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ENGOT-ov65/KEYNOTE-B96

Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study

Phase 3N = 643NCT05116189

Population
Platinum-resistant recurrent epithelial ovarian, fallopian-tube or primary peritoneal carcinoma, one to two previous systemic regimens, progression within 6 months of the last platinum
Design
Randomised, double-blind phase 3 study at 187 centres in 25 countries. Participants with epithelial ovarian, fallopian-tube or primary peritoneal carcinoma, one to two previous systemic therapies including a platinum regimen, who progressed within 6 months of the last platinum were randomised 1:1 to pembrolizumab 400 mg every 6 weeks (up to 18 cycles) or placebo, each with open-label weekly paclitaxel 80 mg/m2 on days 1, 8 and 15 of a 21-day cycle; bevacizumab 10 mg/kg every 2 weeks was permitted at the investigator's discretion. Stratified by planned bevacizumab use, region and PD-L1 combined positive score (CPS). Primary end point investigator-assessed PFS; key secondary end point OS.
Primary endpoint
PFS
Arms
  • Pembrolizumab plus paclitaxel (experimental, n = 322): Pembrolizumab 400 mg every 6 weeks (up to 18 cycles) plus weekly paclitaxel 80 mg/m2, with or without bevacizumab
  • Placebo plus paclitaxel (control, n = 321): Placebo every 6 weeks (up to 18 cycles) plus weekly paclitaxel 80 mg/m2, with or without bevacizumab
People
Colombo N
PFSHR 0.72 (95% CI 0.58–0.89)Δ median PFS+1.1 monthsPFSHR 0.70 (95% CI 0.58–0.84)Δ median PFS+1.9 monthsOSHR 0.76 (95% CI 0.61–0.94)Δ median OS+4.2 months
Show the numbers
Results reported for ENGOT-ov65/KEYNOTE-B96
EndpointAnalysisPembrolizumab plus paclitaxelPlacebo plus paclitaxelEffect
PFSPD-L1 CPS 1 or higher (first interim analysis)interimColombo 2026median 8.3 monthsmedian 7.2 monthsHR 0.72 (95% CI 0.58–0.89)P=0.0014Investigator-assessed per RECIST 1.1; first interim analysis, which met the prespecified criteria for confirmatory efficacy.
PFSOverall population (N=643)interimColombo 2026median 8.3 monthsmedian 6.4 monthsHR 0.70 (95% CI 0.58–0.84)P<0.0001Investigator-assessed; first interim analysis.
OSPD-L1 CPS 1 or higher (second interim analysis)interimColombo 2026median 18.2 monthsmedian 14 monthsHR 0.76 (95% CI 0.61–0.94)P=0.0053Second interim analysis; key secondary end point.
OSOverall population (N=643)finalColombo 2026median 17.7 monthsmedian 14 monthsHR 0.82 (95% CI 0.69–0.97)P=0.011Final analysis, overall population.
Results reported for ENGOT-ov65/KEYNOTE-B96
EndpointAnalysisPembrolizumab plus paclitaxelPlacebo plus paclitaxelEffect
PFSPD-L1 CPS 1 or higher (first interim analysis)interimColombo 2026median 8.3 monthsmedian 7.2 monthsHR 0.72 (95% CI 0.58–0.89)P=0.0014Investigator-assessed per RECIST 1.1; first interim analysis, which met the prespecified criteria for confirmatory efficacy.
PFSOverall population (N=643)interimColombo 2026median 8.3 monthsmedian 6.4 monthsHR 0.70 (95% CI 0.58–0.84)P<0.0001Investigator-assessed; first interim analysis.
OSPD-L1 CPS 1 or higher (second interim analysis)interimColombo 2026median 18.2 monthsmedian 14 monthsHR 0.76 (95% CI 0.61–0.94)P=0.0053Second interim analysis; key secondary end point.
OSOverall population (N=643)finalColombo 2026median 17.7 monthsmedian 14 monthsHR 0.82 (95% CI 0.69–0.97)P=0.011Final analysis, overall population.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFSOSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.720.58–0.89
PFS0.70.58–0.84
OS0.760.61–0.94
OS0.820.69–0.97
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%05101520Months (modelled)
  • Pembrolizumab plus paclitaxel (experimental)
  • Placebo plus paclitaxel (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPembrolizumab plus paclitaxelPlacebo plus paclitaxel
0100.0%100.0%
565.9%61.8%
1043.4%38.2%
1626.3%21.4%
2117.3%13.2%
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%05101520Months (modelled)
  • Pembrolizumab plus paclitaxel (experimental)
  • Placebo plus paclitaxel (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPembrolizumab plus paclitaxelPlacebo plus paclitaxel
0100.0%100.0%
565.9%58.2%
1043.4%33.9%
1626.3%17.7%
2117.3%10.3%
Primary publication: Colombo N, Zsiros E, Parma G, Rulli E, Sebastianelli A, Bidzinski M, et al. Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2026;407(10538):1525-1537. PubMedDOI

Appears in

Sources

  1. Colombo N, Zsiros E, Parma G, Rulli E, Sebastianelli A, Bidzinski M, et al. Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2026;407(10538):1525-1537.

    PubMedDOI