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- 2026-04-08 22:18:32
- Policy
- First Depakote generic is being reviewed for reimb in KOR
- by Lee, Tak-Sun Dec 08, 2023 05:55am
- The first generic of Abbot Korea’s epilepsy drug ‘Depakote ER Tab’ is undergoing a reimbursement process in Korea. The drug is ‘Divalpro ER Tab 500mg,’ developed by Korea Pharma. The drug was first approved in Korea on November 8th. It is the first generic drug to contain divalproex sodium, the main active ingredient of Depakote ER. Depakote ER was approved in Korea in 2002. It was approved in two dosage forms, and the drug posted sales of KRW 10 billion in 2022 according to IQVIA. With no patents listed on the MFDS’s green list, there were no obstacles to the approval or release of its generic versions. However, due to difficulties in bioequivalence testing, only a few companies, including Korea Pharma, WhanIn Pharma, and Mirae Pharm, had been reportedly developing its generics. In the field, Korea Pharma became the first to receive marketing authorization and seize the first generic status in Korea, making a head start in the development race. The company applied for reimbursement immediately after receiving approval. As a result, HIRA has been reviewing whether Korea Pharma’s generic drug satisfies the reimbursement conditions as part of its drug pricing calculation process. The insurance ceiling price of the original drug, Depakote ER 500mg, is currently KRW 391. If Divalpro ER satisfies both requirements – directly completing bioequivalence tests and using a substance registered in the DMF – its price will be set at 53.55% of the price the original drug received before patent expiry. In Korea, generic drugs usually take 3 months from reimbursement to listing, so it is expected that the drug will be listed for reimbursement in February next year, after which the company will conduct full-scale marketing activities. The introduction of reimbursed generics means that the prescribing options will be expanded in the field. The drug is indicated as monotherapy and adjunctive therapy in complex partial seizures in adults and pediatric patients down to the age of 10 years, and in simple and complex absence seizures.
- Company
- Former Janssen Korea President Cherry Huang goes to China
- by Eo, Yun-Ho Dec 08, 2023 05:55am
- Cherry Huang, former President of Janssen Korea It has been confirmed that the position of President at Janssen Korea is currently vacant. According to Dailypharm's coverage, former CEO Cherry Huang recently left the company to serve as President of the Chinese subsidiary. As a result, Janssen Korea is now in the search for a new president. Since being appointed president in May 2021, Huang has led Janssen Korea for more than 2 years. She was the second foreign lead to head the Korean subsidiary, following her predecessor Jenny Chung. Since appointing Jung-Hoon Jang as president in 1983, the company has appointed Koreans to head the subsidiary, appointing Tae-Hong Choi, the current CEO of Hana Pharm in 2007, then Sangjin Kim, current President/Co-CEO at Samil Pharmaceutical, in 2011, then Oak-yeon Kim in 2012. In 2018, the company switched to a foreign president when Oak-yeon Kim transferred to the Asia-Pacific division. Whether Janssen Korea will switch back to a local leader remains to be seen. Meanwhile, Johnson & Johnson's pharmaceutical division, Janssen Korea, was a powerhouse in the central nervous system (CNS) field until the early 2000s. Currently, the company has established a reputation for itself in the autoimmune disease space, after entering the market with ‘Remicade (infliximab),’ and has been offering a variety of treatment options including ‘Stelara (ustekinumab),’ ‘Tremfya (guselkumab),’ and ‘Simponi (golimumab).’
