On February 16, 2018 the FDA approved Imfinzi® (durvalumab) as a consolidation treatment for patients with stage III non-small cell lung cancer (NSCLC) who disease has not progressed after chemoradiation therapy . Durvalumab is an anti-programmed death-ligand 1 (PD-L1) antibody that belongs to a class of drugs known as immune checkpoint inhibitors (ICIs) which work by releasing the breaks on the immune system, enabling anti-tumor immune responses. Durvalumab was initially approved by the FDA in 2017 for the treatment of patients with metastatic urothelial carcinoma who had progressed on platinum-based chemotherapy . Concurrent platinum-based chemotherapy and radiation is standard of care therapy for patients with stage III NSCLC; however, most patients eventually develop disease progression after therapy, thus consolidation is an important treatment step to improve patient outcomes.
The approval of durvalumab for NSCLC came after results of a randomized phase 3 trial showed a significant improvement in median progression free survival for patients receiving durvalumab consolidation therapy over placebo, 16.8 months versus 5.6 months, respectively . The study, PACIFIC, was conducted in 709 patients with stage III NSCLC who did not experience disease progression after two or more cycles of platinum-based chemoradiotherapy (NCT02125461) . The patients were randomized 2:1 to receive durvalumab or placebo consolidation treatment for up to 12 months. The overall response rate for patients receiving durvalumab was 28.4% and 16% for patients receiving placebo. Additionally, durvalumab improved the median time to death or distant metastasis from 14.6 months in the placebo arm to 23.2 months . The rate at which grade 3 or 4 adverse events occurred were similar between arms with 29.9% for patients who received durvalumab and 26.1% for those who received placebo . These results suggest that durvalumab can provide a significant clinical benefit as a consolidation treatment for patients with stage III NSCLC and has favorable safety profile in this patient population.
- IMFINZI® (durvalumab) injection, for intravenous use. Drugs@FDA: FDA Approved Drug Products February 16, 2018 [cited 2018 April 26]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf.
- IMFINZI™ (durvalumab) injection, for intravenous use Initial U.S. Approval: 2017 Drugs@FDA: FDA Approved Drug Products May 1, 2017 [cited 2018 April 26]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf.
- Antonia, S.J., et al., Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med, 2017. 377(20): p. 1919-1929.
- A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC). Clinicaltrials.gov January 16, 2018 [cited 2018 April 26]; Available from: https://clinicaltrials.gov/ct2/show/NCT02125461.