Pembrolizumab/Chemoradiotherapy Approval is ‘Huge Win’ in Cervical Cancer

The FDA approval of pembrolizumab (Keytruda) plus chemoradiotherapy for those with FIGO 2014 stage III to IVA cervical cancer should be considered a “huge win” based on its progression-free survival (PFS) benefit as reported in the phase 3 KEYNOTE-A18 trial (NCT04221945), said Jyoti S. Mayadev, MD.¹

In an interview with CancerNetwork^® ahead of the regimen’s approval, Mayadev, a board-certified radiation oncologist and professor of radiation medicine and applied sciences at the University of California, San Diego School of Medicine, spoke about how findings from the KEYNOTE-A18 trial presented at the 2023 European Society for Medical Oncology Congress (ESMO) support the pembrolizumab combination’s efficacy in the aforementioned patient population.²

Data from the study highlighted both a statistically significant PFS benefit in the overall study population over placebo and chemoradiotherapy. Moreover, in a subgroup analysis, investigators reported that among patients with FIGO stage III to IVA disease (n = 596), 21% in the pembrolizumab arm experienced a PFS event vs 31% in the placebo arm (HR, 0.59; 95% CI, 0.43-0.82).¹

Following the regimen’s approval, Mayadev stated that her institution would seamlessly adopt it into clinical practice while organizing an effort to help the gynecologic oncology community incorporate the combination into the management of cervical cancer.

Transcript:

This would be a huge win for patients in terms of improving progression-free survival, and hopefully overall survival. A lot of this is really on the notion of the presentation that was given at ESMO this year for KEYNOTE-A18, really showing a progression free survival benefit of 68% [with pembrolizumab plus chemoradiation] over 57% [with placebo plus chemoradiation at 24 months] in patients with locally advanced cervical cancer.

Uptake of any new agent requires a multidisciplinary team approach. It requires workflows. We, in our institution, have participated in novel agent trials with chemoradiation, so we would look to the FDA approvals and the NCCN guidelines. We already have methods of incorporating novel agents and immunotherapy in our workflow with chemoradiation for locally advanced cervical cancer. For our particular institution, we would somewhat seamlessly go into the FDA approval. At the same time, we would try to help others in the community. We, as a scientific global community for gynecologic oncology and radiation oncology, will come together and start to incorporate how we can move forward with the FDA approval.

References

1. FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 stage III-IVA cervical cancer. News release. January 12, 2024. Accessed January 12, 2024. https://bit.ly/3NZNGPb
2. Lorusso D, Xiang Y, Hasegawa K, et al. Pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer: a randomized, double-blind, phase III ENGOT-cx11/GOG-3047/ KEYNOTE-A18 study Ann Oncol. 2023;34(S2):S1279-S1280. doi:10.1016/j.annonc.2023.10.032