- Company
- Jemperli reimbursed as immunotherapy for endometrial cancer
- by Dec 08, 2023 05:55am
- GSK Korea holds a press conference celebrating the launch of its immunotherapy Jemperli’s reimbursement A new immuno-oncology drug has been added to the sparse list of treatments available for endometrial cancer. GSK Korea succeeded in obtaining insurance reimbursement for its Jemperli in a year since obtaining approval in Korea in December last year. GSK Korea held a press conference on Sunday at Lotte Hotel Seoul to celebrate the launch of its immuno-oncology drug Jemperli (dostarlimab) in Korea. The drug is a PD-1 inhibitor class immuno-oncology drug. It was approved in Korea as a treatment for patients with recurrent or advanced deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) endometrial cancer that has progressed on or following prior systemic treatment with a platinum-containing chemotherapy regimen who are in December last year. The drug was approved for reimbursement in 1 year since then. Jemperli has been listed on the reimbursement list as of December 1. Jemerli demonstrated efficacy in the GARNET trial that enrolled 143 patients with recurrent or advanced dMMR/MSI-H endometrial cancer. After a median follow-up period of 27.6 months, Jemperli achieved an objective response rate (ORR) of 45.5%. The complete response rate was 16.1%, and the partial response rate was 29.4%. Among patients who showed treatment response, 93.3% and 83.7% of the patients showed continued treatment response at 12 months and 24 months, respectively. Most of the reported adverse events were mild, and included diarrhea (16.3%), asthenia (15.7%), and fatigue (13.7%). Jae-Weon Kim, Professor of Obstetrics and Gynecology at Seoul National University Hospital, said, “A limitation existed in the field due to lack of treatments available for use in case of recurrence after platinum-based chemotherapy. Jemperli’s reimbursement holds significance as being the first immuno-oncology drug to be granted reimbursement in the field.” Jemperli attempts to expand its reimbursement as first-line therapy in endometrial cancer… an area that lacks treatment options At the conference, GSK also indicated the possibility of extending Jemperli’s marketing authorization to the first line in endometrial cancer. Currently, the 5-year survival rate for recurrent endometrial cancer is reported to be less than 20%. For recurrent patients who have failed first-line treatment, the survival rate falls further to less than 1 year. The current first-line standard of care for endometrial cancer was the cytotoxic agent combination of paclitaxel and carboplatin. Second-line treatment options are even more limited. Old drugs such as paclitaxel, Avastin (bevacizumab), and docetaxel are being used as second-line treatment, but have not had a significant impact on improving survival. Therefore, the company plans to expand Jemperli’s indication to the first line in endometrial cancer based on its clinical results while seeking approval for other cancers. Yoo-jin Yang, managing director of GSK Korea’s Oncology BU, said, “We are working to secure more indications for Jemperli in other areas, in addition to endometrial cancer. In endometrial cancer, we will work to receive approval for Jemperli as a first-line treatment."
- Company
- JW Pharm Hemlibra's sales tops KRW 10 bil for the 1st time
- by Chon, Seung-Hyun Dec 07, 2023 05:47am
- Annual sales of JW Pharmaceutical's Hemlibra has surpassed the 10 billion won mark for the first time since its launch in Korea. The expanded reimbursement significantly boosted sales, by threefold. According to the pharmaceutical research agency IQVIA, Hemlibra's Q3 sales reached 6.8 billion won, a 261.3% increase from 1.9 billion won in the same period last year. Hemlibra is a prophylactic treatment for Type A hemophilia, which is caused by the deficiency of blood clotting Factor VIII. It utilizes a dual-specific antibody technology that binds simultaneously to clotting Factors IX and X. Unlike traditional Factor VIII treatments, Hemlibra is the first non-Factor VIII medication that can be administered subcutaneously at intervals of up to four weeks. Hemlibra was developed by Chugai Pharmaceutical, a subsidiary of Roche. JW Pharmaceutical secured the domestic development and sales rights for Hemlibra in 2017 and received approval from the Ministry of Food and Drug Safety in 2019. Hemlibra had been released with reimbursement in 2020, and its sales remained at mere 2.1 billion won range in Q1. However, its sales rose to 3.6 billion won in Q2, up by 68.4% from the previous quarter, and showed an even steeper increase in Q3. The surge in Hemlibra's Q2 sales was due to the expanded reimbursement. Since May, Hemlibra has been reimbursed for patients over the age of one with Type A hemophilia who do not have Factor VIII antibodies. In May 2020, Hemlibra was initially reimbursed for severe Type A hemophilia patients with inhibitors. Three years later, the reimbursement was expanded to non-antibody patients. JW Pharmaceutical reports that there are approximately 1,700 Type A hemophilia patients in Korea, with about 70% being severe cases. Among them, a significant majority are non-antibody patients. Over 60% of Type A hemophilia patients in Korea fall under Hemlibra reimbursement group. Hemlibra's sales last year reached 7.6 billion won. The quarterly sales alone nearly matched the previous year's annual sales, marking significant growth due to the reimbursement expansion. For the first time since its launch in Korea, Hemlibra topped the annual sales of 10 billion won, amounting to 12.5 billion won in Q3 sales. JW Pharmaceutical expects Hemlibra to provide substantial treatment benefits to patients based on its efficacy and safety proven through large-scale clinical trials. In the HAVEN 1 trial that was conducted on patients with inhibitors, Hemlibra showed a 79% reduction in annualized bleeding rate (ABR) to 3.3 compared to prior prophylaxis with a bypassing agent. or patients without inhibitors, the HAVEN3 trial demonstrated a 68% reduction in ABR to 1.5 compared to factor VIII prophylaxis. Research comparing the effects of Hemlibra on both inhibitor and non-inhibitor patients yielded similar results and confirmed long-term efficacy. The goal of prophylaxis (bypassing therapy) for hemophilia patients is to maintain a certain level of factor VIII activity to prevent bleeds. Hemlibra has shown sustained plasma concentrations. According to the company, the clinical trial demonstrated a favorable safety profile. Results from HAVEN 1 - 4 trials had shown that side-effects observed in patients treated with Hemlibra were minor injection site reactions. Hemlibra’s global sales last year were 3.823 billion Swiss francs (approx. 5.7 trillion won), up 27% from the 3.022 billion Swiss francs YoY. Currently, over 20,000 patients in 144 countries worldwide are using Hemlibra.
