AZ’s Imfinzi scores FDA breakthrough therapy designation in wake of major trial failure

AstraZeneca’s board explained that the decision was based on promising interim results from the Pacific trial, a Phase 3 investigation where Infimzi was tested as a sequential treatment against NSCLC in the aforementioned indication.  

"For patients who have not progressed following chemoradiation therapy the only current option is active monitoring," said AstraZeneca Chief Medical Officer and Executive Vice President of Global Medicines Development Sean Bohen, in reaction to the announcement. "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."

This designation marks the second of its kind for Imfinzi and the fourth for the company in three years for its new oncology products. The drug has also been awarded accelerated approval in the advanced bladder cancer sphere and is currently being evaluated in the adjuvant NSCLC space.