AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi (durvalumab) during the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Toronto, Canada. Results were published simultaneously in the New England Journal of Medicine.
Results from the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following chemoradiation showed that Imfinzi significantly improved OS, the second primary endpoint of the trial, compared to placebo regardless of PD-L1 expression, reducing the risk of death by 32%.
Read the full corporate press release here.
Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.
Read the full FDA announcement here.
On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).
This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC.
Read FDA announcement.