AstraZeneca (LSE:AZN) said it did not secure majority ODAC support for camizestrant plus a CDK4/6 inhibitor for patients with emergent ESR1 mutations based on data from the SERENA‑6 Phase III trial.
The vote follows the FDA's July acceptance of an NDA and a Breakthrough Therapy Designation granted in May after SERENA‑6 reported a 56% reduction in risk of progression or death (HR 0.44; 95% CI 0.31-0.60; p<0.00001) and median PFS of 16.0 months versus 9.2 months for the comparator AI plus CDK4/6 inhibitor arm.
“We strongly believe in the results of the SERENA‑6 trial, and are encouraged that the Committee saw camizestrant as a safe and effective potential new medicine,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca.
AstraZeneca noted no new safety signals in SERENA‑6 and that discontinuations were very low and similar between arms.
SERENA‑6 is the first global, double‑blind registrational Phase III trial to use ctDNA monitoring to detect emerging endocrine resistance via ESR1 mutations and switch therapy before radiographic progression.
The FDA is not bound by ODAC and AstraZeneca said it will continue to work with the agency while regulatory applications for camizestrant remain under review in the EU, Japan and other countries.
The trial will continue to follow overall survival as a key secondary endpoint.
