Immuno-Oncology Resource Center
Immuno-Oncology Resource Center
May 21, 2018
1 min read
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FDA issues alert on decreased survival with pembrolizumab or atezolizumab for urothelial cancer

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The FDA alerted health care professionals and clinical investigators to decreased survival associated with pembrolizumab or atezolizumab monotherapy for the treatment of patients with metastatic urothelial cancer who have not received prior therapy and have low PD-L1 expression, according to a review of two trials.

Interim results from two trials — KEYNOTE-361 for pembrolizumab (Keytruda, Merck) and IMVIGOR-130 for atezolizumab (Tecentriq, Genentech) — showed patients in the monotherapy arms with low PD-L1 had decreased survival compared with patients who received cisplatin- or carboplatin-based chemotherapy.

The FDA approved both pembrolizumab and atezolizumab under accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma patients who are not eligible for cisplatin-containing chemotherapy, irrespective of PD-L1 status. Patients enrolled in the monotherapy arms of KEYNOTE-361 and IMVIGOR-130 were eligible for platinum-containing chemotherapy.

Researchers did not observe a change in the adverse event profile of either drug.

Both manufacturers have stopped enrolling patients with low PD-L1 status to the monotherapy arms of the KEYNOTE-361 and IMVIGOR-130 trials. The trials also included a combination arm consisting of pembrolizumab or atezolizumab plus platinum-based chemotherapy compared with chemotherapy alone. Those arms remain open for enrollment.

The FDA’s warning does not apply to other approved indications for pembrolizumab or atezolizumab.