FDA Approval of Durvalumab for Stage III Unresectable NSCLC

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The FDA has approved the PD-L1 inhibitor durvalumab (Imfinzi) for the treatment of patients with stage III, unresectable non-small cell lung cancer. The indication is for patients whose disease has not progressed following platinum-based chemoradiation therapy.

The decision was based on positive progression-free survival (PFS) results from the phase III PACIFIC trial, in which the median PFS from randomization showed an 11.2-month benefit associated with durvalumab versus placebo at 16.8 months vs 5.6 months, respectively. The 12-month PFS rate was 55.9% versus 35.3%, and the 18-month PFS rate was 44.2% versus 27.0%, again favoring the durvalumab arm.

Investigators found a PFS benefit associated with durvalumab was consistent across all pre-specified subgroups, and the PFS benefit was also held irrespective of PD-L1 expression before chemoradiotherapy.

Objective response rate was also significantly higher with durvalumab at 28.4% vs 16.0% with placebo. In addition, 16.5% of patients in the durvalumab group experienced disease progression compared with 27.7% of the placebo arm.

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