How Tolerable is Pembrolizumab/Paclitaxel/Bevacizumab in PROC?

On February 10, 2026, 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.¹

Following this approval, CancerNetwork® spoke with Emese Zsiros, MD, PhD, FACOG, about the significance of adding this new regimen to the armamentarium of second-line platinum-resistant ovarian cancer treatments.

Zsiros, the Shashi Lele, MD, Endowed Chair in Gynecologic Oncology at Roswell Park Comprehensive Cancer Center, stated that she had 2 patients who took part in the phase 3 KEYNOTE-B96 trial (NCT05116189), from which supporting data for the FDA’s decision came.

Both patients reportedly did “remarkably well” with the newly approved regimen after having progressed within 3 months after their last platinum exposure; after 3 to 4 months of treatment, they showed no evidence of disease, and the paclitaxel was stopped due to toxicity. As of the interview, both patients still have no evidence of disease at 18 months after the clinical trial.

Transcript:

I actually have 2 patients—and I just saw both of them last week—who were a part of this clinical trial. Both had a remarkable response. They both were [patients with] platinum-resistant ovarian cancer, with a very short platinum-free interval, meaning that they progressed within 3 months after the last platinum exposure. They came on this clinical trial, and both did remarkably well. Both essentially [had] no evidence of disease after 3 to 4 months of weekly paclitaxel with the combination. They ultimately ended up stopping the weekly paclitaxel because of [adverse] effects but continued for an additional several months of maintenance with pembrolizumab or placebo plus bevacizumab. As we were blinded, we were not sure what the patients were receiving.

Then, we ultimately discontinued that as well because the patients were doing well and had multiple repeated negative CT scans. Both patients still [have] no evidence of disease 18 months after coming off the KEYNOTE-B96 clinical trial. [They] returned to normal life without any additional [adverse] effects. To me, that's a testament that in select groups of patients, this regimen can work extremely well. Although it initially appears to be a bit intense and toxic with the weekly [paclitaxel], it is an excellent chemotherapy to prime the immune system. When it's layered over additional potential maintenance with the checkpoint blockade—pembrolizumab plus or minus bevacizumab—we were able to achieve durable disease control.

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