FDA Accepts 2 sBLAs for Pembrolizumab for Bladder Cancer

The U.S. Food and Drug Administration (FDA) has granted priority review to 2 supplemental Biologics License Applications (sBLAs) for pembrolizumab (Keytruda) for locally advanced or metastatic urothelial carcinoma.¹

One application is for the first-line use of pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. The second is for the second-line use of the PD-1 inhibitor among patients with locally advanced or metastatic urothelial carcinoma who had disease progression on or after platinum-containing chemotherapy. The FDA is expected to take action on both sBLAs by June 14, 2017.

The first sBLA is based on data from the open-label, phase 2 KEYNOTE-052 trial (ClinicalTrials.gov Identifier: NCT02335424), which were presented at the European Society for Medical Oncology (ESMO) 2016 Congress.

The study showed that 24% of the 100 treatment-naïve patients with advanced urothelial cancer achieved an objective response, including 11 patients with a PD-L1 expression of 10% or greater.

The second application is based on findings from the phase 3 KEYNOTE-045 study (ClinicalTrials.gov Identifier: NCT02256436), which were presented at the European Cancer Congress (ECCO) 2017.

Treatment with pembrolizumab reduced the risk of death by nearly 28% compared with investigator’s choice of chemotherapy (hazard ratio, 0.723; 95% CI, 0.59-0.91; P < .0022) among 270 patients with recurrent or progressive metastatic urothelial carcinoma who had failed platinum-based chemotherapy.

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If approved, pembrolizumab would be the third immune checkpoint inhibitor indicated for the treatment of patients with urothelial carcinoma.