Immunotherapy

KEYNOTE-A18 (NCT04221945) was a multicenter, phase III, randomized trial that included 1,060 women with newly diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix. Patients had stage IB2 or IIB node-positive disease or stage III to IVA disease and had received no prior treatment. Patients were randomly assigned to receive either chemoradiation therapy (with cisplatin) plus pembrolizumab (every 3 weeks for five cycles) or chemoradiation therapy plus placebo. All patients received maintenance therapy with pembrolizumab or placebo every 6 weeks for 15 cycles. All patients received brachytherapy, and 94% of patients had programmed death-ligand 1 (PD-L1)–positive disease. The dual primary end points were progression-free survival (PFS) and OS. The median follow-up time was 17.9 months.[33]

KEYNOTE-A18 (NCT04221945) was a multicenter, phase III, randomized trial that included 1,060 women with newly diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix. Patients had stage IB2 or IIB node-positive disease or stage III to IVA disease and had received no prior treatment. Patients were randomly assigned to receive either chemoradiation therapy (with cisplatin) plus pembrolizumab (every 3 weeks for five cycles) or chemoradiation therapy plus placebo. All patients received maintenance therapy with pembrolizumab or placebo every 6 weeks for 15 cycles. All patients received brachytherapy, and 94% of patients had programmed death-ligand 1 (PD-L1)–positive disease. The dual primary end points were progression-free survival (PFS) and OS. The median follow-up time was 17.9 months.[33]

The 24-month OS rate was 87% in the pembrolizumab group and 81% in the placebo group (HR, 0.73; 95% CI, 0.49–1.07).[33][Level of evidence B1]

KEYNOTE-A18 (NCT04221945) was a multicenter, phase III, randomized trial that included 1,060 women with newly diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix. Patients had stage IB2 or IIB node-positive disease or stage III to IVA disease and had received no prior treatment. Patients were randomly assigned to receive either chemoradiation therapy (with cisplatin) plus pembrolizumab (every 3 weeks for five cycles) or chemoradiation therapy plus placebo. All patients received maintenance therapy with pembrolizumab or placebo every 6 weeks for 15 cycles. All patients received brachytherapy, and 94% of patients had programmed death-ligand 1 (PD-L1)–positive disease. The dual primary end points were progression-free survival (PFS) and OS. The median follow-up time was 17.9 months.[33]

There was a statistically significant improvement in PFS (HR, 0.70; 95% CI, 0.55–0.89). The 24-month PFS rate was 68% in the pembrolizumab group and 57% in the placebo group.

KEYNOTE-A18 (NCT04221945) was a multicenter, phase III, randomized trial that included 1,060 women with newly diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix. Patients had stage IB2 or IIB node-positive disease or stage III to IVA disease and had received no prior treatment. Patients were randomly assigned to receive either chemoradiation therapy (with cisplatin) plus pembrolizumab (every 3 weeks for five cycles) or chemoradiation therapy plus placebo. All patients received maintenance therapy with pembrolizumab or placebo every 6 weeks for 15 cycles. All patients received brachytherapy, and 94% of patients had programmed death-ligand 1 (PD-L1)–positive disease. The dual primary end points were progression-free survival (PFS) and OS. The median follow-up time was 17.9 months.[33]

Patients with stage III or IV disease had a greater improvement in PFS (HR, 0.58; 95% CI, 0.42–0.80).