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- 2026-04-10 05:23:34
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- Lyumjev can be prescribed at general hospitals
- by Eo, Yun-Ho May 31, 2023 05:37am
- According to related industries, Korea Lily's Lyumjev has passed the Drug Committee of medical institutions such as Samsung Seoul Hospital, Seoul National University Hospital, Seoul Asan Hospital, Gangnam Severance Hospital, and Seoul National University Bundang Hospital. This drug was approved in Korea in December 2021, and insurance benefits were applied from September last year. Lyumjev, postprandial insulin, is an 'Insulin Lispro' formulation that shows a quick effect and helps lower blood sugar levels in type 1 and type 2 diabetics who have increased blood sugar after meals or who have difficulty maintaining the target blood sugar range. Domestic approval was made based on data from the PRONTO clinical program targeting adult patients with type 1 and type 2 diabetes. PRONTO-T1D and PRONTO-T2D are phase 3 clinical studies with treatment goals that compare major treatment effects such as hypoglycemia rate, postprandial blood glucose management, and optimal blood sugar maintenance time after each patient group is treated to reach the same blood sugar control level. According to the study results, Lyumjev demonstrated non-inferiority in reducing HbA1c compared to baseline at week 26, the primary endpoint, when administered after meals compared to Lilly's existing short-acting insulin drug Humalog. Humalog showed superiority over Humalog in preventing a rapid rise in blood glucose at 1 hour and 2 hours after eating. In the results of phase 1 clinical trial targeting patients with type 1 diabetes, Humalog was found to be absorbed into the bloodstream faster than Humalog Insulin aspart. Blood glucose results up to the first 3 hours after administration of Lyumjev showed similar patterns to non-diabetic participants.
- Policy
- Vemlidy IMDs compete with lower price
- by Lee, Tak-Sun May 31, 2023 05:37am
- Gilead The latecomers of the hepatitis B treatment Vemlidy that entered the market this year are focusing on their price competitiveness to occupy more shares of the market. Companies that had already reduced their price upon entry are also seemingly holding in check their competitors' prices. According to industry sources on the 29th, Daewoong Pharmaceutical reduced its insurance price ceiling for Vemliver Tab. (tenofovir ala fenamide hemitartar hydrochloride) from KRW 2,828 to KRW 2,473 from June. This is only 3 months after the drug was listed for reimbursement in March. Daewoong Pharmaceutical's voluntary price cuts are interpreted as being conscious of its competitors. Daewoong Pharmaceutical's product had been the most expensive among Vemlidy's latecomers in the market. Currently, all Vemlidy latecomers in the market are incrementally modified drugs that were developed with different salt formations. Dong-A ST, Daewoong Pharmaceutical, and Chong Kun Dang are competing in the market. With Donga ST being the first to be listed in February, Daewoong and Chong Kun Dang also launched their respective IMDs in March. The price of such salt-modified drug is allowed to be set at 90% of the original Vemlidy's highest price, but all three companies reduced the price to be lower than that at the time of initial listing. Dong-A ST’s Vemlia Tab was set at a 70% level at KRW 2,474, Chong Kun Dang’s at 69% at KRW 2,439, and Daewoong’s at 80% at KRW 2,828. All three products received generic marketing exclusivity. Not only were the drugs able to receive reimbursement a month faster than their competitors, but were allowed to sell their products without competition from other identical products for 9 months. The lower price set by the companies are therefore analyzed to be a measure the companies are making to preoccupy the market. Daewoong’s voluntary price cut made its drug KRW 1 cheaper than Donga ST’s Vemlia Tab. Vemlidy is on the rise in the hepatitis B treatment market. Gilead improved the tolerance and nephrotoxicity of its existing HBV treatment Viread and developed Vemlidy. The drug posted outpatient prescriptions of KRW 47.1 billion (UBIST) in Korea last year. Due to increased usage, Vemlidy's drug price was reduced 2 years in a row under the Price-Volume Agreement system. Last year, the price was cut from KRW 3,754 to KRW 3,535 after negotiations as a PVA ‘Type A’ drug, and this year, the price was cut from KRW 3,535 to KRW 3,370 through ‘Type B’ negotiations. This shows how rapidly Vemlidy's prescription volume has been increasing. Targeting this increasing market, the latecomers are aggressively marketing their drugs by lowering the insurance ceiling price. In addition, there is an analysis that the preoccupation of the market with such lower prices will create an entry barrier for other latecomers. In addition to the 3 pharmaceutical companies, Jeil Pharmaceutical, Korea Hutex Pharma, Samil Pharm, Dongkook Pharmaceutical, and Samjin Pharm have received approval for their salt-modified versions of Vemlidy.
