AstraZeneca Reports Inclusion of Overall Survival Data in Labelling of Imfinzi (durvalumab) in the US

AstraZeneca Reports Inclusion of Overall Survival Data in Labelling of Imfinzi (durvalumab) in the US

Shots:

  • The US FDA has approved the inclusion of OS data based on P-III PACIFIC study results in an update to the Imfinzi (durvalumab) US prescribing information for patients with unresectable, Stage III NSCLC prior not treated with platinum-based CT and radiation therapy (CRT)
  • The P-III study results demonstrated OS benefit by reducing the risk of death by 32% following 3yrs. post-hoc OS analysis showing 31% reduction in risk of death and 57% are still alive patients vs 44% with PBO
  • Imfinzi is a mAb targeting PD-L1, blocking its interaction with PD-1 and CD80 to counter the tumor’s immune-evading tactics and is an approved therapy in 45+ countries including the US, EU and Japan

Click here to read full press release/ article | Ref: AstraZeneca | Image: Boulder Daily Camera