ODAC reviewed IMFINZI for treatment of resectable NSCLC based on AEGEAN Phase III trial results
Shubh Goel, VP and US Franchise Head, Immuno-Oncology and GI Tumors at
“This post is intended for a US audience.
Yesterday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that our IO therapy met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (rNSCLC) based on the AEGEAN Phase III trial results, with an overall tolerable safety profile.
In that trial, our treatment regimen reduced risk of disease recurrence, progression events or death in patients, regardless of whether they’d had surgery or not. For a patient population that is likely to experience recurrence even after surgery and chemo, the potential benefits are significant.
With the promise of more time – without disease progression or recurrence – we’re hoping that we can improve outcomes in settings that have curative intent. Our goal is to transform the patient experience.
We’re encouraged to hear the ODAC’s discussion and the potential of this therapy for the lung cancer community. Every innovative step forward, from the lab to the clinic, is how we demonstrate unwavering commitment to every lung cancer patient at every stage. Learn more about the announcement here.”
Source: Shubh Goel/LinkedIn