Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study - PubMed
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- #Clinical Trial
- #Immunotherapy
- #Ovarian Cancer
- Pembrolizumab plus weekly paclitaxel significantly improved progression-free survival (PFS) in platinum-resistant recurrent ovarian cancer patients, with median PFS of 8.3 months vs 7.2 months in PD-L1 CPS ≥1 population and 8.3 months vs 6.4 months overall, compared to placebo plus paclitaxel.
- Overall survival (OS) was significantly improved with pembrolizumab plus paclitaxel, with median OS of 18.2 months vs 14.0 months in PD-L1 CPS ≥1 population and 17.7 months vs 14.0 months overall, compared to placebo plus paclitaxel.
- Grade 3 or worse treatment-related adverse events occurred more frequently in the pembrolizumab group (68% vs 55%), with common adverse events including anemia, peripheral neuropathy, alopecia, fatigue, and nausea; treatment-related deaths were reported in both groups.
- The study supports pembrolizumab plus weekly paclitaxel (with or without bevacizumab) as a new treatment option for platinum-resistant recurrent ovarian cancer patients who have received one to two prior systemic therapies.
- This was a phase 3, randomized, double-blind trial (ENGOT-ov65/KEYNOTE-B96) involving 643 participants across 25 countries, with primary endpoint of investigator-assessed PFS and key secondary endpoint of OS.