New immuno-oncology treatment approved for endometrial cancer
Posted: 1 August 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The first new treatment option approved for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer in decades has been authorised by the US Food and Drug Administration (FDA).
The only immuno-oncology treatment approved as frontline therapy for mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), primary advanced or recurrent endometrial cancer in combination with chemotherapy, is now authorised in the US. Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the US Food and Drug Administration (FDA).
The biologic is authorised for use in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for treating adults with dMMRMSI-H primary advanced or recurrent endometrial cancer.
“Today’s expanded approval of Jemperli redefines the treatment landscape” for these patients, according to Hesham Abdullah, Senior Vice President, Global Head of Oncology Development at GSK.
Positive data for the Jemperli immuno-oncology treatment
“In the RUBY trial, Jemperli plus chemotherapy demonstrated a 71 percent reduction in the risk of disease progression or death versus chemotherapy in this patient population, providing a statistically significant and clinically meaningful benefit,” shared Abdullah.
With this approval, Jemperli is now indicated earlier in treatment in combination with chemotherapy.
The FDA approval is supported by interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial.
The RUBY trial data were presented at the European Society for Medical Oncology (ESMO) Virtual Plenary and Society of Gynecologic Oncology (SGO) Annual Meeting on 27 March 2023, and were simultaneously published in The New England Journal of Medicine.
In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for adults with primary advanced or recurrent endometrial cancer that is dMMR. This is alongside as a single agent for adults with dMMR recurrent or advanced endometrial cancer, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
The supplemental Biologics License Application (sBLA) supporting the new indication in combination with carboplatin and paclitaxel received Breakthrough Therapy designation (BTD) from the FDA.
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