FDA Approves Merck’s KEYTRUDA Combination For PD-L1+ Platinum-Resistant Ovarian Cancer

Merck announced that the U.S. FDA has approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), in combination with paclitaxel, with or without bevacizumab, for adults with PD-L1–positive (CPS ≥1) platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have received one or two prior systemic regimens. The approval is based on results from the Phase 3 KEYNOTE-B96 (ENGOT-ov65) trial.

“For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback, it’s when options can become limited, and the reality patients face can change very quickly,” said Dr. Bradley Monk, gynecologic oncologist and medical director of the Late-Stage Clinical Research Program at Florida Cancer Specialists and Research Institute. “For patients who have been previously treated with standard platinum-based therapies, the FDA approvals of these pembrolizumab-based regimens offer the possibility of more time.”

In the PD-L1–positive population, KEYTRUDA plus chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) compared with placebo plus chemotherapy. The regimen reduced the risk of disease progression or death by 28% and reduced the risk of death by 24%. Median PFS was 8.3 months with the KEYTRUDA regimen versus 7.2 months with placebo, while median OS was 18.2 months versus 14.0 months, respectively. The trial enrolled 643 patients, including 72% with PD-L1–positive tumors.

“Historically, the prognosis has been poor for patients living with platinum-resistant recurrent ovarian cancer who have limited treatment options that may reduce the risk of disease progression or death. These approvals mark an important moment for the ovarian cancer community, reflecting years of focused investment in KEYTRUDA,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “Introducing the first PD-1 inhibitors for platinum-resistant ovarian cancer means we’re expanding what’s possible for patients facing this disease. It also reinforces our commitment to advancing innovative therapies and improved outcomes across women’s cancers, where the need is greatest.”

The safety profile was consistent with previous experience of KEYTRUDA in combination regimens. Serious adverse events occurred in 54% of patients receiving the KEYTRUDA combination, and fatal adverse events occurred in 3.9%. Common side effects included diarrhea, fatigue, nausea, alopecia, peripheral neuropathy, and urinary tract infections. KEYTRUDA QLEX’s approval is supported by pharmacokinetic and safety data demonstrating comparability to intravenous KEYTRUDA. The subcutaneous formulation is contraindicated in patients with hypersensitivity to its hyaluronidase component.