Merck Announces KEYTRUDA (pembrolizumab) Significantly Improved Progression-Free Survival as First-Line Treatment for Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Defic
APRIL 02, 2020
First Positive Head-to-Head Phase 3 Trial Comparing a Single-Agent Cancer Medicine to Standard of Care Chemotherapy as First-line Treatment for MSI-H or dMMR Colorectal Cancer
Merck to Share Data from KEYNOTE-177 with Global Regulatory Authorities and at an Upcoming Medical Congress
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-177 trial evaluating first-line treatment of KEYTRUDA, Merck?s anti-PD-1 therapy, in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer met one of its dual primary endpoints of progression-free survival (PFS). Based on an interim analysis conducted by an independent Data Monitoring Committee (DMC), KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy (investigator?s choice of mFOLFOX6 or FOLFIRI, with or without bevacizumab or cetuximab). Based on the recommendation of the DMC, the study will continue without changes to evaluate overall survival (OS), the other dual primary endpoint. The safety profile of KEYTRUDA in this trial was consistent with previously reported studies, and no new safety signals were identified. ?These head-to-head data with KEYTRUDA are the first time a single-agent, anti-cancer therapy, and particularly an anti-PD-1 monotherapy, achieved a statistically significant improvement in progression-free survival over chemotherapy, including the current standard of care regimen of mFOLFOX6 plus bevacizumab, in patients with MSI-H colorectal cancer,? said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. ?These data in the first-line treatment setting provide further evidence of the benefits of KEYTRUDA monotherapy in patients whose tumors are MSI-H or dMMR. We look forward to sharing these data as quickly as possible with the medical community and regulatory authorities.? In May 2017, KEYTRUDA became the first cancer therapy approved by the U.S. Food & Drug Administration for use based on a biomarker, regardless of tumor type, in previously treated patients with MSI-H or dMMR solid tumors. Microsatellite instability (or MSI) is defined by the National Cancer Institute as a change that occurs in the DNA of certain cells (such as tumor cells) in which the number of repeats of microsatellites (short, repeated sequences of DNA) is different from the number of repeats that was in the DNA when it was inherited. The cause of microsatellite instability may be a defect in the ability to repair mistakes made when DNA is copied in the cell. This defect is also referred to as mismatch repair deficient (dMMR). It is estimated that approximately 10-15% of colorectal cancer patients have tumors that score as either MSI-H or dMMR when testing is performed. About KEYNOTE-177 KEYNOTE-177 (ClinicalTrials.gov,?NCT02563002) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA monotherapy versus standard of care chemotherapy for the first-line treatment of patients with MSI-H or dMMR advanced colorectal cancer. The dual primary endpoints are PFS and OS, and the secondary endpoint is ORR. The study enrolled 308 patients who were randomized to receive either:- KEYTRUDA (200 mg fixed dose every three weeks for up to 35 cycles of treatment [up to approximately two years]); or
- Investigator?s choice of one of the following chemotherapy-based regimens: mFOLFOX6; mFOLFOX6 plus bevacizumab (5 mg/kg IV on Day 1 of each two-week cycle); mFOLFOX6 plus cetuximab (400 mg/m2?IV, then 250 mg/m2?weekly in each two-week cycle); FOLFIRI; FOLFIRI plus bevacizumab (5 mg/kg IV on Day 1 of each two-week cycle); or FOLFIRI plus cetuximab (400 mg/m2?IV, then 250 mg/m2?weekly in each two-week cycle).
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
Share this article on WhatsApp, LinkedIn and Twitter
X
Incisive News in 3 Shots.
Contact Us
- First Floor, B-66, Sector 63 Noida, Uttar Pradesh, INDIA - 201301
- +91-120 428 0707
- connect@pharmashots.com
- Newsletter
Our Information
Copyright © 2024 PharmaShots - All Rights Reserved.
Modal title
Modal body text goes here.