RE:RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventsMay 28, 2024 - Daiichi Sankyo and antibody-drug conjugate (ADC) partner AstraZeneca unable to show OS with ADC Enhertu follow-on in lung cancer.
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. An approval application in HR-positive, HER2-negative breast cancer has also been submitted to the FDA."
The lung cancer submission is based on data from the phase 3 lung cancer trial, which showed that median progression-free survival (PFS)—one of the study’s primary endpoints—was 5.6 months in patients treated with Dato-DXd versus 3.7 months among those treated with the chemotherapy docetaxel.
The trial also assessed Dato-DXd in patients with squamous NSCLC, but it didn’t demonstrate a PFS benefit in this group, resulting in the more limited non-squamous application that the FDA accepted.
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.
https://www.fiercebiotech.com/biotech/astrazeneca-daiichis-enhertu-follow-unable-prove-overall-survival-benefit-phase-3
https://www.astrazeneca-us.com/media/press-releases/2024/datopotamab-deruxtecan-showed-clinically-meaningful-overall-survival-improvement-vs-chemotherapy-in-patients-with-advanced-nonsquamous-non-small-cell-lung-cancer-in-tropion-lung01-phase-iii-trial.html