Merck's Experimental Favezelimab/Keytruda Combo Fails In Late-Stage Colorectal Cancer Study

On Wednesday, Merck & Co Inc MRK released topline data from the KEYFORM-007 Phase 3 study of the fixed-dose combination of favezelimab and pembrolizumab versus the standard of care for pretreated patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC).

The US drug giant said the study did not meet its primary endpoint of overall survival.

Also Read: Merck’s Keytruda Secures First FDA-Approval For Rare Form Aggressive Cancer.

At the final pre-specified analysis, the favezelimab and pembrolizumab fixed-dose combination did not demonstrate an improvement in OS compared to standard of care (regorafenib or TAS-102 [trifluridine and tipiracil hydrochloride]).

The safety profile of the fixed-dose combination was consistent with that observed for favezelimab and pembrolizumab in previously reported studies, with no new safety signals observed.

A full data evaluation is ongoing.

In the U.S., Keytruda is approved for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

Keytruda has not been approved for the treatment of MSS mCRC.

Last month, Merck stopped two Keytruda Phase 3 trials, KEYNOTE-867 and KEYNOTE-630, after underwhelming data.

Concurrently, on Wednesday, Japan’s drug regulator approved new indications for Keytruda (pembrolizumab), in certain lung and urothelial cancers.

Merck Stock Prediction For 2024

Equity research can be a valuable source of information for learning about a company's fundamentals. Analysts create financial models based on the fundamentals and expected future earnings of a company to arrive at a price target and recommendation for the stock.

Shares of Merck & Co have an average 1-year price target of $142.57, representing an expected upside of 24.02%.

Because of differences in assumptions, analysts can arrive at very different price targets and recommendations. No analysts have bearish recommendations on Merck & Co, while 5 analysts have bullish ratings. The street high price target from Cantor Fitzgerald is $155.0, while the street low from Wells Fargo is $125.0.

Price Action: MRK stock is down 0.10% at $114.85 during the premarket session at last check on Wednesday.

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Photo Courtesy of Merck