potential complications associated with transfusions can be avoided, contributing to a faster recovery period and shorter hospital stay, which would allow patients to return to their daily activities sooner. Meanwhile, JW Pharmaceutical's Hemlibra is an innovative new drug that works by mimicking the function of Factor VIII, a blood clotting factor that is deficient in the body of hemophilia A patients. Bispecific antibody technology was applied to the drug to simultaneously bind to factor IXa and factor X. Hemlibra is the only hemophilia A treatment that can be used in patients with and without antibodies who are resistant to existing factor VIII agents. It provides long-lasting bleed prevention with subcutaneous injections once every up to four weeks.
- Company
- More data on Leclaza·Lorviqua showcased
- by Son, Hyung-Min Jun 05, 2024 05:47am
- Positive clinical results for targeted therapies, such as EGFR and ALK, were featured at the international conference. Clinical achievements of major targeted therapies for non-small cell lung cancer (NSCLC), including Leclaza, Rybrevant, and Lorviqua, were presented at the American Society of Clinical Oncology (ASCO 2024) annual meeting in Chicago, U.S., on May 31. For Leclaza, subcutaneous (SC) Rybrevant combined with Leclaza was found to be effective as well as intravenous (IV) Rybrevant combined Leclaza. Leclaza plus Rybrevant combination therapy has been submitted for U.S. Food and Drug Administration (FDA) approval as a first-line treatment of EGFR-positive NSCLC. Pfizer’s Lorviqua, a targeted drug used to treat ALK-positive NSCLC, demonstrated clinical benefit in patients who had no treatment experience. Based on these clinical results, Lorviqua garners attention for use as a first-line treatment compared to its competitors, such as Alecensa and Alunbrig. Leclaza combined with SC Rybrevant injection offers benefit The clinical results of Leclaza plus SC Rybrevant combination therapy were presented during ASCO 2024 on May 31st. This combination therapy is undergoing trials for potential use as a first-line treatment for EGFR-positive NSCLC, and the developer plans to secure ease of administration as well. Unlike the oral formulation of Leclaza, Rybrevant was developed as an IV injection. For Rybrevant IV inj, patients have the inconvenience of visiting the hospital once every 2-3 weeks, and the administration takes more than an hour. Janssen plans to develop an SC formulation to offer ease of administration and reduce concern regarding adverse reactions related to injection. SC formulation is expected to improve patient convenience since it can significantly reduce the administration duration to within 10 minutes. PALOMA-3 Phase 3 study design to evalute the efficacy of Leclaza plus SC Rybrevant inj (source: snapshot of ASCO 2024 lecture presentation). The Phase 3 PALOMA-3 study has evaluated the efficacy and safety of Leclaza plus SC Rybrevant combination therapy compared to Leclaza plus IV Rybrevant combination therapy in patients with EGFR-positive NSCLC who have failed previous treatments. The study enrolled 418 patients with advanced or metastatic NSCLC who have EGFR exon 19 deletions or exon 21 mutations. The primary endpoint of the study was the non-inferiority assessment of Leclaza and SC Rybrevant combination therapy in pharmacokinetics aspect. The secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR), patient satisfaction, and safety. At a median follow-up of 7 months, Leclaza plus SC Rybrevant combination therapy showed non-inferiority compared to Leclaza plus IV Rybrevant combination therapy. Leclaza plus SC Rybrevant combination therapy had an ORR of 30.1%, whereas Leclaza plus IV Rybrevant combination therapy had an ORR of 32.5%, meeting the non-inferiority requirement. Leclaza plus SC Rybrevant combination therapy showed a positive trend in terms of PFS. For infusion-related reactions (IRR), Leclaza plus SC Rybrevant combination therapy had 13% of IRR, which was significantly lower than the 66% of IRR for Leclaza plus IV Rybrevant combination therapy. Whether the SC formulation therapy would overcome the IRR adverse reactions observed in the MARIPOSA study, which evaluated the efficacy of Leclaza plus IV Rybrevant combination therapy is to be watched. Five-year follow-up data of Lorviqua have been disclosed…60% of patients