Jyoti S. Mayadev, MD, on Pembrolizumab/CRT FDA Approval in Cervical Cancer
Season 1, Episode 93, Jan 22, 02:00 PM
In a conversation with CancerNetwork® prior to the FDA approval of pembrolizumab (Keytruda) plus chemoradiotherapy in FIGO stage III to IVA cervical cancer, Jyoti S. Mayadev, MD, spoke about how the regimen’s approval would be a “major step” for the aforementioned population and how she planned to integrate it into her care.1
Mayadev, a board-certified radiation oncologist and professor of radiation medicine and applied sciences at the University of California, San Diego School of Medicine, stated that the approval would be a “huge win” with respect to progression-free survival (PFS) based on supporting findings from the phase 3 KEYNOTE-A18 trial (NCT04221945). According to data presented at the 2023 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS), treatment with pembrolizumab plus chemoradiotherapy produced a significant PFS benefit compared with chemoradiation alone (HR, 0.70; 95% CI, 0.55-0.89; P = .0020).2 Additionally, findings from a subgroup analysis highlighted that the PFS benefit with the pembrolizumab-based combination extended to those with FIGO stage III to IVA disease (HR, 0.58; 95% CI, 0.42-0.80).1
Mayadev, a board-certified radiation oncologist and professor of radiation medicine and applied sciences at the University of California, San Diego School of Medicine, stated that the approval would be a “huge win” with respect to progression-free survival (PFS) based on supporting findings from the phase 3 KEYNOTE-A18 trial (NCT04221945). According to data presented at the 2023 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS), treatment with pembrolizumab plus chemoradiotherapy produced a significant PFS benefit compared with chemoradiation alone (HR, 0.70; 95% CI, 0.55-0.89; P = .0020).2 Additionally, findings from a subgroup analysis highlighted that the PFS benefit with the pembrolizumab-based combination extended to those with FIGO stage III to IVA disease (HR, 0.58; 95% CI, 0.42-0.80).1
Mayadev also described the tolerability and quality-of-life benefits associated with the pembrolizumab combination in the KEYNOTE-A18 trial. Additionally, she stated that potential next steps for research may involve integrating adaptive technology to potentially reduce toxicity following chemoradiation among patients with cervical cancer.
“Uptake of any new agent requires a multidisciplinary team approach. It requires workflows,” Mayadev said regarding her strategy for adopting the newly approved regimen in her clinic. “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 15, 2024. https://bit.ly/3NZNGPb
2. Lorusso D, Xiang Y, Hasegawa K, et al. ENGOT-cx11/GOG-3047/KEYNOTE-A18: A randomized, double-blind, phase 3 study of pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer. Presented at 2023 Annual Global Meeting of the International Gynecologic Cancer Society; November 5-7, 2023; Seoul, South Korea. Abstract SE004/1614.
2. Lorusso D, Xiang Y, Hasegawa K, et al. ENGOT-cx11/GOG-3047/KEYNOTE-A18: A randomized, double-blind, phase 3 study of pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer. Presented at 2023 Annual Global Meeting of the International Gynecologic Cancer Society; November 5-7, 2023; Seoul, South Korea. Abstract SE004/1614.