Merck & Co pauses two Ph III Keytruda studies after patient deaths

By Gareth Macdonald contact

- Last updated on GMT

iStock/Sashkinw
iStock/Sashkinw

Related tags: Cancer

Merck & Co has halted two Phase III studies examining its drug Keytruda (pembrolizumab) in combination with other therapies after reports of patient deaths.

Merck said it paused the trials – Keynote-183 and Keynote-185 - on the recommendation of a data monitoring committee, explaining the decision will “allow for additional information to be collected to better understand more reports of death in the Keytruda groups​.”

Keynote-183 is examining a regimen combining Keytruda, low-dose dexamethasone and Celgene’s Pomalyst (pomalidomide) in patients with relapsed or refractory multiple myeloma.

Keynote-185 is testing the Merck drug in combination with Celgene’s Revlimid (lenalidomide) in patients with treatment-naïve forms of the blood cancer.

A spokeswoman for the firm declined to comment when asked how many patients had died during the trials, telling us "we have no additional information to provide at this time. The analyses need to be conducted.​"

Background

Earlier this month the US Food and Drug Administration (FDA) approved Keytruda for adult and paediatric patients with unresectable or metastatic solid tumours with an identified microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) biomarker.

The approval decision was a first for the agency as Richard Pazdur, acting director of the FDA’s Office of Hematology and Oncology Products, explained.

“Until now, the FDA has approved cancer treatments based on where in the body the cancer started – for example, lung or breast cancers. We have now approved a drug based on a tumour’s biomarker without regard to the tumour’s original location.”​ 

Keytruda is also approved for the treatment of patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.

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