had PFS Dr. Benjamin J. Solomon presented the CROWN clinical study results, which confirmed Lorviqua’s five-year survival benefit as the third-generation targeted therapy for ALK-positive cancer (source: snapshot of ASCO 2024 lecture presentation). On May 31st, the five-year follow-up clinical data of Lorviqua, a targeted drug for the treatment of ALK-positive NSCLC, were disclosed at ASCO 2024. The CROWN Phase 3 study compared the efficacy of Lorviqua to Xalkori for the first-line treatment of ALK-positive NSCLC. Lorviqua is Pfizer’s third-generation targeted drug for the treatment of ALK-positive NSCLC. Along with Lorviqua, Takeda’s second-generation Alunbrig and Roche’s Alecensa compete in the market for targeted drugs for treating ALK-positive NSCLC. As Lorviqua’s effectiveness has been confirmed in five-year long-term data, all eyes in the industry are on whether it will take the lead in the competition among first-line treatments. The clinical trial involved 296 patients with ALk-positive NSCLC who had no prior treatment experience. The patients were randomly assigned to the Lorviqua treatment group and the Xalkori treatment group by a 1:1 ratio. According to the clinical result, during the follow-up period of 60.2 months, the Lorviqua treatment group did not reach the median PFS value. The Xalkori treatment group recorded 9.1 months of PFS during the follow-up for 55.1 months. For the five-year PFS rate, 60% of the Lorviqua treatment group reached the PFS, whereas 8% of the Xalkori treatment group reached the PFS. Furthermore, 77% of the Lorviqua treatment group had Grade 3-4 adverse reactions (AE), whereas 57% of the Xalkori treatment group had Grade 3-4 AE. The safety profile was aligned with that observed in the previous analysis. Dr. Benjamin J. Solomon, Professor of Peter MacCallum Cancer Centre in Australia, said, “Based on the results of the five-year follow-up data of Lorviqua and Xalkori treatment groups, the Lorviqua treatment group’s media PFS value has not been reached. This is the longest reported PFS among advanced NSCLC.” He added, “Without any additional safety issues, this will be the unprecedented outcome among ALK-positive NSCLC clinical results.”
- Policy
- Gov’t will maintain criteria for KIPC recertifications
- by Lee, Jeong-Hwan Jun 05, 2024 05:47am
- The government has decided to maintain the recertification process and criteria for Korea Innovative Pharmaceutical Companies. Therefore, the government decided not to accept the demands of some in the pharmaceutical industry on easing the decertification regulations, ‘2 or more rebate detections and administrative disposition’, and the 'total rebate amount that exceeds KRW 5 million’ regulations. Based on the maintained regulations, pharmaceutical companies that fall under the current disqualification criteria for innovative pharmaceutical companies, such as the rebate detection regulation, are expected to fail recertifications. On the 3rd, an official from the Ministry of Health and Welfare explained, "We will proceed according to the current regulations, and will not accept complaints from the pharmaceutical industry about easing the decertification criteria." This month, the recertification process will be carried out for Korea Innovative Pharmaceutical Companies certified on June 20, 2021, based on the Special Act on Fostering and Supporting the Pharmaceutical Industry. Currently, the 28 companies include ▲GC Biopharma, ▲Daewoong Pharmaceutical, ▲Daewon Pharm, ▲Daehwa Pharm, ▲Medytox, ▲Helixmith, ▲Boryung Pharmaceutical, ▲Bukwang Pharmaceutical, ▲BC World Pharm, ▲Samyang Holdings, ▲Celltrion, ▲Shin Poong Pharmaceutical, ▲ST Pharm, ▲Yuhan Corp, ▲Isu Absix, ▲Chong Kun Dang, ▲Crystal Genomics, ▲Taejoon Pharm, ▲Korea Otsuka Pharmaceutical, ▲Korea United Pharm, ▲Genuone Sciences, ▲Handok, ▲Hanlim Pharm, ▲Hanmi Pharmacuetical, ▲Hyundai Pharm, ▲HK Inno.N, ▲LG Chem, and▲SK Chemical. The companies reportedly submitted the written evaluation materials required for the recertification last month and completed an interview evaluation. Specifically, the written evaluation consists of 25 criteria, including excellence in R&D resource input, innovation in R&D activities, excellence in technological and economic performance, and corporate social responsibility, ethics, and management transparency. The interview evaluation