Pembrolizumab Improves PFS in Recurrent Ovarian Cancer
The KEYNOTE-B96 study of pembrolizumab plus paclitaxel in recurrent platinum-resistant ovarian cancer has met its primary end point of progression-free survival.
Ovarian cancer: © Dr_Microbe - stock.adobe.com
Pembrolizumab (Keytruda) plus paclitaxel with or without bevacizumab (Avastin) led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with platinum-resistant recurrent ovarian cancer, meeting the primary end point of the phase 3 KEYNOTE-B96/ENGOT-ov65 study (NCT05116189).1
The benefit was seen in patients with tumors expressing PD-L1 and in all comers. The study also met a secondary end point of overall survival (OS), with a statistically significant improvement in patients with PD-L1-expressing tumors. The trial will continue to evaluate for OS, and analysis from the full study population will be completed in the future.
Findings will be presented at an upcoming medical meeting and shared with global regulatory authorities.
“This marks the first time a [pembrolizumab]-based regimen has shown the ability to help certain patients with platinum-resistant ovarian cancer live longer, and the first time an immune checkpoint inhibitor-based regimen has demonstrated an overall survival benefit in ovarian cancer,” said Gursel Aktan, MD, vice president, global clinical development, Merck Research Laboratories, in a press release. “The positive results from this trial add to the growing body of evidence supporting the potential benefit of [pembrolizumab] across gynecological cancers, including this difficult-to-treat form of ovarian cancer for which patients are in need of new options.”
Pembrolizumab is not currently FDA-approved to treat ovarian cancer. It is approved in combination with chemoradiotherapy to treatment patients with FIGO 2014 stage III to IVA cervical cancer; in combination with chemotherapy with or without bevacizumab in PD-L1-expressing persistent, recurrent, or metastatic cervical cancer; and as a single agent in recurrent or metastatic PD-L1-expressing cervical cancer with disease progression on or after chemotherapy. Additionally, pembrolizumab is approved in combination with carboplatin and paclitaxel followed by single-agent pembrolizumab for the treatment of primary advanced or recurrent endometrial carcinoma and as a single agent in microsatellite instability-high or mismatch repair-deficient endometrial carcinoma that is not eligible for curative surgery or radiation.
About KEYNOTE-B96/ENGOT-ov65
The phase 3 KEYNOTE-B96/ENGOT-ov65 trial enrolled an estimated 643 patients with platinum-resistant recurrent ovarian cancer across 187 global sites.2 Patients were randomized to receive pembrolizumab or placebo and paclitaxel with or without bevacizumab. Patients who experienced hypersensitivity to paclitaxel were able to receive docetaxel upon sponsor consultation.
Along with the primary end point of PFS and secondary end point of OS, additional secondary end points include incidence of adverse events (AEs), number of patients who discontinue treatment due to AEs, change from baseline in quality of life, and time to deterioration.
Patients were eligible for enrollment if they had received 1 or 2 prior lines of systemic therapy for ovarian cancer, including at least 1 prior platinum-based therapy. Patients were also required to have an ECOG performance status of 0 or 1 and adequate organ function. Those who experienced disease progression on weekly paclitaxel alone, received more than 2 prior lines of systemic therapy for ovarian cancer, received radiation within 2 weeks of study intervention, had an additional malignancy requiring active treatment within the past 3 years, or had active central nervous system metastases were not eligible for participation in the study.