- Opinion
- [Reporter’s View] CSO is a double-edged sword
- by Kim, Jin-Gu Dec 07, 2023 05:47am
- Over the past few years, small mid-sized pharmaceutical companies and contract sales organizations (CSOS) have developed a strong symbiotic relationship. Small and mid-sized pharmaceutical companies have provided work for CSOs, and CSOs have repaid the companies by improving their performance. Due to this, many companies, especially small- and mid-sized companies, have partnered with CSOs. Over the past few years, CSOs have become "the trend" for small- and mid-sized pharma companies, as their performance varied depending on whether they used CSOs. Also, CSOs have expanded their role by specializing in sales for specific products or regions. They have been praised for improving cost-effectiveness and profitability through flexible sales activities, but they have also been criticized that it has become a ‘breeding ground for rebates.’ It was constantly pointed out that CSOs were being utilized as a rebate delivery channel, hiding in the blind spots of the system. Then, the CSO Reporting System emerged to address this issue. A bill to amend the Pharmaceutical Affairs Act to require CSOs to report to the government and local governments passed the National Assembly in the first half of this year. The revised Pharmaceutical Affairs Act will come into effect on October 19 next year Once implemented, the government will be able to hold pharmaceutical companies that signed contract sales agreements with CSOs accountable for the CSO’s deviant activities. This means when rebates are made, not only the CSO but also the pharmaceutical company involved could be criminally punished as an "accomplice". Even if the company avoids criminal penalties, it will be difficult to avoid administrative penalties because criminal penalties and administrative penalties are imposed separately. The administrative penalty imposed on a Korean pharmaceutical company that was finalized in July this year is a good example. Although the company was acquitted by the prosecution due to insufficient evidence for the rebate case that was discovered in 2016, the Supreme Court made the final ruling to impose a 3-month suspension on the sales of 14 items. Therefore, cases of rebates made through CSOs may also be judged similarly. Even if the companies avoid criminal penalties, they may still face strong administrative penalties. Moreover, if multiple rebate cases are found at the same time, the administrative penalties may be accrued or raised. For small- and mid-sized pharmaceutical companies, such rulings will be a hard blow. In this sense, CSOs are now a double-edged sword for small- and mid-sized pharmaceutical companies. They can improve performance but the companies will have to also bear the risk. The time has come for pharmaceutical companies that have already built a symbiotic relationship with CSOs to make a choice. Will the companies continue to work with CSOs that deliver high performance, or reduce the role of CSOs to mitigate risk? The companies will need to make their decision quickly, as just over 10 months remain until the CSO reporting system comes into effect.