consists of 5 criteria on innovation in R&D activities such as R&D vision, mid- to long-term promotion strategy, and the company’s social responsibility and ethics. Several pharmaceutical companies that submitted documents to extend their certification claimed that it was unfair to revoke the innovative pharmaceutical company status, which is certified based on the percentage of investment in R&D for new drugs, for illegal drug rebates, which is an individual deviant behavior. They also raised the need to ease the rebate criteria for decertifying innovative pharmaceutical companies. They requested that the 2 two administrative dispositions on rebates and the total amount of rebates paid that exceed KRW 5 million thresholds should be eased. However, the MOHW has decided not to accept these complaints from the pharmaceutical industry this time. The reasoning is that there are already companies that have been decertified under the current regulations, so it would be unfair to change the criteria, and there is no consensus within or outside the MOHW on the feasibility of easing the rebate criteria. A MOHW official said, "If any of the 28 pharmaceutical companies whose innovative pharmaceutical company certification period expires apply for recertification, they will be judged according to the current criteria without changing the criteria such as disqualification reasons. We are not considering the pharmaceutical industry's request to ease the criteria for decertification.” As such, the 28 pharmaceutical companies whose certification was extended in 2021 and expires in June this year will be evaluated on whether to be granted recertification as innovative pharmaceutical companies based on the current criteria, including whether or not they are subject to administrative dispositions for illegal rebates. The MOHW plans to confirm and notify the recertification decision within this month after deliberations by the Pharmaceutical Industry Development and Support Committee earlier this month.
- Company
- Sprycel patent to expire soon…market shift worth KRW 40 bil
- by Nho, Byung Chul Jun 04, 2024 05:48am
- Sprycel’s compound patent for its protein tyrosine kinase inhibitor expired in March. Following the patent expiration for blockbuster medicines in the United States this year, generics are expected to enter the market. Likewise, market shifts are expected with the development and launch of generics in South Korea. According to an overseas research agency, the top 10 blockbuster medicines with patents expiring in 2024 include Sprycel, Tysabri, Myrbetriq, Victoza, Sandostatin LAR, Dulera, Oxtellar XR, and Venofer. Among these, Sprycel has the highest sales, with prescription sales totaling over KRW 2 trillion in the United States. Tysabri and Myrbetriq recorded sales totaling approximately KRW 1.3 trillion and KRW 870 billion, respectively. Victoza and Emflaza have also recorded sales of KRW 710 billion and KRW 340 billion, respectively. Dulera, Sandostatin LAR, and Oxtellar XR have reached significant external growth, with sales of KRW 260 billion, KRW 160 billion, and 150 billion, respectively. They are showing solid sales in the United States. However, the sales performance of these drugs in South Korea is quite different from the positions in the United States. Following the expiration of patents in the United States, medicines that are expected to launch in South Korea are likely limited to BMS’ Sprycel (dasatinib), a leukemia treatment, Novartis’ Sandostatin LAR (octreotide acetate), used to treat cancer, due to non-reimbursement issues. According to the pharmaceuticals market report, Sprycel sales in South Korea for the past five years (2019-2013) amounted to KRW 29.6 billion, KRW 34.1 billion, KRW 390 billion, and KRW 40.1 billion. The Sandostatin LAR inj sales in 2019, 2020, 2021, 2022, and 2023 amounted to KRW 9.6 billion, KRW 9.3 billion, KRW 9.3 billion, KRW 8.9 billion, and KRW 8.6 billion, respectively. South Korea sales performance of medicines with U.S. patents expiring in 2024. (from the top) Venoferrum, Victoza, Sandostatin LAR, Sprycel, and Tysabri. Sprycel, which received FDA approval in 2006, has been indicated for the second-line treatment of patients who do not respond to other medicines, such as Gleevec and Tasigna. Subsequently, it has been prescribed as the first-line