- Company
- Samsung Bioepis, Soliris biosimilar approved in Europe
- by Chon, Seung-Hyun May 31, 2023 05:36am
- A view of Samsung Bioepis headquartersSamsung Bioepis announced on the 30th that it has obtained item permission from EC for Episcli, a biosimilar of Soliris, a treatment for rare diseases. On March 30, after obtaining a positive opinion for sales approval from CHMP under the EMA, the final approval was obtained two months later. Episcli is the first biopharmaceutical in hematology developed by Samsung Bioepis. Soliris is an ultra-expensive drug developed by Alexion of the US that is used for intractable rare diseases such as nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Last year, global sales amounted to about 5 trillion won. Samsung Bioepis demonstrated pharmacokinetic equivalence between Episcli and the original drug in phase 1 clinical trials conducted on healthy volunteers from November 2018 to March 2019. From August 2019 to October 2021, the clinical equivalence of Episcli and the original drug was confirmed through a global phase 3 clinical trial targeting patients with nocturnal hemoglobinuria in 8 countries. “Episcli has proven its equivalence through comparative clinical trials with original drugs, and we expect to contribute to resolving unmet demand for drugs by improving patient accessibility of ultra-high-priced drugs,” said Professor Jang Jun-ho of Samsung Medical Center’s Department of Hematology and Oncology. An official from Samsung Bioepis said, “We have a total of seven biosimilar products in the European market through Episcli approval.” I can do it,” he said.
- Company
- Verzenio prescribing guideline recommendations
- by Eo, Yun-Ho May 31, 2023 05:36am
- Verzenio is expected to be used in early breast cancer patients with a high risk of recurrence even after surgery. Looking at the recently published domestic and international breast cancer treatment guidelines, the CDK4/6 inhibitor Verzenio was recommended based on a high level of evidence as adjuvant therapy after surgery for patients with high-risk recurrence of early breast cancer with HR+/HER2- positive lymph nodes. In the 10th breast cancer treatment recommendation of the Korean Breast Cancer Society revised in April this year, patients who underwent surgery for HR+/HER2- breast cancer had 4 or more lymph node involvement, 1-3 benign lymph nodes, and tumor size of 5 cm or more or a high-risk tumor of grade 3 In order to reduce the recurrence rate of patients with factors, endocrine therapy and Verzenio combination treatment after breast cancer surgery were recommended as 'evidence level 1' and 'recommendation grade A'. Prior to the Korean Breast Cancer Society, the treatment guidelines of the National Comprehensive Cancer Network in the US were also revised in March. NCCN changed the level of evidence for 2 years of Verzenio + endocrine therapy as adjuvant therapy after surgery in HR+/HER2- high-risk breast cancer patients (the details are the same as in Korea) from category 2A to category 1, the highest grade. Verzenio's most recent data is the results of a 4-year follow-up study of monarchE, presented at the San Antonio Breast Cancer Symposium annual conference in December 2022 and published in The Lancet Oncology in January 2023. In the paper, the patient group treated with Verzenio + endocrine therapy had a reduced risk of recurrence and death compared to the control group until the 4th year after completing 2 years of postoperative adjuvant therapy, and the gap with the control group continued to increase until the 4th year. These results suggest the possibility that the risk of recurrence can be continuously reduced by maintaining endocrine therapy after completing Verzenio + endocrine therapy for 2 years. The monarchE study was a phase 3 study that confirmed the clinical efficacy and safety profile of Verzenio + endocrine therapy as adjuvant therapy after surgery for HR+/ HER2- lymph node-positive early breast cancer patients (N=5,637) at high risk of recurrence, compared to the existing standard endocrine therapy. a clinical study The monarchE cohort 1, which served as the basis for domestic approval, included 5120 patients (91%). The primary evaluation index was Invasive Disease-Free Survival (IDFS), and the secondary evaluation index was DRFS and OS. Looking closely at the results, Verzenio + endocrine therapy in monarchE cohort 1 reduced the risk of recurrence and death by about 35% at 4 years compared to endocrine therapy alone. The absolute difference of Verzenio gradually increased from 3.1% in the second year to 5.0% in