Merck’s Keytruda Fails To Meet Endpoints In Bladder Cancer Trial


Merck (MRK) has announced disappointing results from its Phase 3 Keynote-361 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic bladder cancer.

The therapy did not meet its dual primary endpoints of overall survival (OS) or progression-free survival (PFS), compared with standard of care chemotherapy.

In the final analysis of the study, there was an improvement in OS and PFS for patients treated with Keytruda in combination with chemotherapy compared to chemotherapy alone; however, these results did not meet statistical significance.

Keytruda’s safety profile in the trial was consistent with previously reported studies, and no new safety signals were identified, Merck said. The study had enrolled 1,010 patients.

“While we are disappointed in these study results, Keytruda has been established as an important option in the treatment of metastatic bladder cancer, and we are committed to continuing our research to help more patients with this disease” commented Dr. Roy Baynes, CMO of Merck Research Laboratories.

Indeed, Keytruda already has three FDA-approved bladder cancer indications across multiple types and stages of bladder cancer. Plus Merck is still evaluating Keytruda as a monotherapy and in combination with other anti-cancer therapies across several disease settings (i.e., metastatic, muscle invasive bladder cancer, and non-muscle invasive bladder cancer).

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Shares in Merck are falling 10% on a year-to-date basis, but analysts have a bullish outlook on the stock with a Strong Buy consensus. This is made up of 9 recent buy ratings vs 2 hold ratings. The average analyst price target stands at $92 (12% upside potential). (See Merck stock analysis on TipRanks)

Following ASCO 2020, Mizuho Securities’ Mara Goldstein wrote “A key take-away for us on MRK is the likelihood of continued dominance for Keytruda and the opportunity of the company to add to its immuno-oncology arsenal.” She has a buy rating on the stock and $100 price target.

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