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FDA grants priority review to Imfinzi for advanced non-small cell lung cancer
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The FDA granted priority review to durvalumab for the treatment of patients with locally advanced unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.
The supplemental biologics license application included positive PFS data from the randomized, double-blind, placebo-controlled multicenter phase 3 PACIFIC trial of durvalumab (Imfinzi; AstraZeneca, MedImmune), a human monoclonal antibody directed against PD-L1.
PFS and OS served as the primary endpoints. Secondary endpoints included landmark PFS and OS, objective response rate and duration of response.
In the trial — conducted at 235 centers in 26 countries — researchers randomly assigned patients 2:1 to receive 10 mg/kg durvalumab via IV every 2 weeks (n = 473) or placebo (n = 236). Treatment continued for up to 1 year.
As HemOnc Today previously reported, durvalumab-treated patients achieved significantly longer median PFS (16.8 months vs. 5.6 months; HR = 0.52; 95% CI, 0.42-0.65).
Researchers also reported higher rates of 12-month PFS (55.9% vs. 35.3%), 18-month PFS (44.2% vs. 27%) and ORR (28.4% vs. 16%; P < .001) in the durvalumab group.
Median time to death or distant metastasis also was longer among durvalumab-treated patients (23.2 months vs. 14.6 months; stratified HR = 0.52; 95% CI, 0.39-0.69).
The trial continues to evaluate OS.