- Company
- Bemarituzumab is granted ODD status in Korea
- by Eo, Yun-Ho Dec 07, 2023 05:47am
- The new gastric cancer drug bemarituzumab received an orphan drug status in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced so through the orphan drug designation notice. Specifically, the drug is indicated to treat patients with fibroblast growth factor receptor 2b (FGFR2b) overexpression and unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma. Amgen’s bemarituzumab is a first-in-class investigational FGFR2b targeted antibody. And, Amgen gained access to the drug as part of its acquisition of Five Prime Therapeutics in 2021. In the same year, the FDA has granted bermarituzumab a Breakthrough Therapy designation (BTD). Bermarituzumab is a humanized IgG1 monoclonal antibody that targets the binding of FGFR2b. It blocks FGFR2b activation and slows cancer progression. The data from the its Phase 2 FIGHT clinical trial was been released in October 2022. For patients with HER2-negative FGFR2b-overexpressing tumor, bemarituzumab plus combination chemotherapy demonstrated clinically significant results in progression free survival (9.5 months vs 7.4 months), overall survival (19.2 months vs 13.5 months), and response rate (53% vs 40%). Based on the previous results, the company has been conducting FORTITUDE-101 and FORTITUDE-102 Phase 3 trials to further evaluate bemarituzumab in FGFR2b overexpression gastric cancer patients. In the Phase 1 trial, bemarituzumab showed no dose-limiting toxicities and a had confirmed objective response rate (ORR) of 18% in patients with refractory FGFR2b-positive gastric cancer.
- Company
- Dong-A and Pfizer win Industry Ad-PR Awards
- by Kim, Jin-Gu Dec 07, 2023 05:47am
- Dong-A Pharmaceutical's ‘Bacchus’ and Pfizer Korea's 'Green Move Campaign' won the grand award in the advertising and PR categories of the 2023 Korea Pharmaceutical and Bio-Industry Advertising and PR Awards. On the 6th, Dailypharm (CEO: Jeong Seok Lee) held the ‘2023 Korea Pharmaceutical and Bio-Industry Advertising and PR Awards Ceremony’ at the K-room of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association heqdquarters. Now celebrating its 11th year, the competition for the award had been stronger than ever, with 77 entries from 39 pharmaceutical companies. The awards were divided into advertising and PR categories. In the advertising category, 1 grand prize, 1 best excellence prize, and 1-3 excellence prizes were given in each of the 3 areas: ▲TV-CF, ▲print-radio, and ▲Internet-SNS. In the PR category, one grand prize, 1 best excellence prize, and 2 excellence prizes were awarded given in 2 areas: ▲social contribution and disease promotion campaigns, and ▲corporate and product promotion. Dong-A Pharmaceutical's ‘Bacchus’ seized the grand prize in the advertisement category. Among the 49 entries that were made in the category, Dong-A’s advertisement received the highest scores for message clarity, novelty, and consumer trust. The grand prize awardee received a trophy and a cash prize of KRW 5 million. Sang-Hyun Han, Advertisement Team Lead at Dong-A Pharmaceutical, said, “This year marks the 60th anniversary of Bacchus’s launch. We prepared an ad that looked back on the past 60 years of Korea with Bacchus and is pleased that our ad received good reviews as a result.” Han said, “We plan to release a more youthful and dynamic ad next year that celebrates Bacchus’s 60 years to come. We are planning an innovative and fresh advertisement that can lift the public's fatigue like our product.” In the TV-CF field, Dong Wha Pharm’s ‘Pancol’ received the best excellence prize, and was awarded a trophy and a cash prize of KRW 3 million. Boryung Consumer Healthcare’s ‘Younggaksan Cool,’ Johnson & Johnson Korea’s ‘Tylenol,’ and Samjin Pharm’s ‘Anjung Sol’ received excellence prizes and a cash prize of KRW 2 million. In the Internet and SNS field, Yuhan Corp’s ‘Contac Gold’ received the best excellence prize. Ahn-gook Pharm’s ‘Tobicom’ and Daewon Pharm’s ‘Newbein’ received excellence prizes. In the Print-Radio field, Daewoong Pharmaceuticals ‘Impactamin’ received the best excellence prize, and Kukje Pharm’s ‘Company PR ad’ received the excellence prize. In the PR category, 28 entries on the company’s CSR activities and company promotion were submitted by companies. Among the 28, Pfizer won the grand prize in the PR category with its ‘Green Move Campaign.’ As the grand prize awardee, Pfizer received a trophy and a cash prize of KRW 5 million. Oh Hye-min, Policy & Public Affairs Lead at Pfizer Korea, said, “Corporate ESG activities are no longer an option – it is an obligation. As our company is already engaged in various ESG activities at the headquarters level, we decided to start the Green Move campaign after long discussions on what Pfizer Korea could additionally provide to society. We want to make it a mid-to-long-term project rather than just a one-time event. We look forward to your interest." In the CSR and disease awareness campaign, area Sinsin Pharm’s ‘Shinshin H2O Life’ won the best excellence prize. The runners-up were Withus Pharmaceutical's ‘Sponsorship of the Korea Ssireum Association’ and Korea United Pharm’s ‘Global Talent Development Program.’ In Company PR and product promotion area, Hanmi Pharm’s ‘50th Anniversary History Discovery Campaign’ won the best excellence prize, while Geo-Young’s " Zyrtec 10mg for Allergic Rhinitis" and Boehringer Ingelheim's ‘Trajenta’ received excellence prizes. Dae-Chun Ahn, former president of the Korea Advertising Society (Inha University) served as the head of the judging panel for this year’s event, and Jae-Hoon Cheong, professor of Pharmacy at Sahmyook University, and Jae-Kook Lee, executive director of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association served as expert judges. Ahn said, "In the Advertising category, the judges focused on the delivery and clarity of the theme and message, how novel and original the ideas and expressions were, and how credible the message was beneficial to the consumers’ public interests." He added, "In the corporate PR category, we focused on how timely the message was from a long-term perspective and how it contributed to the consumers’ public interest. For CSR activities, an area that was newly introduced this year, we focused on the authenticity of the message, the degree of reflection into society, and the continuity and consistency of the campaign activities." The Korea Pharma & Bio Industry Advertising-PR Award was launched in 2013 to encourage advertisers to add new value to the pharmaceutical industry and drugs, and to encourage the creation of advertisements that resonate with pharmacists, the primary consumers of pharmaceutical advertisements." Jeong Seok Lee, CEO of Dailypharm, said, "I would like to congratulate the 17 pharmaceutical company officials that won today's awards. The awards are one recognition of the hard promoting and marketing work and efforts companies made throughout the year. We look forward to seeing more great work next year."
- Policy
- HIRA’s reimb reevaluation results to be released on the 7th
- by Lee, Tak-Sun Dec 07, 2023 05:47am
- The final results of the 2023 reimbursement adequacy reevaluations will be released on the 7th. On the day, the Health Insurance Review and Assessment Service’s Drug Reimbursement Evolution Committee will deliberate on the final reevaluation results that reflect the appeals made by pharmaceutical companies on the first results. In general, the pharmaceutical industry is not expecting the results to differ greatly from the first results, given the lack of appeals that were filed. However, in the case of hyaluronic acid eye drops, the committee discussed revising the reimbursement standards regarding the use amount after releasing the initial results, so industry eyes are on whether DREC will make a final decision on this on the 7th. The initial results announced at the end of DREC’s September 6 meeting concluded that rebamipid and levosulfiride were reimbursable. However, limaprostalpha-dex for improving ischemic symptoms of Berger's disease, such as ulcers, arterial pain, and coldness, was not considered to be adequate for reimbursement. Also, loxoprofen’s use to reduce fever and pain related to acute upper respiratory tract infection was not considered to be adequate for reimbursement. In the case of hyaluronic acid eye drops, which attracted the most attention, the committee deemed reimbursement inadequate for its use for exogenous diseases caused by surgery, drugs, trauma, or contact lens wear. Although its use for endogenous diseases such as Sjögren's syndrome, mucocutaneous ocular syndrome, and dry eye syndrome were deemed adequate, the committee determined that its reimbursement standards such as the number of prescriptions per patient visit and the total number of prescriptions per patient per year would need to be established for its appropriate use. The industry generally expressed pleasure about the initial results because the indications that were deemed non-reimbursable were not the drugs’ primary indications. However, as antipyretic and analgesic indications for loxoprofen have been heavily used during the COVID-19 pandemic, there was some pushback regarding its non-reimbursement in the medical community. In the case of the hyaluronic acid eye drops, there were fewer appeals from pharmaceutical companies because s its use for exogenous diseases is relatively low. The approved use for endogenous diseases accounts for the absolute majority of hyaluronic acid eye drop prescriptions, with over an 80% share. However, the industry is keeping a keen eye on restrictions that may be made on its use volume. Although there has been an opinion that its annual use should be restricted to 60 eyedrops (4 boxes), it has been reported that the committee had difficulty coming up with a unified plan due to strong opposition from the medical community and the pharmaceutical industry. Nevertheless, the industry prospects are that HIRA will report the results of its discussion to DREC to make a final decision. However, it is unlikely that DREC will come to an easy conclusion, therefore the reimbursement standards for restricting the volume is likely to be discussed beyond the year, according to industry analysis. If revisions to the reimbursement standards are postponed for this reason, it is expected that sodium hyaluronate eye drops’ reimbursement standards for exogenous diseases will first be removed and be granted reimbursement use only for endogenous diseases from January next year. An industry official said, "In the case of sodium hyaluronate eye drops, restricting its usage may greatly affect performance. We are waiting to see what decision DREC will make on this tomorrow."
