GSK’s Jemperli (dostarlimab) has been recommended by the European Medicines Agency’s human medicines committee to treat a broader range of endometrial cancer patients.
The Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approval of the drug in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of all adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.
This would include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, who represent up to 75% of those diagnosed with the disease and are not currently covered by the drug’s EU label.
Endometrial cancer, found in the inner lining of the uterus, is the most common gynaecological cancer in developed countries, with approximately 121,000 people diagnosed with primary advanced or recurrent cases of the disease each year in Europe.
Jemperli is a PD-1-blocking antibody that is designed to help the body’s immune system find and attack cancer cells. The drug is already approved in the EU in combination with carboplatin and paclitaxel and as a monotherapy to treat certain adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer.
The CHMP’s new recommendation is based on positive results from part one of the late-stage RUBY trial, which met its dual primary endpoints of investigator-assessed progression-free survival and overall survival, demonstrating a statistically significant and clinically meaningful benefit in the full population of patients treated with Jemperli plus carboplatin-paclitaxel versus chemotherapy alone.
The European Commission will now consider the CHMP’s opinion as it makes a decision on Jemperli in this expanded indication.
The recommendation follows the US Food and Drug Administration’s approval of Jemperli for all adult patients with primary advanced or recurrent endometrial cancer in August.
US principal investigator of the RUBY trial, Matthew Powell, Washington University School of Medicine, said at the time of the authorisation: “The initial approval of Jemperli plus chemotherapy was practice-changing for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer and [the] expanded approval will offer even more patients the opportunity for improved outcomes.”
Jemperli was also recommended by the National Institute for Health and Care Excellence in combination with platinum-containing chemotherapy for certain adults with dMMR/MSI-H endometrial cancer earlier this year.