treatment since 2010. Sprycel’s compound patent for its protein tyrosine kinase inhibitor expired in March, so generics are expected to launch starting in November due to agreements made with other companies, including Apotex, ahead of the patent expiry. Xspray Pharma also initially planned to release the incrementally modified drug (IMD) Dasynoc within the second half of 2023. Yet, it is expected to be released in Q3 this year due to monitoring several issues. Three-types of patents protect Sprycel. Its substance and use patents have expired in April 2021 and March 2024. The crystalline form patent will remain until February next year. In South Korea, Boryung is actively pursuing Sprycel generics, filing claims to confirm the scope of a right and challenging substance patent through invalidation trial. Although the Sandostatin LAR patent has already expired in Europe and Japan, its generic version has not been released due to the delicate manufacturing process. However, Viatris is likely challenging the original product. JW Pharmaceutical’s iron therapy, Venoferrum Inj (Ferric Hydroxide Sucrose Complex), and Novo Nordisk’s diabetes drug, Victoza inj (liraglutide), have been launched in South Korea. Since these drugs generated KRW 3.2 billion and KRW 170 million, respectively, last year, generic entries would not experience much growth expansion. Eisei’s Tysabri Inj (natalizumab), a multiple sclerosis therapy, generated sales ranging between KRW 30 million and KRW 60 million, but did not experience significant external growth.
- Policy
- Lorviqua fails to receive reimb as first-line therapy
- by Lee, Tak-Sun Jun 04, 2024 05:47am
- The reimbursement extension application for Lorviqua, a treatment for anaplastic lymphoma kinase (ALK)-positive non-small-cell cancer, has failed to go beyond the negotiation stage with the National Health Insurance Service. With the breakdown of the negotiations, the company will have to start over from the application stage for Lorviqua’s reimbursement According to industry sources, Pfizer Korea’s recent negotiations with the National Health Insurance Service for Lorviqua’s reimbursement(NHIS) fell through. Lorviqua is a treatment for ALK (anaplastic lymphoma kinase) positive non-small cell lung cancer, that was listed for reimbursement in September 2022. The drug is currently reimbursed to treat patients with advanced or metastatic ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib (brand name: Alecensa) or ceritinib (Zykadia) or Xalkori (crizotinib) as first-line ALK tyrosine kinase inhibitor (TKI) therapy, However, patients who received crizotinib (Xalkori) as a first-line ALK inhibitor may also have received alectinib, ceritinib, or brigatinib as a second-line ALK inhibitor and can use Lorviqua with reimbursement. In other words, the drug is covered as second-line or later therapy in patients who have not responded to prior first-line or first- or second-line agents. Lorviqua has become a blockbuster drug since its reimbursement, posting sales of KRW 11.7 billion last year, according to IQVIA. Pfizer has been pushing to extend Lorviqua’s reimbursement to first-line based on clinical data. In January, the Drug Reimbursement Review Committee deemed the drug's reimbursement extension adequate if the company is willing to accept a price lower than the assessed value. Since then, Pfizer has been conducting drug pricing negotiations with the National Health Insurance Service, accepting the committee's opinion. However, the negotiations fell through after the company and the government failed to reach an agreement on the terms of the risk-sharing agreement scheme, etc. As a result, the company will have to start all over again from the reimbursement application stage. At the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024), which kicked off last month in Chicago, Pfizer unveiled the 5-year follow-up data on Lorviqua showing a progression-free survival rate of 60%, which is significantly higher than the 8% in the Xalkori arm. The data showed Lorviqua’s advantage in the first-line treatment environment. However, due to its failure to receive reimbursement extensions, existing first and second-line therapies will continue to dominate Korea’s ALK-positive targeted therapy market. Pfizer is reportedly planning to reapply for reimbursement as soon as possible.