the third year and 6.9% in the fourth year. The risk of distant recurrence and death was also reduced by approximately 35%, and OS has not yet been derived. Early breast cancer patients are treated with the goal of a complete cure, but in the case of recurrent or metastatic breast cancer patients, the goal is changed to treatment to prolong life and improve quality of life. Since the risk of recurrence is highest in the first 1 to 2 years after diagnosis, treatment to prevent recurrence after surgery is essential. About 14% to 23% of hormone receptor-positive (HR+) early breast cancer patients still experience recurrence even after surgery and endocrine therapy as an adjuvant treatment after surgery. In particular, according to a real-world study conducted in the United States, patients with recurrence risk factors defined in the IDFS, monarchE study showed about three times greater recurrence risk than breast cancer patients who did not. Among the risk factors for recurrence defined by monarchE, Cohort 1, the domestic approval standard, is ▲4 or more pALN, ▲1 to 3 positive axillary lymph nodes, and ▲ a tumor size of 5cm or more, ▲histological grade 3. While there was an unmet demand for more effective treatment options for the high-risk group for recurrence in the early stage of breast cancer, Verzenio obtained significant results in HR+/HER2- lymph node-positive high-risk early breast cancer with high-risk recurrence through the phase 3 trial of monarchE in 2020. And based on this, in November 2022, for the first time as a CDK4/6 inhibitor, it obtained approval from the Ministry of Food and Drug Safety in Korea as a combination therapy with endocrine therapy as an adjuvant treatment for adult patients with high-risk early breast cancer with HR+/HER2- positive lymph node recurrence. Jihyung Kim, Professor of Oncology at Gangnam Severance Hospital, said, “As a strategy to lower the risk of recurrence in early breast cancer patients, the introduction of new adjuvant drug therapy after surgery can improve the patient’s long-term treatment prognosis as well as reduce the possibility of recurrence or metastatic breast cancer. There are also benefits from the national fiscal perspective,” Kim said. Kim emphasized, “We hope that more domestic early breast cancer patients at high risk of recurrence can enjoy the treatment benefits of Verzenio through the application of domestic health insurance benefits for Verzenio, which has shown clinical usefulness for early breast cancer patients at high risk of recurrence.”
- Company
- 2 K-biosimilars are approved in the US and Europe per year
- by Chon, Seung-Hyun May 31, 2023 05:36am
- Biosimilar drugs that were developed in Korea are accelerating entry into the global market. Over the past decade, 13 and 10 biosimilars developed by Celltrion and Samsung Bioepis have been approved in Europe and the US, respectively. After Celltrion's Remsima received EMA approval in 2013, an average of 2 biosimilars have passed European and US review every year. According to industry sources on the 31st, Samsung Bioepis has obtained approval from the European Commission (EC) for 'Epysqli', a biosimilar of the rare disease treatment 'Soliris.’ Epysqli is the first biological drug developed by Samsung Bioepis in the field of hematology. Soliris is an ultra-high-priced drug developed by Alexion in the U.S. that is used for intractable rare diseases such as nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Last year, its global sales amounted to about KRW 5 trillion. With Epysqli’s approval, Samsung Bioepis has now been approved for 7 biosimilars in the European market. Samsung Bioepis started entry into the global market in earnest after receiving approval for its Enbrel biosimilar Benepali in Europe in January 2016. Then, in May 2016, the company also received approval for Flixabi, its biosimilar of the autoimmune disease treatment Remicade, in Europe. Also, the company received approval for biosimilars of the anticancer drug Herceptin and autoimmune disease treatment Humira in Europe in 2017. In 2020, it also acquired marketing authorization for its Avastin biosimilar, and then for the biosimilar of the eye disease treatment Lucentis in Europe in 2021. K-Biosimilars approved in the US and Euope Celltrion has acquired approval for 6 biosimilars in Europe. In August 2013, Celltrion first received approval for Remsima, the ‘world’s first biosimilar monoclonal antibody.’ Then, Celltrion received approval for Truxima and Herzuma in Europe in 2017 and 2018, respectively. Truxima and Herzuma are biosimilars of the anticancer drugs Mabthera and Herceptin. In November 2019, Celltrion received approval for its subcutaneous injection type of Remicade biosimilar Remsima SC in Europe and started market entry in earnest. Remsima SC is a biological drug developed by Celltrion. The company changed the intravenous formulation of its currently marketed Remsima into a subcutaneous injection (SC). In February 2021, Celltrion obtained European marketing authorization for Uplima, a biosimilar of Humira. In August of last year, Celltrion succeeded in obtaining European sales approval for Humira's biosimilar, Yuflyma. In 10 years since Celltrion received the approval for Remsima in Europe in 2013, a total of 13 biosimilars from Celltrion and Samsung Bioepis have been approved in Europe. Celltrion and Samsung Bioepis each received approval for 5 biosimilars in the US. In 2016, Celltrion’s Remicade biosimilar Inflectra became the first to pass the US barriers of approval. The company also received marketing authorization from the FDA for its Truxima and Herzuma in 2018. Celltrion received FDA approval for its Avastin biosimilar Vegzelma in September last year, and then for its Humira biosimilar Yuflyma on the 24th of this month. At Samsung Bioepis, its Remicade biosimilar ‘Renflexis’ became the first to receive FDA approval in April 2017. Since then, the company received approval for its Herceptin, Enbrel, and Humira biosimilars in 2019 from the FDA. In January 2019, its Herceptin biosimilar Ontruzant was approved in the U.S., followed by the approvals of Eticovo and Hadlima in April and July of the same year. The original products of the biosimilars Eticovo and Hadlima are Enbrel and Humira. Samsun Bioepis also received approval for its Lucentis biosimilar Byooviz in September 2021.
- Company
- Sales of Keytruda rose 117%
- by Chon, Seung-Hyun May 30, 2023 06:59pm
- Immuno-oncology drug Keytruda continued its high-altitude march in the domestic pharmaceutical market. Last year, Health Insurance 2 sales more than doubled as the number of recipients of the leading water-based benefits expanded for 13 consecutive quarters since the first quarter of 2020. Keytruda further strengthened its solo system by more than doubling the gap with second place. According to IQVIA, a drug research agency on the 22nd, Keytruda took the lead with sales of 87.8 billion won in the first quarter. Sales increased by 117.1% in one year from 40.4 billion won in the first quarter of last year. Released in Korea in 2015, Keytruda is an immune checkpoint inhibitor that inhibits the PD-1 protein on the surface of T-cells of immune cells to prevent binding to the PD-L1 receptor and activates immune cells to treat cancer. In Korea, 24 indications were approved for 16 cancer types, including melanoma, lung cancer, and head and neck cancer. Currently, the cancers for which Keytruda can be used are ▲lung cancer ▲head and neck cancer ▲Hodgkin's lymphoma ▲urothelial cancer (bladder cancer) ▲esophageal cancer ▲melanoma ▲renal cell cancer (kidney cancer) ▲endometrial cancer ▲stomach cancer ▲small intestine cancer ▲ovarian cancer ▲ Pancreatic cancer, biliary tract cancer, colorectal cancer (colorectal cancer), triple-negative breast cancer, and cervical cancer reached 16 cases. It can be used in the largest number of cancer types among immuno-anticancer drugs approved in Korea. Keytruda showed high growth last year thanks to the favorable news of salary expansion. In March of last year, the scope of health insurance coverage for Keytruda was expanded as the first treatment for non-small cell lung cancer. As Keytruda's first-line treatment benefit application effect began in earnest, the growth rate accelerated. Sales increased by 33.4% from 40.4 billion won in the first quarter of last year to 53.9 billion won in the second quarter. In the third and fourth quarters of last year, sales were 67.2 billion won and 78 billion won, respectively, raising more than 10 billion won in sales each quarter. Considering Keytruda's drug price cut, the increase in prescriptions is analyzed to be even greater. In March of last year, Keytruda's insurance cap was lowered by 25.6% as the benefits range expanded. In the aftermath of drug price cuts, sales in the first quarter of last year decreased by 26.0% compared to the previous quarter. However, despite the drug price cut, and the upward trends, Keytrua increased since the second quarter of last year. It is calculated that the amount used has more than doubled in one year since the first treatment benefit was applied. It has maintained its lead position for 13 