AstraZeneca says FDA approves inclusion of overall survival data on Imfinzi's label in unresectable, Stage III lung cancer

AstraZeneca announced Monday that the FDA approved the inclusion of overall survival (OS) data from the Phase III PACIFIC trial on prescribing information for the PD-L1 inhibitor Imfinzi (durvalumab) in patients with unresectable, Stage III non-small-cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Olivier Nataf, head of US oncology at the company, said the decision continues "to reinforce the PACIFIC regimen as the standard of care in this curative-intent setting."

According to AstraZeneca, the label update was based on results from the primary survival analysis of the study published last year, which demonstrated a significant OS benefit for treatment with Imfinzi versus placebo in this setting, reducing the risk of death by 32%. More recently, a three-year post-hoc OS analysis detailed at the American Society of Clinical Oncology (ASCO) annual meeting showed that results remained consistent with the two-year data, with a 31% reduction in the risk of death compared to placebo.

Imfinzi initially gained US approval for the treatment of unresectable, Stage III NSCLC last year, with the decision based on progression-free survival (PFS) data from the PACIFIC trial. Specifically, results showed that in the study, Imfinzi demonstrated an improvement in median PFS of 11.2 months compared to placebo, representing a 48% reduction in relative risk of progression or death in all patients, regardless of PD-L1 status.

Sales of Imfinzi in the first quarter surged 376% year-over-year to $295 million, fuelled by the launch of the drug for the treatment of unresectable, Stage III NSCLC.

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