FDA Approves Pembrolizumab Combination to Treat First-Line Cervical Cancer


Pembrolizumab is approved both in combination with chemotherapy, with or without bevacizumab, and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer.

The FDA approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab (Avastin), to treat patients with persistent, recurrent, or metastatic cervical cancer whose tumors harbor PD-L1, as demonstrated by an FDA-approved test, according to a press release issued by the agency.1

Notably, the FDA has also granted regular approval to pembrolizumab as a monotherapy for the same patient population on or after chemotherapy. The agency granted this indication an accelerated approval, with its companion diagnostic, PD-L1 IHC 22C3 pharmDx, in June 2018.

This approval was based on findings from the multicenter, randomized, double-blind, placebo-controlled, phase 3 KEYNOTE-826 trial (NCT03635567). Findings from the trial’s interim analysis were recently presented at the 2021 ESMO Congress.2

The trial assessed 617 patients with persistent, recurrent, or first-line metastatic cervical cancer who had not been treated with chemotherapy, irrespective of PD-L1 expression status. Participants were randomized into 2 treatment cohorts: The experimental cohort received pembrolizumab 200 mg plus chemotherapy with or without bevacizumab, while the control cohort received placebo plus chemotherapy with or without bevacizumab. Pembrolizumab was administered until disease progression, unacceptable toxicity, or 24 months of treatment.

The trial’s primary end points were overall survival (OS) and progression-free survival (PFS) as determined by RECIST v1. With a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Median OS was not reached in the pembrolizumab arm (95% CI, 19.8-not reached [NR]) and was 16.3 months (95% CI, 14.5-19.4) in the placebo arm (HR, 0.64; 95% CI, 0.50-0.81; .P = 0.0001). Median PFS was 10.4 months in the experimental arm (95% CI, 9.7-12.3) and 8.2 months in the control arm (95% CI, 6.3-8.5), respectively (HR, 0.62; 95% CI, 0.50-0.77; P < .0001).

Objective response rates were 68% in the experimental group and 50% in the control. In addition, patients taking pembrolizumab experienced a median DOR of 18.0 months, compared with 10.4 months in the pembrolizumab arm.

“Adding pembrolizumab to chemotherapy with or without bevacizumab provides statistically significant, clinically meaningful improvements in PFS and OS in patients with persistent, recurrent, or metastatic cervical cancer. The significant benefit was observed in all primary analysis populations and was generally consistent across protocol-specified subgroups,” lead study author Nicoletta Colombo, MD, PhD, director of the Gynecologic Oncology Division at the European Institute of Oncology and associate professor of Obstetrics and Gynecology at the University of Milan-Bicocca in Milan, Italy, said in a recent presentation of the findings. “Overall, data from KEYNOTE-826 suggest that pembrolizumab plus platinum-based chemotherapy with or without bevacizumab may be a new first-line standard of care for the treatment [of these patients].”

The most common adverse events (AEs) observed in the experimental arm included peripheral neuropathy, alopecia, anemia, fatigue/asthenia, nausea, neutropenia, diarrhea, hypertension, thrombocytopenia, constipation, arthralgia, vomiting, urinary tract infection, rash, leukopenia, hypothyroidism, and decreased appetite.

Pembrolizumab should be administered at 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months.


  1. FDA approves pembrolizumab combination for the first-line treatment of cervical cancer. News release. FDA. October 13, 2021. Accessed October 13, 2021. https://bit.ly/3lE3vNS

  • Colombo N, Dubot C, Lorusso D, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for persistent, recurrent, or metastatic cervical cancer: randomized, double-blind, phase 3 KEYNOTE-826 study. Presented at: 2021 ESMO Congress; September 16-21, 2021; virtual. Abstract LBA2_PR

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