Dr Zsiros on the Use of Pembrolizumab/Paclitaxel/Bevacizumab for Ovarian Cancer

“[Ovarian cancer] is no longer a homogeneous disease at the time of recurrence, and treatment selection is going to be more biomarker driven.”

Emese Zsiros, MD, PhD, FACOG, a professor of oncology, chair of the Department of Gynecologic Oncology, co-leader of the Tumor Immunology and Immunotherapy CCSG Program, and the Shahi Lele, MD, Endowed Chair in Gynecologic Oncology at the Roswell Park Comprehensive Cancer Center; as well as a clinical associate professor at the Jacobs School of Medicine and Biomedical Sciences at the State University of New York at Buffalo, discussed the significance of the FDA approval of pembrolizumab (Keytruda) plus paclitaxel with or without bevacizumab (Avastin) for the treatment of patients with PD-L1–positive platinum-resistant ovarian cancer.

On February 10, 2026, the FDA approved pembrolizumab, as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with a PD-L1 combined positive score (CPS) of at least 1, as determined by an FDA-authorized test, and previous treatment with 1 or 2 systemic therapy regimens. This regulatory decision was backed by data from the phase 3 KEYNOTE-B96 trial (NCT05116189), in which patients with PD-L1–positive disease with a CPS of at least 1 (n = 466) who received pembrolizumab plus paclitaxel with or without bevacizumab 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) for those treated with placebo plus paclitaxel with or without bevacizumab (HR, 0.72; 95% CI, 0.58-0.89; P = .0014).

Zsiros emphasized that this disease can no longer be characterized as a homogeneous entity at the clinical point of recurrence. Instead, she noted that the selection of subsequent treatment lines is increasingly dictated by specific biomarker-driven insights. Currently, folate receptor expression and HER2 expression represent 2 of the most clinically relevant biomarkers used to guide therapeutic sequencing in the recurrent setting, Zsiros explained. She pointed out that although BRCA mutational status and homologous recombination deficiency signatures remain foundational in frontline maintenance therapy, their clinical relevance tends to decrease as disease progresses into the recurrent setting. Additionally, she reported that oncologists evaluate for mismatch repair deficiency and high tumor mutational burden to determine eligibility for single-agent immune checkpoint blockade. However, she added that this patient population remains small, encompassing only approximately 1% to 3% of the total ovarian cancer patient population.