On Monday, the European Commission approved GSK plc’s (NYSE:GSK) Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.

The approval broadens the previous indication for Jemperli plus chemotherapy in the European Union (EU) to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, which represent approximately 75% of patients diagnosed with endometrial cancer and who have limited treatment options.

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The European Commission’s approval to expand the use of Jemperli plus chemotherapy is based on results from Part 1 of the RUBY phase 3 trial.

The company says RUBY Part 1 is the only clinical trial in this setting to show a clinically meaningful and statistically significant overall survival benefit in the full population of patients with primary advanced or recurrent endometrial cancer, showing a 31% reduction in risk of death compared to chemotherapy alone.

At the 2.5-year landmark, the chance of being alive was 61% for the Jemperli plus chemotherapy group (245 patients) compared to 49% in the chemotherapy group (249 patients).

In addition, a 16.4-month improvement in median OS was observed with Jemperli plus chemotherapy versus chemotherapy alone. The median duration of follow-up was more than three years.

The safety and tolerability analysis from RUBY Part 1 showed a safety profile for Jemperli plus carboplatin-paclitaxel that was generally consistent with the known safety profiles of the individual agents.

The label for Jemperli plus chemotherapy in the U.S. was expanded to all adult patients with primary advanced or recurrent endometrial cancer in August 2024.

Recently, GSK agreed to acquire IDRx, Inc., a biopharmaceutical company focused on precision therapeutics for gastrointestinal stromal tumors, for $1 billion.

Price Action: GSK stock is up 0.76% at $33.69 at last check Tuesday.

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This article Europe Drug Regulator Expands GSK's Jemperli/Chemo Combo To Adult Patients With Advanced Endometrial Cancer originally appeared on Benzinga.com

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