FDA Approves Pembrolizumab Plus Chemo as First-Line Therapy for Advanced, Recurrent Cervical Cancer

The US Food and Drug Administration (FDA) has approved the checkpoint inhibitor pembrolizumab (Keytruda, Merck) alongside standard chemotherapy — with or without bevacizumab — as first-line therapy for patients with persistent, recurrent, or metastatic PD-L1-expressing cervical cancer.

The first-line approval comes on the heels of the phase 3 results from the KEYNOTE-826 trial, presented last month at the European Society for Medical Oncology (ESMO) Congress 2021.

In the same press release, the FDA also announced the regular approval of pembrolizumab alone for patients with recurrent or metastatic cervical cancer experiencing disease progression during or post-chemotherapy. The FDA had previously granted accelerated approval for this indication in June 2018, alongside the approval of a companion diagnostic test — PD-L1 IHC 22C3 pharmDx — that can detect PD-L1 expression in tumors.

According to the latest KEYNOTE-826 analysis, presented at ESMO last month, adding pembrolizumab to platinum-based chemotherapy with or without bevacizumab led to significant improvements in overall and progression-free survival in patients with recurrent, persistent, or metastatic cervical cancer.

Raza Mirza, MD, chief oncologist at Copenhagen University Hospital in Denmark, who discussed the findings at ESMO, declared the combination "the new standard of care" for cervical cancer.

The trial included 617 patients with persistent, recurrent, or metastatic cervical cancer who were randomized to receive pembrolizumab 200 mg intravenously every 3 weeks in combination with standard chemotherapy and bevacizumab, at the investigator's discretion, or placebo for up to 35 cycles.

For patients with a PD-L1 combined positive score of 1 or more, median progression-free survival was 10.4 months in the pembrolizumab group and 8.2 months in the placebo group. Progression-free survival at 12 months was 45.5% in the pembrolizumab group compared with 34.1% in the placebo group (hazard ratio [HR], 0.62; P < .001).

The researchers also reported that median overall survival was not reached in the pembrolizumab group and was 16.3 months in the placebo group. Overall survival rates at 12 and 24 months were higher in the pembrolizumab group — 75.3% and 53%, respectively — compared with the placebo cohort — 63.1% and 41.7%, respectively (HR, 0.61; P < .001).

Patients with a PD-L1 combined positive score of 10 or more also had better progression-free survival and overall survival with pembrolizumab. Overall survival was 75.7% at 12 months and 54.4% at 24 months with pembrolizumab versus 61.5% and 44.6% with placebo, respectively (HR, 0.61; P < .001). However, the benefit of adding pembrolizumab was not observed in patients with PD-L1-negative tumors.

According to the analysis, the most common adverse reactions, which occurred in more than one in five patients in the pembrolizumab group, included peripheral neuropathy, alopecia, anemia, fatigue, nausea, neutropenia, diarrhea, and hypertension.

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Cite this: FDA Approves Pembrolizumab Plus Chemo as First-Line Therapy for Advanced, Recurrent Cervical Cancer - Medscape - Oct 13, 2021.