- Company
- Indication for rare cancer drug Retevmo is expanded
- by Son, Hyung-Min Jun 04, 2024 05:47am
- The indication for Retevmo, which targets a rare disease mutation in lung cancer, has been expanded to include children with solid tumors across the spectrum. Retevmo is approved in South Korea for lung cancer but not reimbursed in Korea. It will be interesting to see if the additional confirmation of clinical efficacy will have an impact on its insurance reimbursement progress in Korea. According to industry sources on the 1st, the U.S. Food and Drug Administration (FDA) expanded the approval for Retevmo, a treatment targeting the RET (REarranged during Transfection) gene mutation, for pediatric patients with thyroid cancer and solid tumors for which there are no treatment alternatives. As a result, Retevmo became the first targeted therapy for pediatric patients with RET-mutant cancers under the age of 12. This is an accelerated approval and is subject to further confirmatory clinical studies to determine full approval. In addition to the existing RET-mutant lung cancer indication, Retevmo is now available for pediatric patients with RET-mutant metastatic medullary thyroid cancer, RET-mutant radioactive iodine-refractory advanced or metastatic thyroid cancer, and RET-mutant locally advanced or metastatic solid tumors for which there are no alternative treatment options during or after systemic therapy. The expanded approvals were based on the Phase I/II LIBRETTO-121 trial, which assessed Retevmo in 25 patients aged 2-20 with advanced or metastatic RET-activated solid tumors who had little response. The primary endpoints were overall response rate (ORR) and duration of response (DOR). Results showed a confirmed ORR of 48%, as determined by a blinded independent review committee. The median duration of response (DOR) was not reached and 92% of responders had responses lasting 12 months. In terms of safety, the most common adverse events were musculoskeletal pain, diarrhea, headache, nausea, vomiting, coronavirus infection, abdominal pain, fatigue, pyrexia, and bleeding. The most common grade 3 or 4 adverse reactions were calcium decrease, hemoglobin decrease, and neutropenia. Sustained responses were observed in pediatric and young adult patients with RET-mutated pheochromocytoma. The most common adverse reactions reported were musculoskeletal pain, diarrhea, headache, nausea, vomiting, COVID-19, abdominal pain, fatigue, pyrexia, and hemorrhage. The most common grade 3 or 4 laboratory abnormalities were decreased calcium, hemoglobin, and neutrophils. Retevmo makes slow domestic reimbursement progress Currently, Retevmo is making slow reimbursement progress in Korea. In May last year, Retevmo was recognized for its reimbursement adequacy by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee, but since failed to negotiate drug prices with the National Health Insurance Service and remains unreimbursed. In particular, with Roche's RET mutant-targeted therapy Gavreto withdrawn from the market, Retevmo is the only drug in the market but is not easily administrable due to its non-reimbursed status. In Korea, Retevmo is approved for the treatment of▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. NSCLC patient with RET mutation is classified as a rare cancer. RET mutations occur in 2 to 6 % of all NSCLC cases and are more often found in adenocarcinomas and younger patients under 60 years of age and non-smokers. In NSCLC, RET fusions occur more than RET mutations. In thyroid cancer, RET fusions are reported in up to 40% of the cases. While there are several treatments available for EGFR-mutant lung cancer, including Tagrisso, Leclaza, and Rybrevant, Retevmo remains the only option for RET-mutant lung cancer. Therefore, it will be interesting to see if Retevmo, which has expanded its indications to pediatric thyroid cancer and solid tumors, can play an active role in Korea.
