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The second report from KEYNOTE-A18 showed that adding pembrolizumab to chemoradiotherapy for high-risk locally advanced cervical cancer also lengthened life: 82.6% of women were alive at three years against 74.8%, a third fewer deaths.
Second interim analysis of the double-blind, placebo-controlled phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 trial, in which 1,060 patients with newly diagnosed, high-risk locally advanced cervical cancer (FIGO 2014 stage IB2-IIB node-positive or stage III-IVA) were randomised to pembrolizumab or placebo with cisplatin-based chemoradiotherapy followed by pembrolizumab or placebo maintenance.
At data cutoff on 8 January 2024 (median follow-up 29.9 months) median overall survival was not reached in either group; 36-month overall survival was 82.6% with pembrolizumab against 74.8% with placebo, hazard ratio for death 0.67 (p=0.0040), meeting the primary objective. Grade 3 or higher adverse events occurred in 78% and 70% of patients, and potentially immune-mediated adverse events in 39% and 17%. Together with the progression-free survival report it established immuno-chemoradiotherapy as a new standard of care for this population.
The survival gain turns the earlier progression-free survival result into a clear reason to offer pembrolizumab with and after chemoradiotherapy to women with node-positive or stage III-IVA cervical cancer. Because cervical cancer is concentrated in low- and middle-income countries, the benefit reaches most women only if pricing and access follow.
Shares Giovanni Scambia, Domenica Lorusso, HPV circulating tumour DNA to guide cervical cancer therapy, Policlinico Universitario A. Gemelli.
Shares KEYNOTE-A18 / ENGOT-cx11 / GOG-3047, Locally advanced cervical cancer, Brachytherapy, Cervical cancer.
Shares Combined positive score (CPS), Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.
Shares Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy, The Lancet.
Shares Giovanni Scambia, Policlinico Universitario A. Gemelli, Progression-free survival (PFS), Overall survival (OS).
Shares Combined positive score (CPS), Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.
Shares Standard of care, Progression-free survival (PFS), Overall survival (OS), The Lancet.
Shares Standard of care, Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.