Where Does KEYNOTE-B96 Regimen Fit in Pretreated Ovarian Cancer?

The FDA approved pembrolizumab (Keytruda) and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with paclitaxel, with or without bevacizumab (Avastin), in adult patients with platinum-resistant ovarian cancers that express PD-L1 and have received 1 or 2 prior systemic treatments on February 10, 2026. Following that approval, CancerNetwork® spoke with Emese Zsiros, MD, PhD, FACOG, about the significance of the decision.

Zsiros, the Shashi Lele, MD, Endowed Chair in Gynecologic Oncology at Roswell Park Comprehensive Cancer Center, emphasized that guidelines currently outline a list of therapies for second-line platinum-resistant ovarian cancer. Among them, she highlighted mirvetuximab soravtansine-gynx (Elahere) and pegylated doxorubicin.

The newly approved pembrolizumab regimens were evaluated in the phase 3 KEYNOTE-B96 trial (NCT05116189), which achieved a median progression-free survival of 8.3 months (95% CI, 7.0-9.4) vs 7.2 months (95% CI, 6.2-8.1) with placebo (HR, 0.72; 95% CI, 0.58-0.89; P = .0014). Notably, the median overall survival was 18.2 months (95% CI, 15.3-21.0) vs 14.0 months (95% CI, 12.5-16.1), respectively (HR, 0.76; 95% CI, 0.61-0.94; P = .0053). The safety of pembrolizumab-based treatment in the KEYNOTE-B96 trial was similar with previous reports of the agent in other trials.

Transcript:

When we look at the NCCN guidelines, there's a whole list of second-line chemotherapies that are currently approved in platinum-resistant ovarian cancer. Some of them, such as mirvetuximab [soravtansine], are…tied to biomarker expression such as [folate receptor-alpha]. However, traditional second-line chemotherapies, such as doxorubicin or pegylated doxorubicin, gemcitabine, and topotecan are not tied to biomarker expression; those are still very much available as standard-of-care therapeutic options. Overall, the response rates for those second-line chemotherapies are much lower—in the 10% to 15% range—with a median progression-free survival between 2 and 4 months. Compared with a single-agent traditional second-line chemotherapy, the [KEYNOTE-B96 regimen] provides a much higher response rate and a meaningfully significant progression-free and overall survival benefit.

Reference

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. News release. FDA. February 10, 2026. Accessed February 16, 2026. https://tinyurl.com/ydzhnzha