On August 1, 2024, the U.S. Food and Drug Administration (FDA) approved an expanded indication for dostarlimab-gxly (Jemperli), in combination with carboplatin and paclitaxel, for adult patients with primary advanced or recurrent endometrial cancer. This new approval allows the use of dostarlimab-gxly not only in mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) patients but also in the broader population of those with primary advanced or recurrent endometrial cancer.
Clinical Trial Evidence
The approval was based on the results of the RUBY trial (NCT03981796), a randomized, multicenter, double-blind, placebo-controlled study involving 494 patients. Participants were randomized to receive either dostarlimab-gxly with carboplatin and paclitaxel, followed by dostarlimab-gxly alone, or a placebo with the same chemotherapy regimen. The primary efficacy endpoints were progression-free survival (PFS) and overall survival (OS). The study demonstrated a statistically significant improvement in OS and PFS for patients treated with dostarlimab-gxly compared to the placebo group. Specifically, the median OS was 44.6 months for the dostarlimab-gxly group versus 28.2 months for the placebo group. The median PFS was 11.8 months compared to 7.9 months in the placebo group.
Safety Profile
The most common adverse reactions observed with the dostarlimab-gxly combination included anemia, increased creatinine, peripheral neuropathy, decreased white blood cell count, and fatigue. These findings are consistent with previously reported safety profiles for the drug. The treatment protocol involves an initial dosage of 500 mg of dostarlimab-gxly every three weeks for six cycles with carboplatin and paclitaxel, followed by 1,000 mg every six weeks as monotherapy until disease progression or unacceptable toxicity.
Regulatory and Expedited Review
This approval came through the FDA’s priority review and other expedited programs, underscoring the urgency and potential impact of this treatment option. The FDA’s decision was facilitated by the Assessment Aid, a voluntary submission by the applicant to streamline the review process. This application was approved three weeks ahead of the FDA’s goal date, reflecting the importance and effectiveness of dostarlimab-gxly in treating advanced endometrial cancer.
Conclusion
The expansion of the indication for dostarlimab-gxly represents a significant advancement in the treatment of endometrial cancer, offering new hope for patients with advanced or recurrent disease. The combination therapy not only improves survival rates but also provides a well-tolerated treatment option, expanding the arsenal of therapies available to oncologists.
For healthcare professionals, it is essential to report any serious adverse events associated with this treatment to the FDA’s MedWatch Reporting System. For further information on the prescribing details and safety, refer to the full prescribing information available on Drugs@FDA
Other Links from OncologyTube:
“AZUR-2: Dostarlimab vs. Standard Care in Resectable Colon Cancer”
This article discusses the global study AZUR-2, which explores the efficacy of dostarlimab as a monotherapy in treating resectable colon cancer. The study aims to evaluate the potential of perioperative dostarlimab to replace standard chemotherapy, potentially offering a more targeted and well-tolerated treatment approach.
Read more (OncologyTube).
Links from around the world:
The FDA has expanded the indication for dostarlimab-gxly (Jemperli) in combination with chemotherapy for the treatment of advanced or recurrent endometrial cancer. This approval, based on the results from the RUBY trial, includes patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors. The study demonstrated significant improvements in progression-free and overall survival, offering a new therapeutic option for this patient population.
Read more about the FDA’s expanded approval for dostarlimab-gxly in endometrial cancer.
“FDA Approves Dostarlimab-gxly with Chemotherapy for Endometrial Cancer”
This article details the FDA’s approval of dostarlimab-gxly in combination with chemotherapy for treating advanced or recurrent endometrial cancer. The approval is based on the RUBY trial, which demonstrated significant improvements in progression-free survival and overall survival for patients receiving this treatment.
Read more (ESMO).