May 24, 2024

The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey

Merck’s patent on Keytruda is set to expire in 2028.
Image: Brendan McDermid (Reuters)

Merck announced Monday that it is pulling the plug on its phase 3 trial of an experimental combination treatment for skin cancer after side effects of the medication led patients to drop out of the study.

The study was testing whether a combination of the company’s flagship cancer drug Keytruda and its experimental antibody vibostolimab was more effective at treating resected high-risk melanoma compared to Keytruda alone.

A pre-planned analysis of the study found that a higher rate of discontinuations from patients taking the combined treatment — compared with those only taking Keytruda — made it “highly unlikely that the trial could achieve a statistically significant improvement” in its primary endpoint. The side effects were primarily related to “immune-mediated adverse experiences.”

An independent data monitoring committee recommended that patients taking the combined medication should be offered the option to be treated with just Keytruda.

“Through our clinical development program, we continue to ask the tough questions in an effort to fully explore the potential of novel coformulations and combinations that build on the foundation of Keytruda, with a goal to improve upon current standards of care and help even more patients with cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, in a press release.

Merck said it will share results of the trial with the scientific community and regulatory bodies.

The company will continue testing vibostolimab in combination with Keytruda for other types of cancers, even though the treatment has had other setbacks.

The Food and Drug Administration first approved Keytruda in 2014 to treat melanoma. Since then, it has received approval to treat several types of cancers, including lung cancer and carcinoma. The pharma company is now preparing for its patent on the drug to expire in 2028. One way drug companies deal with looming patent expirations is to combine drugs and then patent those new formulations.

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