FDA Expands Approval of GSK’s Jemperli in Combination with Chemotherapy for Adults with Primary Advanced or Recurrent Endometrial Cancer

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The FDA has approved an expanded indication for GSK’s Jemperli (dostarlimab) to include treatment of all adults with primary advanced or recurrent endometrial cancer. According to the company, this is the first time that an immune-oncology regimen has demonstrated a survival benefit for this patient population. Additionally, the company stated that the approval expands the indication for Jemparli plus chemotherapy to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, which represents 70%-75% of patients diagnosed with endometrial cancer and has limited treatment options. The approval was based on positive results from Part 1 of the Phase III RUBY clinical trial.¹

“Jemperli plus chemotherapy is the first and only immuno-oncology regimen to show significant and meaningful improvement in overall survival for adult patients with primary advanced or recurrent endometrial cancer regardless of biomarker status. We are thrilled this option is now available for more patients in the US, including the 70%-75% with MMRp/MSS tumors where treatment options have been limited,” said Hesham Abdullah, SVP, global head oncology, R&D, GSK, in a press release.

The two-part global, randomized, double-blind, multicenter RUBY trial enrolled patients with primary advanced or recurrent endometrial cancer. In Part 1, investigators evaluated Jemperli plus carboplatin-paclitaxel followed by Jemperli versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 of the study is evaluating Jemperli plus carboplatin-paclitaxel followed by Jemperli plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo. Part 1 included histologies often excluded from clinical trials, such as 10% of patients with carcinosarcoma and 20% with serous carcinoma, according to the authors.

Results of the trial demonstrated a 31% reduction in the risk of death and a 16.4-month improvement in median overall survival compared to chemotherapy alone. Additionally, 61% of patients in the Jemperli plus chemotherapy group were still alive after 2.5 years compared to 49% in the chemotherapy group.

The safety profile of Jemperli plus chemotherapy was reported to be consistent with the known safety profiles of the individual agents. Common adverse events included nausea, alopecia, fatigue, peripheral neuropathy, anemia, arthralgia, constipation, diarrhea, myalgia, rash, hypomagnesemia, decreased appetite, peripheral sensory neuropathy, and vomiting.¹

“The initial approval of Jemperli plus chemotherapy was practice-changing for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer and today’s expanded approval will offer even more patients the opportunity for improved outcomes. This is the only immuno-oncology treatment regimen that has shown a statistically significant overall survival benefit for the full patient population, which is a meaningful step forward in treating this challenging cancer,” said Matthew Powell, MD, chief, division of gynecologic oncology Washington University School of Medicine, US principal investigator of the RUBY trial, in the press release.

According to GSK, an estimated 1.6 million people are currently living with active endometrial cancer worldwide, with approximately 17,000 new cases reported each year. By 2040, incidence rates are expected to rise 40%. Only 15% to 20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.¹

“With this expanded approval for Jemperli plus chemotherapy, GSK is bringing a much-needed new treatment regimen to the endometrial cancer community that may help patients with primary advanced or recurrent endometrial cancer live longer, providing hope to patients and their families. Survivors and advocates should be excited by today’s news and especially delighted that this approval means that more patients in the US who are diagnosed with endometrial cancer will have a new treatment option,” said Adrienne Moore, survivor, founding member, president, Endometrial Cancer Action Network for African Americans, in the press release.

Reference

1. US FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit. GSK. August 1, 2024. Accessed August 2, 2024. https://www.gsk.com/en-gb/media/press-releases/us-fda-expands-jemperli-dostarlimab-plus-chemotherapy-approval-to-all-adult-patients-with-primary-advanced-or-recurrent-endometrial-cancer/