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Adding pembrolizumab to standard chemoradiotherapy for high-risk locally advanced cervical cancer reduced progression or death by 30%, the first systemic advance in this setting since cisplatin was added to radiotherapy in 1999.
Double-blind, placebo-controlled phase 3 trial (ENGOT-cx11/GOG-3047/KEYNOTE-A18) of 1,060 patients at 176 centres in 30 countries with newly diagnosed, high-risk locally advanced cervical cancer (FIGO 2014 stage IB2-IIB with node-positive disease, or stage III-IVA) randomised 1:1 to five cycles of pembrolizumab 200 mg or placebo every three weeks with chemoradiotherapy, then 15 cycles of pembrolizumab 400 mg or placebo every six weeks. Primary endpoints were progression-free survival and overall survival.
At the first interim analysis (data cutoff 9 January 2023, median follow-up 17.9 months) median progression-free survival was not reached in either group; the 24-month rate was 68% with pembrolizumab against 57% with placebo (HR 0.70, p=0.0020). Overall survival at 24 months was 87% against 81% (HR 0.73), not yet significant at this analysis. A second Lancet report later in 2024 confirmed the overall survival gain.
Women with locally advanced cervical cancer that is node-positive or stage III-IVA can be offered pembrolizumab alongside and after chemoradiotherapy to lower the chance of relapse. The result matters most in countries where cervical cancer is common but immunotherapy access is poorest, so its global impact depends on pricing and health-system capacity. It does not apply to early-stage disease treated with surgery or to lower-risk locally advanced disease without nodal involvement.
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.