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Ref Type
PMID
Authors N. Colombo, E. Zsiros, A. Sebastianelli, M. Bidzinski, C.E. Gallardo Araneda, E. Matanes, K. Hasegawa, F. Kose, M.E. Magallanes Maciel, R.A. Herbertson, S. Ananda, J.R. Kroep, A.C. de Melo, P.R. Debruyne, J-W. Kim, X. Peng, K.U. Yamada, A.M. Bogusz, T. De La Motte Rouge, X. Wu
Title LBA3 Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase III ENGOT-ov65/KEYNOTE-B96 study
Journal Vol Issue Date Pages Journal Short Title
Annals of Oncology 36 Supplement 2 S1582 Ann Oncol
URL https://www.annalsofoncology.org/article/S0923-7534(25)04819-7/fulltext
Abstract Text Background Pembrolizumab combined with weekly paclitaxel demonstrated antitumor activity and manageable safety in a previous phase 2 study of platinum-resistant recurrent ovarian cancer (PRROC). The phase 3 ENGOT-ov65/KEYNOTE-B96 trial (NCT05116189) evaluated pembrolizumab plus weekly paclitaxel, with or without bevacizumab, in this setting. Methods Eligible participants had histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; 1–2 prior systemic regimens (≥1 platinum-based, ≥4 cycles in first line); and platinum-resistant disease (progression ≤6 months after last platinum dose). Participants were randomized 1:1 to pembrolizumab 400 mg IV every 6 weeks or placebo, each combined with weekly paclitaxel (80 mg/m2 on days 1, 8, and 15 of each 3-week cycle) ± bevacizumab (10 mg/kg every 2 weeks) until progression or unacceptable toxicity. The primary endpoint was investigator-assessed progression-free survival (PFS); overall survival (OS) was the key secondary endpoint. Results A total of 643 participants were randomized (322 pembrolizumab, 321 placebo). At interim analysis 1 (median follow-up, 15.6 mo), pembrolizumab significantly improved PFS in the PD-L1 CPS ≥1 (8.3 vs 7.2 months; HR 0.72 [95% CI, 0.58–0.89]; P=0.0014) and the overall (8.3 vs 6.4 months; HR 0.70 [0.58–0.84]; P<0.0001) populations. At interim analysis 2 (median follow-up, 26.6 mo), OS was significantly improved in the PD-L1 CPS ≥1 population (18.2 vs 14.0 months; HR 0.76 [0.61–0.94]; P=0.0053), with a favorable trend in the overall population (17.7 vs 14.0 months; HR 0.81 [0.68–0.97]; P=0.0114). Grade ≥3 treatment-related adverse events occurred in 67.5% versus 55.3% of participants, respectively. Conclusions Pembrolizumab plus weekly paclitaxel ± bevacizumab showed statistically significant and clinically meaningful improvements in PFS regardless of PD-L1 status and in OS in PD-L1 CPS ≥1 PRROC, with a manageable safety profile.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CD274 positive ovary epithelial cancer sensitive Bevacizumab + Paclitaxel + Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ENGOT-ov65/KEYNOTE-B96) that supported FDA approval, Keytruda (pembrolizumab) plus Taxol (paclitaxel), with or without Avastin (bevacizumab), significantly improved progression-free survival (8.3 vs 7.2 mo, HR 0.72, p=0.0014) and overall survival (18.2 vs 14.0 mo, HR 0.76, p=0.0053) in patients with CD274 (PD-L1)-positive (CPS>/=1) platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Annals of Oncology, Volume 36, S1582; NCT05116189). detail... detail...
CD274 positive ovary epithelial cancer sensitive Paclitaxel + Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ENGOT-ov65/KEYNOTE-B96) that supported FDA approval, Keytruda (pembrolizumab) plus Taxol (paclitaxel), with or without Avastin (bevacizumab), significantly improved progression-free survival (8.3 vs 7.2 mo, HR 0.72, p=0.0014) and overall survival (18.2 vs 14.0 mo, HR 0.76, p=0.0053) in patients with CD274 (PD-L1)-positive (CPS>/=1) platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Annals of Oncology, Volume 36, S1582; NCT05116189). detail... detail...