Pembrolizumab (PD-1) + weekly paclitaxel extends OS in platinum-resistant ovarian cancer (KEYNOTE-B96)

Pembrolizumab is an anti–PD-1 checkpoint inhibitor combined here with weekly paclitaxel (microtubule inhibitor), with optional bevacizumab (anti-VEGF) per investigator, in the randomized double-blind Phase 3 ENGOT-ov65/KEYNOTE-B96 trial (NCT05116189) in platinum-resistant recurrent epithelial ovarian/fallopian tube/primary peritoneal cancer after 1–2 prior systemic regimens (n=643). PFS improved at interim analysis in PD-L1 CPS≥1 (mPFS 8.3 vs 7.2 months; HR 0.72; p=0.0014) and in the overall population (8.3 vs 6.4 months; HR 0.70; p<0.0001); OS was improved in PD-L1 CPS≥1 at interim (mOS 18.2 vs 14.0 months; HR 0.76; p=0.0053) and in the overall population at final (17.7 vs 14.0 months; HR 0.82; p=0.011). Grade ≥3 treatment-related AEs were higher with pembrolizumab (68% vs 55%), with immune-toxicity deaths reported (eg, colitis, ILD); efficacy looks directionally above the historical weekly chemo ± bevacizumab benchmark from AURELIA (bev+chemo mPFS 6.7 months vs 3.4 months with chemo alone; ORR 30.9% vs 12.6%).