A phase 3 study found that pembrolizumab (Keytruda; Merck) in combination with platinum-based chemotherapy with or without bevacizumab (Avastin; Genentech) significantly improved overall survival (OS) and progression-free survival (PFS) in patients with persistent, recurrent or metastatic cervical cancer compared to platinum-based chemotherapy with or without bevacizumab. According to the authors of the KEYNOTE-826 trial (NCT03635567) results, this is the first anti-programmed death receptor-1 (PD-1)/PD-L1 therapy to demonstrate improvements in OS and PFS that were clinically meaningful and statistically significant regardless of PD-L1 status.
“Despite progress with prevention and screening, cervical cancer continues to be a major health problem, often affecting younger and middle-aged women,” said Roy Baynes, MD, PhD, senior vice president and head of global clinical development at Merck Research Laboratories, in a press release. “Women diagnosed with metastatic cervical cancer have a particularly poor prognosis, and there is an urgent need for new treatment options. KEYNOTE-826 is the first study to show positive results for immunotherapy in first-line persistent, recurrent or metastatic cervical cancer, and we look forward to sharing these findings at an upcoming congress and discussing them with regulatory authorities. We thank the patients, their caregivers and investigators for their participation in this important study.”
KEYNOTE-826, a randomized, triple-blind, phase 3 trial, enrolled 617 adult patients with persistent, recurrent, or metastatic persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix who had not been treated with systemic chemotherapy and who were no longer amenable to surgery, radiation, or other curative treatments. Patients were randomized into treatment arms and received either 200mg of pembrolizumab or placebo in combination with the investigator’s choice of 1 of 4 platinum-based chemotherapy regimens. According to the investigators, the safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies.
Additionally, the KEYNOTE-826 trial was also the confirmatory trial for the current accelerated approval for pembrolizumab in cervical cancer for the second-line treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA-approved test. Full results of the study will be presented at an upcoming medical meeting.
Merck Announces Phase 3 KEYNOTE-826 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Patients With Persistent, Recurrent or Metastatic Cervical Cancer [news release]. Merck; June 22, 2021. Accessed June 22, 2021. https://www.merck.com/news/merck-announces-phase-3-keynote-826-trial-met-dual-primary-endpoints-of-overall-survival-os-and-progression-free-survival-pfs-in-patients-with-persistent-recurrent-or-metastatic-cervical-cancer/