- Company
- Evolution of ADCs… Enhertu prolongs OS in solid tumors
- by Son, Hyung-Min Jun 04, 2024 05:47am
- The antibody-drug conjugate (ADC) anticancer drug Enhertu has demonstrated further efficacy across multiple solid tumors, including HER2-low breast, biliary tract, and head and neck cancers. With the clinical results, the company secured momentum to add more solid tumors to Enhertu’s already established breast, gastric, and non-small cell lung cancer indications. Enhertu is Daiichi Sankyo and AstraZeneca’s ADC anticancer drug. Enhertu is a next-generation ADC that combines a monoclonal antibody with the same structure as trastuzumab, which binds to a specific target receptor overexpressed on the surface of cancer cells, and a topoisomerase I inhibitor payload with a tumor-selective cleavable linker, a novel and highly potent mechanism of action. Enhertu has been recognized for overcoming the limitations of existing therapies and is effective across solid tumors, not for just a single indication. Enhertumakes strides in HER2-low breast cancer According to industry sources on the 3rd, additional clinical data on Enhertu was presented at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024) that is being held in Chicago, U.S. On the 2nd, results from the DESTINY-BREAST06 trial, which demonstrated the additional benefit of Enhertu in HER2 low-expression breast cancer, were presented at ASCO 2024 (Source: ASCO 2024 lecture capture) The clinical trial evaluated the efficacy and safety of Enhertu in patients with HR-positive, HER2-low or HER2-ultralow advanced or metastatic breast cancer whose disease progressed following one or more lines of endocrine therapy. The HER2-low arm included immunohistochemistry (IHC) 1 or 2/fluorescent in situ hybridization (ISH) negative patients, and the ultra-low-expression arm included IHC 0 patients. The participants were randomly assigned 1:1 to receive either Enhertu or the investigator’s choice of chemotherapy (capecitabine, nab-paclitaxel, or paclitaxel). The primary endpoint is PFS in the HR-positive, HER2-low patient population as measured by a blinded independent review committee (BICR). Key secondary endpoints include PFS by BICR in the overall trial population (HER2-low and HER2-ultralow), OS in the HER2-low patient population, and OS in the overall trial population. Other exploratory endpoints included objective response rate (ORR) and safety. Study results showed that the median PFS with Enthertu was 13.2 months in the HER2-low cancer patient population, which was longer than the 8.1 months in the chemotherapy arm. The difference was also evident in the HER2-ultralow patient population. PFS was 13.2 months in the Enhertu arm versus 8.3 months in the chemotherapy arm. In patients with HER2-low expression, the confirmed objective response rate (ORR) was 56.5% for Enhertu versus 32.2% with chemotherapy, and in patients with HER2-ultralow expression, the confirmed ORR was 61.8% versus 26.3%, respectively. The OS data were immature. The researchers concluded that "Enhertu could become a new standard of care for patients with hormone-positive breast cancer following endocrine therapy in the metastatic setting.” Demonstrated prolonged survival in head and neck, biliary, and pancreatic cancers Enhertu has also demonstrated survival benefits in head and neck, biliary tract, and pancreatic cancers. The DESTINY-Pantumor02 trial verified Enhertu’s efficacy in patients with previously treated pancreatic, ovarian, cervical, bladder, biliary, endometrial, or other tumors. Based on the trial results, Enhertu’s indication was expanded across HER2 solid tumors for which there are no treatment alternatives. The study presented at ASCO 2024 is a follow-up to DESTINY-Pantumor02 in head and neck, biliary tract, and pancreatic cancers. The Phase II study evaluated the efficacy of Enhertu in patients with locally advanced, metastatic HER2-positive head and neck cancer following systemic therapy. The primary endpoint was ORR; secondary endpoints included DOR, PFS, disease control rate (DCR), and safety; and exploratory endpoints included efficacy outcomes by HER2 expression. At the time of data cutoff (June 2023), 24 patients with head and neck cancer were evaluated, resulting in an ORR of 41.7% for Enhertu. Median DOR was 22.1 months and the median PFS was 12.4 months. Safety was consistent with known safety profiles. In the DESTINY-Pantumor02 subgroup analysis, Enhertu also showed promise in pancreatic and biliary cancers. In this study, Enhertu achieved a primary endpoint ORR of 22.0% and a median PFS of 4.6 months. These results are paving the way for Enhertu to expand its indication across all solid tumors with HER2 expression.
