US regulators have expanded the scope of AstraZeneca/MedImmune’s immunotherapy Imfinzi to include patients with a certain form of lung cancer.
The US Food and Drug Administration is allowing the drug’s use to treat unresectable Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed following platinum-based chemoradiation therapy.
Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, already has an accelerated approval for the treatment of certain patients with locally-advanced or metastatic urothelial carcinoma.
Its clearance for Stage III lung NSCLC widens treatment options for patients and could potentially improve outcomes, given that the current standard of care is active monitoring following concurrent chemoradiation.
“Globally, approximately 30 percent of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting,” noted Dave Fredrickson, head of the Oncology Business Unit at AZ.
Clearance was issued after data from the Phase III PACIFIC trial showed an 11.2-month improvement in median progression-free survival in patients taking the drug versus placebo (16.8 months versus 5.6 months respectively).
Given that up to 89 percent of patients with Stage III NSCLC will progress to metastatic disease, “it is important that there is now a new option that can give patients more time without disease progression,” said Scott Antonia, chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and investigator in the PACIFIC trial.
“The PACIFIC trial data supporting [the] approval of Imfinzi will change how we treat these patients.”
The indication is also currently under review in Europe.
