Keytruda (pembrolizumab) + chemoradiotherapy (CRT) reduced risk of death by 33% versus CRT alone in newly diagnosed high-risk locally advanced cervical cancer

At a median follow-up of 29.9 months (range, 12.8-43.0), Keytruda in combination with concurrent CRT reduced the risk of death by 33% (HR=0.67 [95% CI, 0.50-0.90]; p=0.0040) versus concurrent CRT alone for these patients. These data were selected for the official Press Briefing and are being presented for the first time today during a Presidential Symposium session at the European Society for Medical Oncology (ESMO) Congress 2024 (Presentation #709O) and published simultaneously in The Lancet

For patients who received the Keytruda -based regimen, the 36-month OS rate was 82.6% versus 74.8% for those who received concurrent CRT alone. Median OS was not reached in either group. The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

“Cervical cancer is one of the leading causes of cancer-related deaths for women across the globe, but treatment advances in recent years have not demonstrated a significant survival benefit for patients with high-risk, locally advanced forms of the disease,” said Dr. Domenica Lorusso, the study’s overall principal investigator, lead investigator for ENGOT and professor of Obstetrics and Gynecology at Humanitas University. “These are the first positive overall survival results for an immunotherapy-based regimen for newly diagnosed patients with high-risk locally advanced cervical cancer and have the potential to change the treatment paradigm for these patients.”

KEYNOTE-A18 is one of four Phase III studies of a Keytruda-based regimen in an earlier stage of cancer to demonstrate an OS benefit, in addition to KEYNOTE-522 in newly diagnosed, high-risk early-stage triple-negative breast cancer and KEYNOTE-671 in resectable stage II, IIIA or IIIB non-small cell lung cancer (in both studies, as treatment with chemotherapy before surgery and then as a single agent after surgery, compared to pre-operative chemotherapy), as well as KEYNOTE-564 in renal cell carcinoma for patients at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (compared to placebo).

Citation:"Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase III trial". Prof Domenica Lorusso, MD PhD.   Prof Yang Xiang, MD, .Prof Kosei Hasegawa, MD PhD , Prof Giovanni Scambia, MD , Manuel Leiva, MD MSc. Pier Ramos-Elias, MD. et al .DOI: 10.1016/S0140-6736(24)01808-7.