The European Medicines Agency (EMA) has accepted for review a marketing authorization application to approve Imfinzi (durvalumab) to treat patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiotherapy.
The EMA’s acceptance of the submission is a milestone for Imfinzi and the NSCLC patient community, for whom standard-of-care treatment after chemoradiation therapy is only active monitoring.
The submission was grounded on positive progression-free survival (PFS) data from the Phase 3 PACIFIC clinical trial (NCT02125461), a randomized, double-blinded, placebo-controlled, multi-center study of Imfinzi as a consolidation therapy, or as a drug used to kill any cancer cells that may be left in the body after prior treatment.
PACIFIC involved 700 participants, according to a press release. All were NSCLC patients whose cancers had not progressed following platinum-based chemoradiotherapy — a type of treatment that combines chemo with radiation therapy, also called chemoradiation.
The study, “Durvalumab after Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer,” appeared online in the New England Journal of Medicine.
Imfinzi is an anti-PD-L1 (programmed death ligand-1) antibody, a kind of drug called a checkpoint inhibitor. As such, Imfinzi unblocks the immune system, allowing it to fight cancer. Imfinzi is an immunotherapy, meaning it stimulates the body’s own immune system to attack tumorous cells.
Results suggest that Imfinzi was able to increase time to disease progression in patients with advanced NSCLC who had not progressed after standard-of-care treatment with platinum-based concurrent chemoradiotherapy.
When compared to placebo, Imfinzi reduced the risk of disease progression by 48 percent. Median progression-free survival with Imfinzi was 16.8 months, versus 5.6 months with placebo. Adverse events were similar in each case, suggesting a favorable safety profile.
Based on the PACIFIC trial results the U.S. Food and Drug Administration granted Imfinzi breakthrough therapy designation in July 2017. That designation aims to spur development and review of drugs that may offer more hope than those currently available for patients with serious diseases.