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Pembrolizumab plus chemotherapy with or without bevacizumab improved overall survival in platinum-resistant ovarian cancer.
Treatment with the pembrolizumab (Keytruda) in combination with chemotherapy with or without bevacizumab (Avastin) led to a statistically significant and clinically meaningful improvement in overall survival (OS) compared with placebo plus chemotherapy with or without bevacizumab in patients with platinum-resistant, recurrent ovarian cancer, meeting a secondary end point of the phase 3 KEYNOTE-B96/ENGOT-ov65 trial (NCT05116189).1
In an announcement from Merck, the company noted that in the trial’s final analysis, OS improvement was observed in the all-comer population, irrespective of PD-L1 expression. Data from this final analysis will be presented at an upcoming medical meeting.
Previously, Merck announced that KEYNOTE-B96 met its primary end point of progression-free survival (PFS) in the PD-L1–positive and all-comer populations, as well as the secondary end point of OS in the PD-L1–positive population.2 Data from these interim analyses will be presented on Saturday, October 18, during the first Presidential Symposium at the 2025 ESMO Congress.1
“The results from the KEYNOTE-B96 trial mark the first time ever that an immune checkpoint inhibitor–based regimen has demonstrated the potential to help all patients with platinum-resistant, recurrent ovarian cancer,” Gursel Aktan, MD, PhD, vice president of Global Clinical Development at Merck Research Laboratories, stated in a news release. “These women face a very poor prognosis with limited options for treatment, and this impactful news is a testament to our tireless commitment to exploring new options for patients with gynecologic cancers who face a critical unmet need.”
The randomized, double-blind study enrolled patients at least 18 years of age with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who received 1 to 2 prior lines of systemic therapy, including at least 1 prior platinum-based regimen.3 Prior treatment with a PARP inhibitor, PD-(L)1 inhibitor, bevacizumab, or hormonal therapy was permitted. Patients needed to have radiographic disease progression within 6 months after the final dose of platinum-based chemotherapy.
Other key inclusion criteria comprised radiographically evaluable disease that was measurable or non-measurable per RECIST 1.1 criteria; an ECOG performance status of 0 or 1; and adequate organ function.
Patients were excluded if they had nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, or undifferentiated carcinoma. Investigators also excluded patients with primary platinum-refractory disease, defined as radiographic progressive disease during or within 28 days of the last dose of first-line platinum-based therapy. Other exclusion criteria included prior disease progression on weekly paclitaxel alone; a diagnosis of immunodeficiency or ongoing chronic systemic steroid therapy; and known active central nervous system metastases and/or carcinomatous meningitis.
Patients were randomly assigned to receive pembrolizumab at 400 mg infusion for once every 6 weeks for 18 cycles plus paclitaxel at 80 mg/m2 on days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression, with or without bevacizumab at 10 mg/kg every 2 weeks until intolerance, disease progression, or investigator's discretion; or placebo plus the same paclitaxel regimen with or without the same bevacizumab regimen. Notably, in both arms, docetaxel at 75mg/m2 was allowed in place of paclitaxel for those who experienced a severe hypersensitivity reaction.
Along with the primary end point of investigator-assessed PFS and secondary end point of OS, other secondary end points comprised PFS per blinded independent central review, safety, and quality of life.
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