FDA sanctions IMFINZI for treatment of Stage III NSCLC

AstraZeneca and MedImmune proclaimed that the US FDA has approved IMFINZI  (durvalumab) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not advanced following concurrent- platinum- based chemotherpy and radiation therapy.

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “The approval of IMFINZI in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy. Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.”

The acceptance of IMFINZI is based on the positive PFS data from the Phase III Pacific trial that exhibited remarkable improvement of IMFINZI in median PFS  of 11.2 months compared to placebo, representing a 48% reduction in relative risk of progression or death vs placebo in all patients, regardless of PD-L1 status. The PACIFIC trial is ongoing to assess overall survival in Stage III NSCLC.

IMFINZI can cause profound , fatal adverse reactions. In patients on IMFINZI , common adverse greater than or equal to 20% of patients were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%).

Discontinuation after concurrent CRT due to adverse events, regardless of causality, occurred in 15% of patients receiving IMFINZI vs 10% of patients.

The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every two weeks until disease progression, unacceptable toxicity, or a maximum of 12 months.

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology were updated to include IMFINZI for the treatment of patients with unresectable Stage III NSCLC.