GSK Korea said Tuesday that its immunotherapy drug Jemperli (dostarlimab) has received expanded approval from the Ministry of Food and Drug Safety (MFDS).
The new indication allows Jemperli, in combination with platinum-based chemotherapy, to be used as a first-line treatment for all patients with advanced or recurrent endometrial cancer, regardless of mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) status.
Jemperli (dostarlimab) (Courtesy of GSK Korea)
The approval is based on results from the global, randomized, double-blind phase 3 RUBY trial, which evaluated 494 patients with advanced or recurrent endometrial cancer.
The study compared Jemperli combined with platinum-based chemotherapy (carboplatin and paclitaxel) to a placebo plus chemotherapy. At a median follow-up of 37 months, the trial showed that Jemperli reduced the risk of death by 31 percent (HR = 0.69; 95% CI, 0.54–0.89) in the overall population. Median overall survival improved by 16.4 months, reaching 44.6 months with Jemperli versus 28.2 months in the control group.
Safety findings were consistent with previous analyses, with the most common treatment-related side effects being fatigue, alopecia, and nausea, generally mild to moderate in severity.
Professor Lee Jae-kwan of Korea University Guro Hospital and president of the Korean Society of Gynecologic Oncology (KSGO) emphasized the need for effective first-line treatments in endometrial cancer, stating, “Endometrial cancer has a high risk of recurrence even after initial treatment.” He noted that Jemperli, when combined with platinum-based chemotherapy, is currently the only immunotherapy in Korea for endometrial cancer shown to improve overall survival.
Jemperli, a human IgG4 monoclonal antibody and PD-1 inhibitor, was initially approved by the MFDS in December 2022 for recurrent or advanced dMMR/MSI-H endometrial cancer after prior chemotherapy. Following reimbursement approval in March 2024, its use was expanded to include first-line treatment in dMMR/MSI-H cases. The latest approval extends its indication to all advanced or recurrent endometrial cancer patients for first-line treatment.
In response to these developments, the KSGO recently updated its clinical guidelines to include immune checkpoint inhibitors like Jemperli as first-line treatments for advanced or recurrent endometrial cancer, as well as in subsequent treatment lines for suitable patients.