- Policy
- Bill proposed to prioritize domestic drugs and vaccines
- by Lee, Jeong-Hwan Dec 06, 2023 06:00am
- A bill has been presented to prioritize purchases and use of domestic drugs and vaccines when Korea's national and local governments conduct drug stockpiling and National Immunization Programs (NIP). The bill also contains a provision to strengthen Korea's pharmaceutical sovereignty, including a plan to promote self-sufficiency of drugs in the Comprehensive Plan for Pharmaceutical Industry Development and Support. On April 24, Rep. Young-hee Choi, a member of the People Power Party presented a bill as representative to partially amend the Special Act on Fostering and Supporting the Pharmaceutical Industry. The current law requires the Minister of Health and Welfare to establish a Comprehensive Plan for Pharmaceutical Industry Development and Support every 5 years, which includes mid-to-long-term goals for fostering the pharmaceutical industry, to create a basis for industry development and strengthen its international competitiveness. However, the need to strengthen Korea’s drug sovereignty to enable domestic companies to develop and produce vaccines and essential medicines independently to overcome public health crises such as COVID-19 has been constantly raised since the COVID-19 outbreak. As competition among countries to foster the pharmaceutical industry is intensifying, the argument is that Korea also needs a policy to firmly establish its pharmaceutical sovereignty and rise to become a pharmaceutical powerhouse. For this, the revision presented by Rep. Choi includes amendments to provide grounds for the national government and local governments to prioritize the purchase of domestically produced drugs when conducting drug stockpiling or for Korea’s National Immunization Program (NIP), and to include a plan that can promote self-sufficiency of drugs in the contents of the Comprehensive Plan for Pharmaceutical Industry Development and Support. Rep. Choi said, "The Yoon Suk-yeol government has set the goal of making Korea one of the Top 6 global pharmaceutical and bio-pharma powerhouses by 2027. In the post-COVID-19 era, where the world is pursuing a “My nation first” policy for medicines, we hope that Korea will be able to achieve pharmaceutical sovereignty and emerge as a pharmaceutical and bio-pharma powerhouse by increasing the self-sufficiency rate of medicines.”
- Company
- Jemperli becomes 1st immunotherapy for endometrial cancer
- by Eo, Yun-Ho Dec 06, 2023 06:00am
- The first reimbursed immunotherapy option has been introduced to the field of endometrial cancer in Korea. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has been listed for reimbursement in Korea from December 1st. Since receiving marketing authorization from the Ministry of Food and Drug Safety in December last year, the company moved relatively quickly through the reimbursement process, passing HIRA’s Drug Reimbursement Evaluation Committee deliberation in August, and recently completed drug price negotiations with the NHIS and received approval from the Health Insurance Policy Review Committee. GSK has been carrying out an Expanded Access Program (EAP) in 15 major medical institutions in Korea even before filing for reimbursement to provide access to patients in need of treatment for endometrial cancer. The program has now been closed and Jemperli is being reimbursed through the NHIS as of this month. Jemperli’s approval was based on the cohort A1 analysis results of the Phase I multicohort GARNET trial that demonstrated the efficacy of Jemperli in 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. The major efficacy outcome measures of the study were Objective Response Rate (ORR) and Duration Of Response (DOR) as determined by a Blinded Independent Central Review (BICR) according to (Response Evaluation Criteria Solid Tumors) RECIST v 1.1. 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. Disease Control Rate (DCR) was 55.6%, and the proportions of responses lasting 6 and 12 months were 97.9% and 90.9%, respectively. Endometrial cancer develops in the endometrium, the inner lining of the uterus, and accounts for the majority of cervical cancer. Roughly, 1 out of 4 endometrial cancer patients are diagnosed to be in the advanced stage or experience recurrence, and patients whose disease recurs after platinum-based chemotherapy have limited treatment options.
