Pembrolizumab Granted FDA Approval for PD-L1+ Cervical Cancer

Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA for the treatment of patients with advanced, PD-L1–positive cervical cancer with disease progression on or after chemotherapy.

The approval is based on data from 98 patients with recurrent or metastatic cervical cancer enrolled in a single cohort in the phase II KEYNOTE-158 trial. The global, open-label, nonrandomized, multicohort, multicenter study evaluated pembrolizumab in patients with multiple types of advanced solid tumors who progressed on standard of care therapy.

At a median follow-up of 11.7 months (range, 0.6-22.7), the overall response rate (ORR) was 14.3% (95% CI, 7.4-24.1) in 77 PD-L1–positive patients (CPS ≥1) previously treated with ≥1 line of chemotherapy in the metastatic setting. The ORR comprised a complete response rate of 2.6% and a partial response rate of 11.7%. The median duration of response was not reached (range, 4.1-18.6+), and 91% of responders had a response duration of 6 months or longer.

There were no responses reported for patients with PD-L1 expression of CPS <1.

Among the 77 PD-L1–positive patients, the median age was 45 years (range 27-75), 32% had an ECOG performance status (PS) of 0, and 68% had an ECOG PS of 1. Eighty-one percent of patients were white, 14% were Asian, and 3% were black. Thirty-five percent of patients had 1 prior line of treatment for recurrent or metastatic disease, and 65% had ≥2 prior lines.

Regarding histology, 92% had squamous cell carcinoma, 6% had adenocarcinoma, and 1% had adenosquamous carcinoma. Ninety-five percent of patients had M1 disease and 5% had recurrent disease. PD-L1 status was determined using the PD-L1 IHC 22C3 pharmDx Kit.

The accelerated approval for pembrolizumab in this setting is contingent on the results of a confirmatory trial.

Pembrolizumab has additional approved indications in melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial carcinoma, gastric cancer, and microsatellite instability–high solid tumors.