![]() Those patients showed disease progression during or after plastic-based systemic chemotherapy during multiple-cohort GARNET phase 1 clinical trial for recurrent or progressive solid cancer patients. Jemperli’s approval was made based on the analysis of cohort A1 where recurrent or progressive dMMR/MSI-H endometrial cancer patients are registered. Afterward, it is administered in 1,000mg dose every six weeks if the disease progresses or expresses severe toxicity. Jemperli is given once every three weeks for four cycles as 500mg intravenous injections. It was the third PD-1 inhibitor (immunosuppressor) that won domestic approval as monotherapy for adult patients with recurrent and progressive dMMR/MSI-H endometrial cancer with confirmed progression during or after platinum-based systemic therapy. Jemperli won regulatory approval in December last year. The incidence of significant adverse reactions (≥3 percent) in the Kitruda-Lenbatinib combination group was reported to be 50 percent, including hypertension (4.4 percent) and urinary tract infection (3.2 percent). The median value of overall survival (mOS) was 17.4 months for the Keytruda-Lenvima group and 12 months for the chemotherapy group, and the median value of progression-free survival (mPFS) was 6.6 months vs. The study confirmed the efficacy and safety of Keytruda-Lenvima combo therapy in treating progressive endometrial cancer patients who have received at least one platinum-based chemotherapy of all treatments, including preoperative and postoperative adjuvant therapy.Īs a result of the study, the Keytruda-Lenvima combo therapy confirmed statistically significant improvement in overall survival (OS) and progression-free survival (PFS) by reducing death risk by 32 percent compared to chemotherapy (doxorubicin or paclitaxel) and lowering progression or death risk by 40 percent. In addition, the ministry gave final approval based on the phase 3 clinical trial of the KEYNOTE-775 study. ![]() The combination therapy received (incomplete) approval from the ministry based on KEYNOTE-146/Study 111), a phase clinical trial, in May 2020. The ministry approved the combination therapy of Keytruda and Lenviama (lenvatinib) to treat progressive endometrial cancer patients with confirmed progression after previous systemic therapy and without microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Keytruda got ahead of Jemperli in obtaining an indication for solenoma by getting a nod from the Ministry of Food and Drug Safety in December 2021. Jemperli has completed applying for insurance coverage, and Keytruda is preparing documents to do so. ![]() GSK’s Jemperli (dostalimab) and MSD’s Keytruda (pembrolizumab) ![]()
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