Merck, Eisai to discontinue late-stage study for skin cancer

Global pharmaceutical companies Merck & Co and Eisai said on Friday they were discontinuing a late-stage study of Keytruda and Lenvima for the treatment of adults with unresectable or metastatic melanoma, as the trial did not show improvement in overall survival.

The decision to discontinue the trial was based on the recommendation of an independent data monitoring committee after an interim analysis, the companies said. Improvement in overall survival was one of the study's dual main goals, according to Merck and Eisai.

An earlier interim analysis pertaining to the other main goal of progression-free survival had shown a statistically significant improvement in the Keytruda and Lenvima arm, compared with the Keytruda and placebo arm, the companies said.

They said another late-stage trial for Keytruda and Lenvima did not meet its main goal of overall survival for treating a type of colorectal or colon cancer.

Merck's blockbuster cancer drug Keytruda belongs to class of medicines called PD-1 inhibitors that work by increasing the ability of the body's immune system to help detect and fight tumour cells.

Eisai's Lenvima is a kinase inhibitor that blocks certain proteins from helping cancer cells grow and divide.

In September 2020, TimesLIVE reported that the approval of the drug in South Africa had been hailed as an “offer of renewed hope” for patients battling cancer. It was approved for the treatment of bladder cancer and first-line non-small cell lung carcinoma (NSCL) by the SA Health Products Regulatory Authority (Sahpra).

“The regulatory approval follows the review of studies and clinical trial data that showed the medicine was safe and effective against additional cancer types. This opens the door to many more cancer patients receiving effective treatment.

“The approved medicine is an immunotherapy treatment that enlists the body’s own immune system to fight cancer, and can reduce the need for major treatments such as chemotherapy,” Merck said at the time.

Keytruda was approved in 2017 to treat metastatic melanoma and advanced lung cancer.