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Durvalumab Approaches EU Approval for Locally Advanced PD-L1+ NSCLC

Jason M. Broderick @jasoncology
Published: Friday, Jul 27, 2018

Sean Bohen, MD, PhD

Sean Bohen, MD, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of durvalumab (Imfinzi) for the treatment of patients with locally advanced, unresectable stage III non–small cell lung cancer (NSCLC) who have not progressed following chemoradiotherapy and whose tumors express PD-L1 on ≥1% of tumor cells.

The most frequent AEs leading to discontinuation were pneumonitis or radiation pneumonitis and pneumonia in both groups. One-third of patients assigned to durvalumab experienced any-grade pneumonitis or radiation pneumonitis compared with 24.8% in the placebo group. Grade 3/4 pneumonitis or radiation pneumonitis occurred in 3.4% of the durvalumab group and 2.6% of the placebo group. Deaths due to AEs occurred in 4.4% of patients in the durvalumab group and 5.6% of patients in the placebo group.
Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. N Engl J Med. 2017;377(20):1919-1929 doi: 10.1056/NEJMoa1709937.

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