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US FDA accepts sBLA for Imfinzi in locally advanced and unresectable NSCLC

Published 18 October 2017

AstraZeneca and MedImmune announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

The FDA has granted Imfinzi priority review status.

The US FDA sBLA submission acceptance is an important milestone for IMFINZI in a disease state where patients need better treatment options and outcomes. Currently, the standard of care for these patients with locally advanced (Stage III) lung cancer is active monitoring following definitive chemoradiation.

The sBLA submission is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial. The trial continues to evaluate overall survival (OS), its other primary endpoint.

Detailed results of the PACIFIC trial, including additional safety information, were published online in the New England Journal of Medicine.

On September 28, 2017, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) were updated to include durvalumab for the treatment of patients with locally advanced, unresectable NSCLC with no disease progression after two or more cycles of definitive chemoradiation, based on the data from the PACIFIC Phase III trial. This indication is not yet FDA-approved.

IMFINZI has already received accelerated approval in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

The PACIFIC trial is a randomized, double-blind, placebo-controlled, multi-center trial of durvalumab as sequential treatment in unselected patients with locally advanced, unresectable (Stage III) non-small cell lung cancer who have not progressed following platinum-based chemotherapy concurrent with radiation therapy.

The trial involved 235 centers across 26 countries, including approximately 700 patients. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS), and secondary endpoints include landmark PFS and OS, objective response rate, duration of response and time to death or distant metastases.

IMFINZI® (durvalumab) is a human monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1 and CD80.

IMFINZI has already received accelerated approval in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

As part of a broad development program, durvalumab is also being investigated for the adjuvant treatment of patients with NSCLC in the CCTG (Canadian Cancer Trials Group) trial ADJUVANT (BR31). In the MYSTIC, NEPTUNE, and PEARL Phase III trials, durvalumab is being studied for 1st-line treatment as monotherapy and/or in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody, for the treatment of metastatic NSCLC.

The POSEIDON trial is investigating durvalumab with and without tremelimumab in combination with chemotherapy in the same population.



Source: Company Press Release