Mature Data From KEYNOTE-826 Study of Pembrolizumab Addition in Cervical Cancer

Bradley J. Monk, MD, FACS, FACOG, professor, division of gynecologic oncology, University of Arizona College of Medicine, Creighton University School of Medicine, director, principal investigator, community research development, HonorHealth Research Institute, vice president and member board of directors GOG-Foundation, co-director GOG-partners, discusses findings from the phase 3 KEYNOTE-826 trial (NCT03635567).

In the study, pembrolizumab (Keytruda) added to chemotherapy with or without bevacizumab (Avastin) was evaluated as a first-line treatment for patients with persistent, recurrent, or metastatic cervical cancer.

Significant survival benefits were observed in the study, according to Monk, including an overall survival rate of 28.6 months with the addition of pembrolizumab vs 16.5 months among patients treated with the placebo who had a PD-L1 combined positive score of 1 or higher.

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0:10 | At the time of the interim analysis, follow-up was less than 2 years, and the medians had not been met. Statistically, the hazard ratio was 0.64, and that's why it got FDA-approved. The therapy that pembrolizumab was added to was platinum and taxane-based chemotherapy with and without bevacizumab.

0:39 | Bevacizumab was approved in 2014 and we have had nothing since. When pembrolizumab is added to chemotherapy with or without bevacizumab, women, who are on average around 48-50 years of age, live a year longer. These are young women who now are living longer because of research that was done by the investigators and by patients and their families who contributed, and a sponsor who makes pembrolizumab. This is a transformational result. This is not changing a CAT scan, what we call progression-free survival. This is changing a woman's life. The more intensive therapy helps her live 12.1 months longer with a hazard ratio of 0.60 and doesn't decay her quality-of-life.

1:39 | We published in April of 2023 in the Lancet Oncology that there was no decrease in patient reported outcomes or quality-of-life. In fact, there were numerical increases in quality-of-life. Patients are living longer and they're living better. That is the definition of clinical trials. That's why we as investigators get up in the morning. At a time, maybe 20 years ago, where we had no treatment for women with persistent recurrent or stage IVB cervical cancer, we developed chemotherapy, we added bevacizumab to it, and now we have quadruplet therapy where women on average can live 28.6 months, which means that 50% live longer.