Oncolytics Biotech Inc T.ONC

RE:AstraZeneca's ADC disappoints - on severe adverse events

[Noteable]

May 28, 2024 - Daiichi Sankyo's Enhertu and antibody-drug conjugate (ADC) partner AstraZeneca has failed to prove overall survival (OS) benefit in Phase 3 clinical trial. 

Datopotamab deruxtecan, or Dato-DXd for short, is a TROP2-directed ADC from the same production line that delivered the blockbuster Enhertu. The FDA accepted an application for Dato-Dxd as a treatment for non-squamous non-small cell lung cancer (NSCLC) in February, with a decision not expected until the end of this year. 

Now, the companies have revealed the high level overall survival (OS) results from the same trial, and it doesn’t make for happy reading. When assessed across the overall trial population, the survival results “numerically favored” Dato-DXd “but did not reach statistical significance,” they said. 

While the drugmakers didn’t go into more details about the OS data, they were keen to point out that a “clinically meaningful” improvement in OS against docetaxel was seen when they drilled down into the subgroup of patients with nonsquamous NSCLC. 

The trial’s results still support the ongoing approval applications with U.S. and EU regulators, both companies stressed in the May 27 release. "

https://www.fiercebiotech.com/biotech/astrazeneca-daiichis-enhertu-follow-unable-prove-overall-survival-benefit-phase-3