US FDA approves durvalumab for unresectable stage III NSCLC

19 Feb 2018

The US Food and Drug Administration (FDA) has approved durvalumab for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

The approval of ‚Äčdurvalumab is based on the positive PFS data from the Phase III PACIFIC trial in which it demonstrated an improvement 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.

Durvalumab was granted breakthrough designation last year based on interim results.

The PACIFIC trial is ongoing to evaluate overall survival (OS) in unresectable Stage III NSCLC.

Detailed interim results of the PACIFIC trial were published online in the New England Journal of Medicine.

Overall, the incidence and severity of adverse events were comparable for patients receiving durvalumab and the patients receiving placebo.

In patients receiving Imfinzi, the most common adverse reactions (greater than or equal to 20% of patients) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnoea (25%), and rash (23%).

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

Scott J. Antonia, MD, Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and investigator in the PACIFIC trial, said “Until now, treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression. The PACIFIC trial data supporting today’s approval of Imfinzi will change how we treat these patients.”

Source: AstraZeneca