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R. Wendel Naumann, MD, FACOG, FACS, discusses how the evolution of immunotherapy has changed the treatment landscape for patients with recurrent or metastatic cervical cancer.
R. Wendel Naumann, MD, FACOG, FACS, professor, director, Gynecologic Oncology Research, associate medical director, Clinical Trials, Levine Cancer Institute, Atrium Health, discusses how the evolution of immunotherapy has changed the treatment landscape for patients with recurrent or metastatic cervical cancer.
The use of immunotherapy agents for cervical cancer is a moving target, and the role of these agents continues to change as they are investigated in earlier lines of therapy, Naumann begins.
In October 2021, the FDA approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab(Avastin), for use in patients with persistent, recurrent or metastatic, PD-L1–positive cervical cancer. This approval was based on data from the phase 3 KEYNOTE-826 trial (NCT03635567).Prior to this approval, single-agent pembrolizumab also received accelerated approval for patients in this population who experienced disease progression on or after prior chemotherapy in June 2018.
The approval of the combination indicates the success of checkpoint inhibitor–based combinations in cervical cancer, Naumann says. However, now that pembrolizumab has moved to the frontlinesetting, there is a lack of effective therapies for patients who progress on this regimen, he notes. Research efforts should aim to address this unmet need in the future.
The tissue factor-directed antibody-drug conjugate tisotumab vedotin-tftv (Tivdak) received accelerated approval in September 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, Naumann continues. Approval for this agent was supported by findings from the single-arm, phase 2 innovaTV 204 trial (NCT03438396). This drug is a viable option for patients in the second-line setting and may provide some benefit. However, this agent may eventually be combined with PD-L1 inhibitors for use in the frontline setting.
The continued development of novel immunotherapy combinations for patients with cervical cancer may provide less toxic alternatives to regimens that include paclitaxel, Naumann continues. This agent is associated with several adverse effects, such as joint achesand hair loss that negatively affect quality of life for women with cervical cancer, Naumann concludes.
Disclosures: Dr Naumann reports serving as a consultant or in an advisory role for Agenus, AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, OncoMed, Eisai, GlaxoSmithKline/Tesaro, GOG Partner, Merck Sharp & Dohme, Seattle Genetics, Sutro Biopharma; he served on a Data Safety and Monitoring Board for Genelux (GOG 3076/OnPrime), Laekna Therapeutics,GOG for Intuitive (GOG 3043/ROCC); he served on a Speakers' Bureau for Seattle Genetics; he received institutional research funding from Bristol-Myers Squibb, OncoMed, GlaxoSmithKline/Tesaro, Gynecologic Oncology Group, Mersana, and Sutro Biopharma.