KEYNOTE-A18 Eligibility: Pembro/Chemoradiotherapy in Cervical Cancer

Bradley J. Monk, MD, FACS, FACOG, gynecologic oncologist with Florida Cancer Specialists & Research Institute, discusses the enrollment criteria and dosing for the phase 3 KEYNOTE-A18 study (NCT04221945) which evaluated the addition of pembrolizumab (Keytruda) to external beam radiotherapy and concurrent chemotherapy, followed by brachytherapy for the treatment of patients with newly diagnosed, previously untreated, high-risk locally advanced cervical cancer.

Transcription:

0:10 | The criteria are clear, but it's the context of the meaning of the result that is not. I have a history of designing trials for patients that are at higher-risk. There's no such thing as low-risk. If you look at the PARP inhibitor trial that we did called PRIMA [NCT02655016] with niraparib [Zejula], that was [with patients who were] high-risk, stage III and IV. If you look at the RUBY study [NCT03981796] adding dostarlimab [Jemperli] to chemotherapy in endometrial cancer, that was higher-risk patients, but the approval in both PRIMA and niraparib in ovarian [cancer] was all comer because there's no such thing as low-risk. The approval for RUBY of dostarlimab in endometrial cancer was all advanced and metastatic. Both of those studies, PRIMA and RUBY, have now FDA-approved medicines for patients that were not eligible for this study.

0:57 | Now for [KEYNOTE-A18], it was high-risk, locally advanced cervical cancer, but there's no such thing as a low-risk patient who has a tumor like this, that can't be resected. So in order to be enrolled, you had to have stage III, the old staging, so sidewall involvement, or hydronephrosis, or at least 2 positive nodes. It will be interesting to see if the FDA follows suit, and does what they did in PRIMA and RUBY to now cervical cancer in [KEYNOTE-A18]. And why is this relevant? Because the patients who get cervical cancer are of a different demographic. More than half of the patients enrolled in [KEYNOTE-A18] are not White. I hope that the FDA sort of follows their consistency and allows this to get reimbursed for all women that have locally advanced cervical cancer, not just the high-risk because there's no such thing.