FDA Approves Jemperli with Chemotherapy for Advanced/Recurrent Endometrial Cancer

August 01, 2024, GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has granted approval for Jemperli (dostarlimab-gxly) to be used in combination with carboplatin and paclitaxel (chemotherapy), followed by Jemperli as a standalone treatment for adult patients with primary advanced or recurrent endometrial cancer. This new approval expands the previous indication, now including patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors. These patients make up 70-75% of those diagnosed with endometrial cancer and typically have limited treatment options. The supplemental Biologics License Application (sBLA) for this expanded indication received Priority Review and was approved ahead of the Prescription Drug User Fee Act action date.

Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, described the combination of Jemperli plus chemotherapy as the first immuno-oncology regimen to demonstrate significant improvement in overall survival for adult patients with advanced or recurrent endometrial cancer, regardless of biomarker status. Abdullah expressed enthusiasm that this treatment option is now available for a broader patient population in the US.

The expanded approval is supported by results from the RUBY phase III trial, which reported dual primary endpoints of progression-free survival (PFS) and overall survival (OS). Part 1 of the RUBY trial is notable for being the only clinical trial to show a statistically significant improvement in OS for patients with primary advanced or recurrent endometrial cancer. The results demonstrated a 31% reduction in the risk of death compared to chemotherapy alone. At the 2.5-year mark, 61% of patients receiving Jemperli plus chemotherapy were alive compared to 49% in the chemotherapy group. Additionally, a median overall survival improvement of 16.4 months was observed with Jemperli plus chemotherapy versus chemotherapy alone. The median follow-up duration was over three years.

Safety and tolerability data from RUBY Part 1 indicated that the safety profile of Jemperli combined with carboplatin-paclitaxel was generally consistent with known profiles of the individual agents. Common treatment-emergent adverse events (≥20%) included nausea, alopecia, fatigue, peripheral neuropathy, anemia, arthralgia, constipation, diarrhea, myalgia, rash, hypomagnesemia, decreased appetite, peripheral sensory neuropathy, and vomiting.

Dr. Matthew Powell, Chief of the Division of Gynecologic Oncology at Washington University School of Medicine and the US principal investigator of the RUBY trial, highlighted that the initial approval of Jemperli plus chemotherapy was transformative for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. The expanded approval extends this benefit to a broader patient population.

Adrienne Moore, a survivor and president of the Endometrial Cancer Action Network for African-Americans (ECANA), expressed optimism that the expanded approval of Jemperli plus chemotherapy would provide a much-needed treatment regimen. She emphasized that this development offers hope to patients and their families, potentially improving survival outcomes for those diagnosed with primary advanced or recurrent endometrial cancer.

Endometrial cancer is the most common gynecologic cancer in developed countries, with 1.6 million people living with the disease and 417,000 new cases reported globally each year. The incidence rate is expected to increase by 40% between 2020 and 2040. Approximately 15-20% of patients are diagnosed with advanced disease, and 70-75% of these patients have MMRp/MSS tumors.

The RUBY trial is a global, randomized, double-blind, multi-center phase III study evaluating dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-gxly versus carboplatin-paclitaxel plus placebo followed by placebo. Part 1 focused on primary endpoints of PFS and OS, while Part 2 is assessing additional endpoints. The trial includes a comprehensive patient population and involves exploratory analyses of different tumor types.

Jemperli (dostarlimab-gxly) is a PD-1-blocking antibody and a key component of GSK's immuno-oncology research and development program. It was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., with GSK responsible for its ongoing development and commercialization. 

GSK aims to maximize patient survival through breakthroughs in immuno-oncology and tumor-cell targeting therapies, with a focus on hematologic malignancies, gynecologic cancers, and other solid tumors.

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