BMS hit by clinical trial hold from FDA

The FDA has placed a partial hold on clinical trials involving Bristol-Myers Squibb’s immunotherapy treatment, Opdivo, when used in combination with certain medicines in treating patients with multiple myeloma.

This news follows on from the FDA’s previous action against MSD’s Keytruda that was placed under a full hold after observers of trials noted a higher risk of death in the drug arms of the trial. Both Keytruda and Opdivo were being examined alongside pomalidomide or lenalidomide to determine whether they were able to boost the efficacy of the immunotherapies.

The FDA revealed that the decision was based on data from the KEYNOTE-183 and KEYNOTE-185 trial. In the same statement, it revealed that other PD-1/PD-L1 cancer drugs would also be undergoing clinical evaluation. This led to the cautious step to place a partial hold on trials in the same area for Opdivo, though there has been no release relating to an increase in risk of death during BMS’ trials.

Due to the partial hold, no new patients will be enrolled in the three trials currently running in the area – CheckMate-602, CheckMate-039 and CA204142 – but all patients who are seeing benefits with the combination treatment will continue to receive it.

The hold is another example of immunotherapy treatments hitting barriers in finding new methods of pushing the efficacy of the therapies. Both BMS and MSD are running trials numbering above a hundred each, meaning that such stumbling blocks are not entirely unexpected. However, it has been an unusual occurrence for both companies that have been highly successful, and lucrative, in providing a new form of treatment for a number of cancers.

A statement released by the company noted: “Bristol-Myers Squibb remains steadfast in our commitment to improve outcomes for patients with multiple myeloma, and will work closely with the FDA to address concerns.”

Ben Hargreaves