- Company
- 'Jemperli,' a PD-1 inhibitor immunotherapy lands in Big 5
- by Eo, Yun-Ho Jun 04, 2024 05:46am
- GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab). 'Jemperli,' the first immunotherapy for endometrial cancer, has landed in Big 5 general hospitals. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has cleared the Drug Committee (DC) of the nationwide medical institutes, including Samsung Medical Center in Seoul, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. After being listed for reimbursement in December, Jemperli is now readily available for prescription. The efficacy of Jemerli was demonstrated through cohort A1 analysis results of the GARNET study. GARNET was a multiple cohort, open-label study, including patients with recurrent or advanced solid cancer. Cohort A1 enrolled patients with recurrent or advanced dMMR/MSI-H endometrial cancer who have shown progression after platinum-based systemic chemotherapy. Notably, the size of Cohort A1 was the largest among PD-1 inhibitor monotherapy studies involving patients with dMMR/MSI-H endometrial cancer to date. The study’s primary endpoints were objective response rate (ORR) and duration of response (DOR), and these were assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria Solid Tumors (RECIST). The analysis of 108 patients at 16.3 months, a median value of the follow-up period, Jemperli showed consistent anti-tumor activities and a manageable safety profile. The treatment group had ORR of 43.5%, and its DOR has yet to reach the median value. A disease control rate (DCR) of 55.6% was recorded, and 97.9% and 90.9% of the patients had treatment responses that continued for 6 months and 12 months, respectively. Meanwhile, an expanded indication for Jemperli in combination with platinum-based chemotherapy was approved for the first-line treatment of patients with advanced or recurrent DNA Mismatch Repair Deficient/Microsatellite Instability-High (dMMR/MSI-H) endometrial cancer. Jae-Hoon Kim, Professor of the Department of Obstetrics and Gynecology at Gangnam Severance Hospital, said, "Platinum-based chemotherapy has been used as the first-line standard therapy for advanced or recurrent endometrial cancer, but the patients had unmet needs due to poor prognosis, with the average of overall survival period being less than three years. Therefore, we have high hopes for the clinical significance of Jemperli for the first-line treatment."
- Policy
- Takeda’s Zejula Tab receives marketing authorization in KOR
- by Lee, Hye-Kyung Jun 03, 2024 05:49am
- Takeda Pharmaceuticals’ poly ADP-ribose polymerase Inhibitor ‘Zejual (niraparib)’ has been granted marketing authorization in Korea in its tablet form. The Ministry of Food and Drug Safety (MFDS) approved Zejula Tab 100 mg on the 31st. Like its capsule formulation, Zejula Tab is indicated ▲as monotherapy for adult patients with ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have shown response (partial or complete response) to first-line platinum-based chemotherapy; ▲ as monotherapy for adult patients with platinum-sensitive recurrent high-grade serous ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have responded (partial or complete response) to two or more lines of platinum-based chemotherapy. Its capsule formulation, Zejula Cap had been approved in Korea in 2019 as the first PARP inhibitor for use in patients regardless of BRCA mutations. Patients only need to take two 100 mg tablets once daily, making it the only once-daily treatment available for ovarian cancer. In a pivotal clinical study, Zejula demonstrated a significant improvement in median progression-free survival (mPFS) compared to placebo in patients with and without BRCA mutations. Among patients with ovarian cancer who have BRCA mutations, patients treated with Zejula had a mPFS of 21.0 months, which was 4 times longer than the 5.5 months confirmed in the placebo arm. In patients without BRCA mutations, mPFS with Zejula was 9.3 months, compared with the 3.9 months in the placebo arm, a clinically significant difference. In the U.S., Zejula is an "all-comer" that is reimbursable for all ovarian cancer patients, but in Korea, it is only available as first- and second-line maintenance therapy for patients who showed response to platinum-based chemotherapy. In April, a proposal to extend Zejula’s reimbursement as first-line maintenance therapy cancer to cover HRD-positive patients in addition to the current BRCA mutation-positive patients for unresectable ovarian cancer was submitted to the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee, but rejected due to its unclear reimbursement adequacy. Meanwhile, Zejula and Lynparza (olaparib) are the only PARP inhibitors in Korea with an indication for maintenance therapy for ovarian cancer.
