MSD’s Keytruda hits Phase 3 main goal in first-line colorectal cancer sub-population

pharmafile | April 3, 2020 | News story | Medical Communications, Research and Development MSD, colorectal cancer, keytruda, pharma 

MSD has lifted the veil on new Phase 3 for its blockbuster immunotherapy Keytruda, showing that the anti-PD-1 therapy met one of its main goals in the first-line treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer.

Data gathered during an interim analysis conducted by an independent Data Monitoring Committee (DMC) showed that the drug generated a “statistically significant and clinically meaningful improvement” in progression-free survival compared to an investigator’s choice of chemotherapy, meeting one of the study’s co-primary endpoints.

The second primary endpoint of overall survival has not yet been met, but based on this analysis the DMC has recommended that the trial continued unchanged in order to gather sufficient data to evaluate this second goal.

The immunotherapy’s safety profile was also found to be in line with previous data.

“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,” remarked Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at MSD.

He continued: “These data in the first-line treatment setting provide further evidence of the benefits of Keytruda monotherapy in patients whose tumours are MSI-H or dMMR. We look forward to sharing these data as quickly as possible with the medical community and regulatory authorities.”

Matt Fellows

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