Dr. Monk on the FDA Approval of Pembrolizumab in Cervical Cancer

Bradley J. Monk, MD
Published: Tuesday, Jun 12, 2018



Bradley J. Monk, MD, FACOG, FACS, professor, director of the Division of Gynecologic Oncology at Creighton University School of Medicine at St. Joseph’s Hospital and Medical Center in Phoenix, Arizona, discusses the FDA approval of pembrolizumab (Keytruda) for the treatment of advanced cervical cancer with disease progression on or after chemotherapy.

The approval is based on findings from the phase II KEYNOTE-158 trial, which investigated pembrolizumab in patients with a range of advanced solid tumors who progressed on standard therapy.

Results showed that, at a median follow-up of 11.7 months (range, 0.6-22.7), the overall response rate was 14.3% (95% CI, 7.4-24.1) in 77 PD-L1–positive patients previously treated with more than 1 line of chemotherapy in the metastatic setting. This also included a complete response rate of 2.6% and a partial response rate of 11.7%. Moreover, the median duration of response was not reached, and 91% of responders had a response duration of 6 months or longer.
 


Bradley J. Monk, MD, FACOG, FACS, professor, director of the Division of Gynecologic Oncology at Creighton University School of Medicine at St. Joseph’s Hospital and Medical Center in Phoenix, Arizona, discusses the FDA approval of pembrolizumab (Keytruda) for the treatment of advanced cervical cancer with disease progression on or after chemotherapy.

The approval is based on findings from the phase II KEYNOTE-158 trial, which investigated pembrolizumab in patients with a range of advanced solid tumors who progressed on standard therapy.

Results showed that, at a median follow-up of 11.7 months (range, 0.6-22.7), the overall response rate was 14.3% (95% CI, 7.4-24.1) in 77 PD-L1–positive patients previously treated with more than 1 line of chemotherapy in the metastatic setting. This also included a complete response rate of 2.6% and a partial response rate of 11.7%. Moreover, the median duration of response was not reached, and 91% of responders had a response duration of 6 months or longer.
 

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Clinical Interchange™: Translating Research to Inform Changing Paradigms: Assessment of Emerging Immuno-Oncology Strategies and Combinations across Lung, Head and Neck, and Bladder CancersOct 31, 20182.0
Oncology Best Practice™: Expert Perspectives to Incorporate Evidence on PARP Inhibitors into Practice and Optimize the Medical Management of Ovarian CancerOct 31, 20181.0
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