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Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: Results from the phase II KEYNOTE-158 study

Journal of Clinical Oncology Apr 08, 2019

Chung HC, et al. - From a phase 2 basket study (KEYNOTE-158) in which researchers evaluated the antitumor activity and safety of pembrolizumab in multiple cancer types, interim results from patients with previously treated advanced cervical cancer were revealed. Pembrolizumab 200 mg was administered to patients every 3 weeks for 2 years or until progression, intolerable toxicity, or physician or patient decision. The estimated objective response rate (ORR) was 12.2% in 98 treated patients. Three complete and nine partial responses were reported. Overall 65.3% of patients suffered treatment-related adverse events, with hypothyroidism (10.2%), decreased appetite (9.2%), and fatigue (9.2%) being the most common. In patients with advanced cervical cancer, durable antitumor activity and manageable safety profile of pembrolizumab monotherapy were evident. Considering these outcomes, pembrolizumab was granted accelerated approval by the US Food and Drug Administration for patients with advanced PD-L1–positive cervical cancer who experienced progression during or after chemotherapy.

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