FDA Grants Durvalumab Breakthrough Therapy Designation for Locally-Advanced Lung Cancer

The FDA granted Breakthrough Therapy Designation to durvalumab (Imfinzi) to treat patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC).

Durvalumab is a human monoclonal antibody designed to block PD-L1 interaction with PD-1 and CD80 on T cells, according to a press release.

The designation was granted based on interim results from the phase 3 PACIFIC trial. It is AstraZeneca’s fourth Breakthrough Therapy Designation for a new oncology medication in 3 years.

PACIFIC was a randomized, double-blind, multicenter, placebo-controlled, clinical trial examining durvalumab as a sequential treatment in patients with locally-advanced, unresectable NSCLC, whose disease did not progress following platinum-based chemotherapy concurrent with radiation therapy.

The ongoing trial is being conducted in 235 centers across 26 countries, including the United States, Canada, Europe, Japan, Korea, Taiwan, South and Central America, Australia, and South Africa.

The primary endpoints of PACIFIC are progression-free survival (PFS) and overall survival (OS), according to the release. Secondary endpoints include landmark PFS and OS, objective response rate, and duration of response.

“For patients who have not progressed following chemoradiation therapy, the only current option is active monitoring,” Sean Bohen, executive vice president of Global Medicines and Development and chief medical officer at AstraZeneca, said in the release. “Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation we hope to bring it to patients as soon as possible.”

Data from the PACIFIC clinical trial has been submitted for presentation at a forthcoming medical meeting, the release noted.

Durvalumab is currently being tested in the adjuvant NSCLC setting in the phase 3 ADJUVANT trial. It is also being examined in a stage 4 first-line NSCLC setting as a monotherapy and in combination with tremelimumab in the phase 3 trials MYSTIC, NEPTUNE, and PEARL.