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FDA puts clinical hold on Merck’s three blood cancer trials

PBR Staff Writer Published 06 July 2017

The US Food and Drug Administration (FDA) has placed a clinical hold on three combination studies of Merck’s Keytruda (pembrolizumab) for the treatment of blood cancer.

The clinical hold has been placed on Keynote-183, Keynote-185 and Keynote-023 combination studies of the anti-PD-1 therapy, Keytruda, to treat blood cancer multiple myeloma.

FDA has decided to hold the trials following the assessment of data by the data monitoring committee in which more deaths have been observed in the Keytruda arms of Keynote-183 and Keynote-185 studies.

The regulator said the available data indicate that the risks of Keytruda plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma.

All patients recruited in Keynote-183 and Keynote-185, as well as in the Keytruda/ lenalidomide/dexamethasone cohort in Keynote-023 will discontinue investigational treatment with Keytruda.

Keynote-183 is a phase III study of pomalidomide and low-dose dexamethasone with or without pembrolizumab in refractory or relapsed and refractory multiple myeloma

Keynote-185 is a phase III study of lenalidomide and low-dose dexamethasone with or without pembrolizumab in newly diagnosed and treatment naïve multiple myeloma.

In addition, the partial clinical hold has been placed on Keynote-023, which is a phase I multi-cohort trial of pembrolizumab in combination with backbone treatments for subjects with multiple myeloma.

Keynote-023 trail’s cohort 1 assessed Keytruda in combination with lenalidomide and dexamethasone in patients who received prior anti-multiple myeloma treatment with an immunomodulatory (IMiD) treatment (lenalidomide, pomalidomide or thalidomide

Merck Research Laboratories president Dr Roger Perlmutter said: “Patient safety is Merck’s primary concern, and we are grateful to the study investigators and patients involved in these studies for their commitment to this important research.

“Merck’s development program for Keytruda, spanning more than 30 different tumor types, has one priority: helping patients suffering from cancer.”


Image: The FDA has placed a clinical hold on three combination studies of Merck’s Keytruda. Photo: courtesy of Merck Sharp & Dohme Corp.