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Merck Announces Phase 3 KEYNOTE-826 Trial Met Dual Primary Endpoints of OS and PFS

June 22, 2021: Merck known as MSD outside the United States and Canada announced that the pivotal Phase 3 KEYNOTE-826 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with or without bevacizumab, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with persistent, recurrent or metastatic cervical cancer.

Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA plus platinum-based chemotherapy with or without bevacizumab demonstrated statistically significant and clinically meaningful improvements in OS and PFS compared to the same platinum-based chemotherapy regimens with or without bevacizumab alone, regardless of PD-L1 status; KEYTRUDA is the first anti-PD-1/PD-L1 therapy to demonstrate this.

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The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.

“Despite progress with prevention and screening, cervical cancer continues to be a major health problem, often affecting younger and middle-aged women,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

“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.”

The Phase 3 KEYNOTE-826 trial is also the confirmatory trial for the current accelerated approval for KEYTRUDA 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 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test.

Merck is rapidly advancing a broad portfolio in women’s cancers with an extensive clinical development program for KEYTRUDA and several other investigational and approved medicines across multiple gynecologic and breast cancers.

About KEYNOTE-826

KEYNOTE-826 is a randomized, triple-blind, Phase 3 trial (ClinicalTrials.gov, NCT03635567) evaluating KEYTRUDA in combination with platinum-based chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with or without bevacizumab compared with placebo in combination with the same platinum-based chemotherapy regimens with or without bevacizumab for the first-line treatment of adult patients with persistent, recurrent or metastatic cervical cancer.

The trial enrolled adults with 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 curative treatment (such as surgery and/or radiation).

The primary endpoints are OS and PFS. The secondary endpoints include objective response rate, duration of response and safety. The study enrolled 617 patients who were randomized to receive:

  • KEYTRUDA (200 mg intravenously) plus investigator’s choice of the one of four platinum-based chemotherapy regimens: paclitaxel (175 mg/m2) plus cisplatin (50 mg/m2) with or without bevacizumab (15 mg/kg); or paclitaxel (175 mg/m2) plus carboplatin Area Under the Curve (AUC) 5 with or without bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately two years); or
  • Placebo plus investigator’s choice of the one of four platinum-based chemotherapy regimens: paclitaxel (175 mg/m2) plus cisplatin (50 mg/m2) with or without bevacizumab (15 mg/kg); or paclitaxel (175 mg/m2) plus carboplatin AUC 5 with or without bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately two years).”

    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/

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