FDA Approves Jemperli as Frontline Treatment for Advanced Endometrial Cancer

The FDA has approved GSK’s supplemental biologics license application (sBLA) for Jemperli (dostarlimab-gxly) in frontline treatment for patients with advanced or recurrent endometrial cancer, making it the first immune-oncology treatment for this patient population. Jemperli is indicated for patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) in combination with carboplatin and paclitaxel.

Jemperli is already approved in the United States as monotherapy in adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen.

Endometrial cancer is the most common gynecologic cancer globally, with about 417,000 new cases reported each year worldwide. About 15% to 20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis. Patients with advanced disease typically have poor outcomes.

Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody. The price of is about $11,712 per 500 mg/10 mL vial, which is initially given once every three weeks for four doses, according to Drugs.com. GSK offers co-pay assistance of up of $26,000 for patients with commercial insurance.

Wenora Johnson

“The endometrial cancer community is thrilled by today’s news, which changes the treatment paradigm for a population with long-term unmet needs,” Wenora Johnson, president, board of directors, Facing Our Risk of Cancer Empowered (FORCE), said in a press release.

The FDA approval is supported by interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial. In the dMMR/MSI-H population, treatment with Jemperli led to a 71% reduction in the risk of disease progression or death. The most common treatment-emergent adverse events (≥ 20%) were rash, diarrhea, hypothyroidism and hypertension.

The RUBY trial data were presented at the European Society for Medical Oncology (ESMO) Virtual Plenary and Society of Gynecologic Oncology (SGO) Annual Meeting in March 2023.