The Food and Drug Administration (FDA) has issued an alert regarding an efficacy issue identified in clinical trials where patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of programmed death ligand 1 (PD-L1) were treated with Keytruda (pembrolizumab; Merck) or Tecentriq (atezolizumab; Genentech) monotherapy.

Data Monitoring Committees (DMC) from two ongoing clinical trials (KEYNOTE-361 and IMVIGOR-130) found that in the monotherapy arms of these studies, patients with low PD-L1 status had decreased survival compared with those who received cisplatin- or carboplatin-based chemotherapy. The 2 trials are comparing platinum-based chemotherapy combined with Keytruda or Tecentriq to platinum-based chemotherapy alone. Additionally, both trials have a third arm of monotherapy with Keytruda or Tecentriq; this arm is being compared to platinum-based chemotherapy alone. The monotherapy arm has now stopped enrolling patients with low PD-L1 status as per the DMC recommendations. 

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Keytruda and Tecentriq are currently approved under accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma patients who are not eligible for cisplatin-containing chemotherapy. 

In a statement the FDA said that, “The populations enrolled in the ongoing clinical trials were eligible for platinum-containing chemotherapy, and therefore differ from those enrolled in the trials that led to the accelerated approvals of both Keytruda and Tecentriq in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.”

Those taking either treatment for other approved uses should continue to take the medication as directed by their healthcare professional. 

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