consecutive quarters since taking first place overall in the first quarter of 2020. The gap with 2nd place Lipitor widened more than twice, establishing a solid solo system. New drug products recently introduced by multinational pharmaceutical companies continued to be strong at the top of pharmaceutical sales. Amgen's Prolia recorded sales of 35.5 billion won in the first quarter, up 41.6% from the same period last year, ranking third overall. Released in Korea in November 2016, Prolia is a biopharmaceutical osteoporosis treatment that targets RANKL, an essential protein for the formation, activation, and survival of osteoclasts that destroy the bone. Since 2017, Prolia began to enjoy an upward trend in sales after benefits were applied only to secondary treatment. From April 2019, sales of Prolia soared even more as insurance benefits were recognized for primary treatment. Prolia surpassed 100 billion won in annual sales last year, six years after entering the country. Prolia is jointly sold by Chong Kun Dang. Ono Pharmaceutical's immuno-oncology drug Opdivo recorded sales of KRW 33.9 billion in the first quarter, up 35.4% from the previous year. Opdivo, which was licensed in 2015, stayed in the 10 billion won range until the second quarter of 2021. It exceeded 20 billion won in the third quarter of 2021 and exceeded 30 billion won in the fourth quarter of last year. Opdivo recorded a high growth rate of 64.7% in two years from 66.7 billion won in 2020, and stepped on the 100 billion won mark in annual sales for the first time last year. Sanofi's atopic dermatitis treatment Dupixent recorded sales of 30.9 billion won in the first quarter, up 29.4% from the previous year. Dupixent is the first targeted biological agent developed for the treatment of moderate to severe atopic dermatitis where topical treatments are not recommended or symptoms are not adequately controlled. .Dupixent, which received domestic approval in March 2018, received coverage for severe atopic dermatitis from January 2020, and sales expanded rapidly.
- Product
- Prof Seong-Hoon Kim's research team reveals the mechanism
- by Jung, Heung-Jun May 30, 2023 05:33am
- From left, Yonsei University Prof. Seong-Hun Kim, Korea University Prof. Hwang Kwang-Yeon, Yonsei University Dr. Ina Yoon It is expected that domestic researchers will speed up the development of a new fibrosis treatment by uncovering the mechanism of action of Bersiporocin, which is being developed as a treatment for idiopathic pulmonary fibrosis. Yonsei University Professor Seong-Hoon Kim and Dr. Ina Yoon's research team conducted joint research with Professor Kwang-Yeon Hwang (Department of Biotechnology) of Korea University to identify the molecular mechanism that can explain the efficacy and safety of Bersiporocin at the same time. The research results were published in the world-renowned medical journal ‘EMBO Molecular Medicine’ on the 22nd (local time). Idiopathic pulmonary fibrosis is an incurable disease in which collagen is abnormally accumulated in the lungs and the function of the lungs is lost. It is a fatal disease with a poor prognosis, with a 5-year survival rate of only 40% after diagnosis. In particular, the existing approved treatments have severe side effects, so the development of new treatments is urgently needed. Bersiporocin inhibits the activity of prolyl-tRNA synthetase 1 (hereinafter referred to as PARS1), which is in charge of collagen synthesis and exhibits therapeutic effects. In the meantime, many researchers around the world have tried to treat fibrosis by regulating the activity of PARS1, but since PARS1 is an essential enzyme for maintaining life, excessive inhibition of PARS1 activity can cause side effects, making it difficult to develop new drugs. Suppressing the activity of PARS1 at a level that is safe for patients while exhibiting therapeutic effects has been the most important technology for new drug development. PARS1 exists in the form of a pair of two enzymes, and through this study, it was found that Bersiporocin binds asymmetrically to the pair of enzymes, thereby preventing excessive activity inhibition, thereby minimizing the side effects of the drug while exhibiting efficacy. Professor Kim Seong-Hoon said, “In order to realize precision medicine and secure the ability to develop new drugs at a global level, it is urgent to discover new drug targets with new mechanisms.” It is of great significance to prove that it is possible.” Bersiporocin is a first-in-class drug being developed by Daewoong Pharmaceutical as a treatment for idiopathic pulmonary fibrosis.
