FDA Places Holds on Imfinzi Trials Following Unexplained Deaths in Keytruda Trials

CheckMate-602 is an open-label, randomized phase III trial evaluating combinations of nivolumab, elotuzumab (Empliciti), pomalidomide, and dexamethasone for patients with relapsed/refractory multiple myeloma.

On Wednesday, the agency placed a partial clinical hold on three studies testing the med alongside Celgene's Revlimid (lenalidomide) or Pomalyst (pomalidomide)-the same meds used in the three affected Keytruda studies-for patients with relapsed or refractory forms of the disease, the New Jersey drug giant said.

Officials at the US Food & Drug Administration have put 12 clinical trials on hold, Reuters reports, after reviewing troubling data from a study on Keytruda, the immunotherapy drug manufactured by Merck that is now being tested as a treatment for multiple myeloma.

Now - just a month later - data from the trial on overall survival shows a clear benefit for the combination compared to Pfizer's targeted RCC therapy Sutent (sunitinib), although BMS isn't giving away the details just yet. The hazard ratio (HR) for overall survival (OS) for the Keytruda group compared with the control arm was 1.61, translating into a greater than 50 percent increase in the relative risk of death.

The Food and Drug Administration (FDA) recently released a statement providing data from the two phase 3 trials testing Keytruda (pembrolizumab) in patients with multiple myeloma. In response to this determination, the FDA began looking into other PD-1 inhibitors being explored as a combination therapy for multiple myeloma. Enrolled patients who are experiencing clinical benefit can continue treatment, but no new patients will be allowed to join the trials for the time being.

The hold does not affect ongoing nivolumab trials in other clinical areas, it added.

Merck's KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, which paired the company's blockbuster Keytruda with Celgene's Pomalyst or Revlimid to treat multiple myeloma, had been found to have a higher risk of death in the Keytruda arm than the placebo. "The true cause of the safety concerns", according to an FDA press release, has not yet been determined.

This prompted the agency to shut down one Keytruda trial and place several others on partial hold in July 2017. A full clinical hold was placed on MEDI4736-MM-002, which is examining durvalumab plus lenalidomide and dexamethasone in multiple myeloma patients.

CheckMate -214 study evaluating Opdivo in combination with Yervoy stopped early for demonstrating overall survival benefit in patients with previously untreated advanced or metastatic renal cell carcinoma. The decision was later extended to three Bristol-Meyers Squibb trials investigating Opdivo (nivolumab), which also targets the PD-1/PD-L1 pathway.

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