Merck & Co Inc (MRK) experienced a setback in its quest to develop a new treatment option for patients with metastatic colorectal cancer (mCRC). The pharmaceutical giant announced that the KEYFORM-007 Phase 3 study of the fixed-dose combination of favezelimab and pembrolizumab did not meet its primary endpoint of overall survival in patients with pretreated microsatellite-stable (MSS) mCRC. This means the combination therapy, when compared to the standard of care (regorafenib or TAS-102), did not demonstrate a significant improvement in extending patients’ lives.
Despite this disappointing outcome, the safety profile of the fixed-dose combination was found to be consistent with the safety profiles of favezelimab and pembrolizumab observed in previous studies. No new safety signals were observed in the KEYFORM-007 trial. A full data evaluation is currently underway.
It’s important to note that Keytruda, Merck’s blockbuster immunotherapy drug, remains approved for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. However, it has not yet been approved for the treatment of MSS mCRC. This setback comes on the heels of Merck halting two other Keytruda Phase 3 trials, KEYNOTE-867 and KEYNOTE-630, earlier this year after disappointing data.
On a more positive note, Japan’s drug regulator recently approved new indications for Keytruda (pembrolizumab) in certain lung and urothelial cancers. This demonstrates the continued potential of Keytruda in other cancer types.
Despite the recent setbacks, analysts remain optimistic about Merck’s overall prospects. Shares of Merck & Co have an average 1-year price target of $142.57, representing an expected upside of 24.02%. No analysts have bearish recommendations on Merck & Co, while 5 analysts have bullish ratings.
While this news may be disappointing for those hoping for new treatment options for MSS mCRC, it’s important to remember that the research and development process is complex and often involves setbacks. Merck continues to invest heavily in cancer research and development, and this news is unlikely to deter their efforts in this area.