- Policy
- Lowest price of dapagliflozin set at 30% of original price
- by Lee, Tak-Sun May 30, 2023 05:33am
- Original In 2 months after the entry of generics in the market, the price difference between the original diabetes treatment Forxiga Tab (Dapagliflozin propanediol hydrate) and its generics has become one-third. This is because in April last year when many Forxiga generics were listed at once to exceed 20, the insurance price ceiling dropped significantly as the listed drugs were applied a stepped pricing model. According to the industry sources on the 26th, the upper insurance price limit was set at KRW 241 for Ahngook New Pharm's ‘Newpharm Dapagliflozin Tab. 10mg’ that was listed on June 1st. Its price had been set at 85% of the 38.69% of the highest price, as more than 20 identical drugs have already entered the market. When more than 20 identical drugs are listed, the price is set at 85% of the lowest price of identical drugs,or 38.69% of the upper limit of the same product, whichever is lower. Based on the calculation standards, the price has fallen to one-third of the original Forxiga’s 10mg highest price (KRW 734). In the case of Forxiga generics, 20 generics immediately entered the market, therefore any additional listings will continue to discount the price. Diabetes treatments such as Forxiga are so cheap, such differences in drug price do not have a significant impact on prescriptions. However, in the case of long-term prescriptions, the patient's burden of cost does increase. For example, Forxiga’s KRW 734 for 90 days amounts to KRW 66,060, whereas the cheapest generic’s KRW 241 for 90 days amounts to KRW 21,690. At 30% of the co-payment rate, the patients will have to bear at most KRW 19,818 for the original and KRW 6,507 for the lowest generic, bringing the price difference borne to KRW 13,311. In other words, the analysis is that generics can be a sufficient alternative to original drugs if the patient wants a cheaper option. However, in Korea, where doctors have the right to prescribe, not many doctors consider the economic feasibility during prescriptions. Therefore, the industry emphasizes that the government should focus on policies that encourage the use of cheaper generics, rather than concentrating only on devising formulas that can reduce drug prices. Meanwhile, the price of the original Forxiga was supposed to be forcibly reduced to KRW 514 following the introduction of generics, but the previous price of KRW 734 won has been maintained as AstraZeneca Korea, the seller, applied and was allowed a stay of execution for the pricing discount from the court.
- Company
- Imfinzi for liver cancer is expected to land in Korea soon
- by Eo, Yun-Ho May 30, 2023 05:33am
- According to related industries, the Ministry of Food and Drug Safety is in the process of final review for approval of Imjudo, a CTLA-4 inhibitor. Final approval is expected in the second half of the year. The first indication for Imfinzi and Imjudo combination therapy is liver cancer. The combination therapy is the only dual immunotherapy that has been approved for the first-line treatment of liver cancer and was approved by the US FDA in October last year as a treatment for unresectable hepatocellular carcinoma. In addition, it obtained marketing approval from Japan's Ministry of Health, Labor and Welfare in December last year and EMA in Europe in February. The combination therapy is a STRIDE (Single Tremelimumab Regular Interval Durvalumab) strategy in which Imfinzi is additionally administered at regular intervals every 4 weeks after administering 1500 mg of Imfinzi and 300 mg of Imjudo once. In the HIMALAYA study, a phase 3 clinical trial, the combination therapy reduced the risk of death by 22% compared to the control group, Nexavar monotherapy, and demonstrated OS benefit. The 3-year overall survival rate was 31% in the Imfinzi and Imjudo combination therapy group and 20% in the sorafenib monotherapy group. Imjudo combination therapy recently added indications for lung cancer in the United States. In the phase 3 clinical POSEIDON study, which served as the basis for approval, the patient group who received the Imfinzi/Imjudo/platinum-based chemotherapy combination showed a 23% lower risk of death compared to the various chemotherapy control groups. The 2-year overall survival rate was 33% in the combination group and 22% in the control group. Imjudo is conducting a phase 3 study of combination therapy with Imfinzi in several types of carcinoma, including the EMERALD-3 study, the ADRIATIC study, and the VOLGA and NILE studies.
