Patients with advanced non-small cell lung cancer (NSCLC) who have not progressed after receiving standard of care therapy may experience a significant prolongation of progression-free survival (PFS) if treated with durvalumab compared with placebo, according to a study published in The New England Journal of Medicine.1
Patients with stage III NSCLC have a poor median PFS of 8 months despite achieving a good response to the current standard of care of platinum-based double chemotherapy with concurrent radiotherapy, indicating the need for further research and improvement for this population. In the phase 3 PACIFIC trial (ClinicalTrials.gov Identifier: NCT02125461), investigators randomly assigned 713 patients 2:1 to receive intravenous durvalumab 10 mg/kg consolidation therapy or placebo every 2 weeks for up to 1 year.
Patients who received durvalumab had a median PFS of 16.8 months (95% CI, 13.0-18.1) compared with 5.6 months (95% CI, 4.6-7.8) in patients who received placebo (hazard ratio [HR], 0.52; 95% CI, 0.42-0.65; P < .001).
The PFS rate at 12 months was 55.9% and 35.3%, and the 18 month PFS rate was 44.2% and 27.0% in patients who received durvalumab and placebo, respectively.
Patients who received durvalumab had a greater response rate with 28.4% compared with 16.0% in patients receiving placebo (P < .001), and the median duration of response was longer in the durvalumab arm (72.8% vs 46.8% of patients maintained ongoing response at 18 months).
The median time to death or distant metastasis was more prolonged in the durvalumab arm than with the placebo arm (23.2 months vs 14.6 months; P < .001).
The most frequently reported grade 3 to 4 adverse event (AE) was pneumonia, which occurred in 4.4% and 3.8% of patients who received durvalumab and placebo, respectively. Approximately 30% of patients in the durvalumab arm and 26% in the placebo arm reported having a grade 3 to 4 AE. The rate of discontinuation due to AE was 15.4% in the durvalumab arm and 9.8% in the placebo arm.
The authors of the study concluded that “durvalumab may be an effective adjuvant therapy in patients with stage III disease after standard treatment. Uncertainty about the potential mechanisms driving the interaction between immunotherapy and chemoradiotherapy warrants further investigation.”
1. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non–small-cell Lung Cancer [published online September 5, 2017]. N Eng J Med. doi: 10.1056/NEJMoa1709937