Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial - Nature Medicine

for full study protocol). This manuscript reports results from EMPOWER-Lung 3 part two, which compared cemiplimab plus chemotherapy versus placebo plus chemotherapy in patients with aNSCLC and any PD-L1 expression level. The time point for primary analysis has been reached for part two, and the results are reported here.

Patients reserved the right to withdraw from the study at any time for any reason. Criteria for discontinuation of treatment included toxicity that did not resolve within 84 days of last treatment infusion; any severe or life-threatening event; pregnancy; and a grade ≥3 infusion reaction during or directly after treatment infusions.

All efficacy endpoints were assessed in the intention-to-treat population. Safety was assessed in all randomized patients who received at least one dose of the assigned treatment. All patients provided written informed consent before enrollment. The study was sponsored by Regeneron Pharmaceuticals and Sanofi and was designed by employees of Regeneron Pharmaceuticals in collaboration with the investigators.

It is seen that it provides an overall survival advantage in the PD-L11% group, not independent of PD-L1 level.

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