- Company
- AbbVie’s Rinvoq is reimbursed for Crohn's Disease in KOR
- by Son, Hyung-Min Jun 03, 2024 05:49am
- Byong Duk Ye, Professor of Gastroenterology at Asan Medical Center, Rinvoq’s reimbursement has been extended to cover Crohn's disease and ulcerative colitis in Korea. With this reimbursement extension, Rinvoq became the first and only JAK inhibitor that is reimbursed to treat adults with moderate-to-severe Crohn's disease. The treatment has been shown high effect not only in controlling symptoms but also in mucosal healing, which is expected to increase its use. On the 31st, AbbVie Korea held a press conference at the Sofitel Ambassador Seoul Hotel in Jamsil to celebrate the reimbursement of Rinvoq for adult patients with moderate-to-severe active ulcerative colitis and Crohn's disease in Korea. Rinvoq is a Janus kinase (JAK) inhibitor developed by AbbVie and indicated for ulcerative colitis, Crohn's disease, atopic dermatitis, ankylosing spondylitis, and psoriatic arthritis. In Korea, the drug became reimbursable for the treatment of patients with moderate-to-severe ulcerative colitis who have had an inadequate response or intolerance to conventional therapies such as corticosteroids, 6-mercaptopurine or azathioprine, or for whom these agents are contraindicated. It is also reimbursable for the treatment of patients with moderate-to-severe active Crohn's disease (Crohn's Disease Activity Index (CDAI) of 220 or greater) who have had an inadequate response or intolerance to conventional therapies In addition to ulcerative colitis and Crohn's disease, RInvoq is covered for the treatment of moderate-to-severe active rheumatoid arthritis in adults, moderate-to-severe active ankylosing spondylitis in adults, and severe atopic dermatitis in adults and adolescents. Inflammatory bowel disease (IBD) is a chronic inflammatory condition characterized by abnormal immune responses in the intestinal tract and recurrent episodes of inflammation caused by both internal and external factors. Typical IBD describes 2 main conditions, ulcerative colitis and Crohn's disease. These disorders are characterized by recurrent gastrointestinal symptoms such as diarrhea, bloody stools, and abdominal pain that significantly interfere with daily life, due to which patients who have been unsuccessfully treated have been expressing a dire need for effective new treatment options. In clinical trials, RInvoq has demonstrated rapid symptom control as well as mucosal healing. In a Phase III trial studying its effect in ulcerative colitis, Rinvoq demonstrated significant improvements in histologic-endoscopic assessments, including endoscopic improvement, histologic improvement, and histologic-endoscopic mucosal improvement over placebo. In the two induction studies, RInvoq demonstrated endoscopic improvement at week 8 in 36% and 44% of patients, compared with the 7% and 8% shown in the placebo arm of the two studies, respectively. In the maintenance studies, up to 62% of the patients treated with Rinvoq for 52 weeks achieved endoscopic improvement. The onset of clinical response occurred as early as Week 2 in the induction therapy study, with a higher percentage of patients achieving clinical response at Week 2 in the Rinvoq treatment arm compared to the placebo arm. Rinvoq also demonstrated significant improvements in endoscopic endpoints, including endoscopic response and mucosal healing, compared to placebo In a Phase III trial on Crohn's disease, In two induction studies, endoscopic response rates were 35% and 46% at Week 12, compared with 4% and 13% in the placebo group. In the maintenance studies, RInvoq also improved endoscopic response and remission over placebo. Byong Duk Ye, Professor of Gastroenterology at Asan Medical Center, said, “If inflammatory bowel disease is not treated properly, complications such as fistulas and perforations can occur, and the risk of colorectal cancer can increase. Many treatments have been introduced to the field, but they have been lacking in terms of mucosal healing and ease in administration." "Rinvoq has shown high efficacy in mucosal healing as well as symptom control in clinical trials. Also, its once-daily dosing is convenient for the patients. We are excited to be able to provide patients with a more effective treatment option with the reimbursement extension. Rinvoq is a drug that has also been verified in the real world."
