FDA alerts on efficacy issues for some patients taking Keytruda and Tecentriq in urothelial cancer trials

The US Food and Drug Administration is alerting health care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of two important  immuno-oncology drugs.

The alert refers to Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) and Roche’s (ROG: SIX) Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

In two ongoing clinical trials (KEYNOTE-361 and IMVIGOR-130), the Data Monitoring Committees’ (DMC) early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy. There was no change in the adverse event profile of Keytruda or Tecentriq. Both Merck and Roche subsidiary Genentech have stopped enrolling patients whose tumors have PD-L1 low status to the Keytruda or Tecentriq monotherapy arms per the DMCs’ recommendations.