July 10, 2017

After patient deaths, FDA halts three clinical trials for new cancer drug

Daily Briefing

    Merck on Wednesday announced that FDA has placed a hold on three clinical trials that were testing the company's drug Keytruda as a treatment for blood cancer.

    Merck said FDA suspended the trials in response to data that showed trial participants who had received Keytruda were more likely to die than those who had received other treatments.

    Details of the clinical trial

    Merck is evaluating new uses of Keytruda, which is designed to strengthen the immune system to help fight tumors. According to the Wall Street Journal, Merck currently is evaluating Keytruda in more than 400 clinical trials.

    Merck in three of the clinical trials was testing the use of Keytruda in combination with standard multiple myeloma therapies—including dexamethasone and Celgene's Revlimid or Pomalyst—to treat blood cancer. Merck last month stopped enrolling new participants in two of the trials after an independent data monitoring committee observed more deaths occurred among participants who received Keytruda in combination with another treatment than among participants in the studies' control groups.

    FDA puts trials on hold

    Merck said FDA placed a full clinical hold on the two blood cancer trials in which the company had stopped enrolling new participants and a partial hold on the third trial. According to Merck, FDA had "determined that the data available at the present time indicate[d] that the risks of Keytruda plus [Pomalyst] or [Revlimid] outweigh any potential benefit for patients with multiple myeloma."

    As a result of the holds, patients taking Keytruda in combination with Pomalyst, Revlimid, or dexamethasone will discontinue use of Keytruda. According to the Journal, Merck said a portion of participants in the third trial also will stop receiving Keytruda.

    Merck said the clinical hold does not apply to the other studies testing Keytruda for additional uses.

    Comments

    A Merck spokesperson said the company did not have further details on the deaths of those who had participated in the studies.

    An FDA spokesperson could not immediately be reached for comment, the Journal reports (Loftus, Wall Street Journal, 7/5; Berkrot, Reuters, 7/5; Bean, Becker's Hospital Review, 7/6; Merck release, 7/5).

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