- Company
- Reimb in progress for 1st endometrial cancer immunotherapy
- by Jung, Sae-Im May 30, 2023 05:33am
- Pic of Jemperli Will the latecomer cancer immunotherapy ‘Jemperli (dostarlimab)’ from GSK be reimbursed as the first cancer immunotherapy in endometrial cancer? With cancer immunotherapies changing the treatment paradigm for the first time in decades, the demand in the field to speed up the reimbursement progress has also been increasing. in the field. According to industry sources on the 30th, GSK has applied for the reimbursement of Jemperli to the Health Insurance Review and Assessment Service and is awaiting the application to be deliberated by the Cancer Disease Deliberation Committee. Therefore, whether the agenda will be deliberated by the CDDC is receiving attention. Jemperli is the 7th approved cancer immunotherapy in Korea. The drug received marketing authorization from the Ministry of Food and Drug Safety in December last year. The drug is a PD-1 inhibitor like Keytruda and Opdivo. Unlike the other PD-1 immunotherapies, Jemperli was first approved for use as a second-line treatment in patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy regimen who have a specific biomarker. The biomarker approved in the indication is ‘microsatellite instability-high or mismatch repair deficient (dMMR).' As a latecomer in the cancer immunotherapy market, Jemperli sought to clearly distinguish itself from the other drugs. Its strategy was to solidify its position in endometrial cancer, an area that has almost no existing immuno-oncology drugs in the market. In fact, only Keytruda among the existing cancer immunotherapy has indications for endometrial cancer. Jemperli entered as the second immuno-oncology drug in the field and started a one-on-one competition with Keytruda. Endometrial cancer is a cancer that occurs in the endometrium, which constitutes the inner wall of the uterus and accounts for the majority of cervical cancers. Approximately 1 out of 4 endometrial cancer patients are diagnosed in the advanced stage or experience recurrence, and there is no effective treatment available if the condition recurs after platinum-based chemotherapy. When using chemotherapy in the second line, the known average survival rate is less than 1 year, and the 5-year survival rate is only 10%. No new treatment has been introduced for relapsed or advanced endometrial cancer for around 30 years. The immunotherapies that have been introduced after decades have been evaluated to have transformed the endometrial cancer treatment paradigm. MSI-H/dMMR, which is considered a major biomarker for endometrial cancer treatment, is known to be present in up to 26% of patients. This is the highest among solid cancers. This means that the use of cancer immunotherapies can be relatively large in the area. Jemperli’s approval was based on the cohort A1 analysis results of Phase I multicohort GARNET trial that included a cohort of patients with relapsed or advanced dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. In particular, this study had the largest cohort among PD-1 inhibitor monotherapy studies for dMMR/MSI-H endometrial cancer patients among those that have been conducted so far. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% (95% CI, 34.0-53.4) and the median DOR was not yet reached. 83.7% of the patients that showed response continued treatment for over 2 years. Overall survival (OS) estimates at 12 months and 24 months were 73.3% and 60.5%, respectively. Patients did not reach the median OS even with a long-term follow-up of more than 2 years. Recently, a possibility had risen for expanding the use of cancer immunotherapies as a first-line treatment for recurrent and advanced endometrial cancer. In the first quarter of this year, Jemperli and Keytruda each announced clinical results showing that the drugs were effective when used in combination with chemotherapy in the first line. In the Phase III RUBY study, Jemperli lowered the risk of disease progression and death by 36% compared to the placebo group. This is significant as the trial included patients without MSI-H/dMMR biomarkers. In the MSI-H/dMMR patient group, the risk of disease progression and death decreased by 72%. Keytruda reduced the risk of disease progression and death by 70% in patients with MSI-H/dMMR in a clinical trial. With the performance of cancer immunotherapies gaining prominence and data to change the standard treatment, and chemotherapy, increasing, the demand for the reimbursement of cancer immunotherapies in clinical settings has also been rising. No cancer immunotherapy is currently approved for reimbursement in endometrial cancer yet. In the global market, cancer immunotherapy is already being reimbursed in five of the major A8 countries - the US, Germany, the UK, Switzerland, and Italy. Currently, only Jemperli has applied for reimbursement for endometrial cancer. However, an unmet demand exists as the agenda has not been presented for CDDC review for some while. Seob Jeon, Director of the Insurance Committee at the Korean Society of Gynecologic Oncology (Gynecology, Soonchunhyang University Cheonan), said, “The introduction of a new cancer immunotherapy option that can be used as monotherapy in recurrent endometrial cancer, an area that had a 5-year survival rate below 10%, has brought new hope to the patients. However, we need collaborative efforts from the government and pharmaceutical companies for the patients who are waiting for reimbursement for cancer immunotherapy because they have no other alternative than cytotoxic chemotherapy. I hope that the policy grounds will be laid so that the benefits of the treatment can be applied in the field."
