FDA Approves Durvalumab for Prevention of NSCLC Progression
The FDA based its approval on positive findings from the phase 3 PACIFIC study.
The US Food and Drug Administration (FDA) expanded durvalumab's indication to include patients with unresectable stage III non–small cell lung cancer (NSCLC) whose disease has not progressed after chemoradiotherapy (CRT), according to a press release.1
The FDA based its approval on positive findings from the phase 3 PACIFIC study (ClinicalTrials.gov Identifier: NCT02125461), for which researchers randomly assigned 713 patients with NSCLC without disease progression after CRT to receive durvalumab 10 mg/kg or placebo.
Patients in the durvalumab arm had a median progression-free survival (PFS) of 16.8 months (95% CI, 13.0-18.0) vs 5.6 months (95% CI, 4.6-7.8) in the placebo arm (stratified hazard ratio for disease progression or death, 0.52; 95% CI, 0.42-0.65; P < .001). The 12-month PFS rate was 55.9% vs 35.3%, respectively, and the 18-month PFS rate was 44.2% vs 27.0% for patients treated with durvalumab vs placebo.2
Grade 3 to 4 adverse events (AE) occurred in 30% of patients in the durvalumab arm and 26% among patients receiving placebo; the most frequently reported grade 3 to 4 AE was pneumonia.
About 15% of patients receiving durvalumab discontinued treatment because of an AE compared with 10% of patients treated with placebo.
- FDA expands approval of Imfinizi to reduce the risk of non-small cell lung cancer progressing [press release]. Silver Spring, MD: US Food and Drug Administration; February 16, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597217. Accessed February 20, 2018.
- Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non-small-cell lung cancer. N Engl J Med. 2017;377:1919-29.