September 25, 2017

FDA Adds Two Roche Multiple Myeloma Studies Evaluating Checkpoint Inhibitors to List of Partial Clinical Holds Over Safety Concerns


Alarmed that an imbalance in deaths among patients taking a combination of Keytruda (pembrolizumab) with Celgene’s Pomalyst and Revlimid could represent a threat in that whole class of checkpoint comboinations, the FDA has added two Tecentriq (atezolizumab) clinical studies to its growing list of clinical trials placed on partial hold over safety concerns while further evaluation takes place.

Now Roche’s Phase Ib and a Phase Ib/II in relapsed/refractory multiple myeloma and relapsed/refractory follicular lymphoma will temporarily stop enrolling new patients though the volunteers who have already signed up can continue.

A few few days ago regulators also placed a hold on in Bristol-Myers Squibb’s three rival studies concentrating on multiple myeloma and immunotherapy with checkpoint inhibitors. A trial evaluating Imfinzi (durvalumab) was also placed on hold shortly thereafter.

Checkpoint inhibitors are a novel precision cancer immunotherapy that helps to restore the body’s immune system in fighting cancer. They create their anti-cancer effects by blocking a specific protein used by cancer cells called PD-1 and PD-L1, to escape an attack by the immune system. Once PD-L1 is blocked, cells of the immune system are able to identify cancer cells as a threat, and initiate an attack to destroy the cancer.  There are several PD-1 and PD-L1 inhibitors already approved for use to treat multiple cancer types.

The FDA has gone to some pains to outline its safety worries and provide a careful assessment of what’s been happening.


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Tags: checkpoint inhibitors, immunotherapy, Multiple Myeloma, News, PD-1, PD-L1, Uncategorized