GSK Reports Mixed Results for Jemperli/Zejula Combination in First-Line Ovarian Cancer Trial

Trial Outcome:
The Phase III FIRST-ENGOT-OV44 trial of the Jemperli (dostarlimab) and Zejula (niraparib) combination in first-line advanced ovarian cancer met its primary endpoint of progression-free survival (PFS)23.

Mixed Results:
Despite achieving the primary endpoint, the combination missed on a key secondary endpoint of overall survival (OS)34.

Clinical Significance:
The trial demonstrated a statistically significant improvement in PFS when dostarlimab is added to standard chemotherapy and niraparib maintenance, offering potential benefits for patients with advanced ovarian cancer2.

Development Context:
This study is part of GSK’s broader efforts in gynecological cancers, focusing on the potential of Jemperli-based combinations2.

Previous Success:
Jemperli has previously shown success in endometrial cancer, with a broad FDA label expansion allowing its use in first-line treatment regardless of biomarker status1.

Sources:

1. https://www.biospace.com/fda/gsk-wins-broad-label-expansion-for-jemperli-in-first-line-endometrial-cancer

2. https://www.clinicaltrialsarena.com/news/gsk-combo-primary-endpoint/

3. https://endpts.com/gsks-zejula-jemperli-combo-in-ovarian-cancer-hits-primary-endpoint-misses-on-overall-survival/

4. https://cafepharma.com/boards/threads/gsk-posts-mixed-survival-data-for-jemperli-zejula-combo-in-first-line-ovarian-cancer.705565/