Tuesday, September 17, 2024

This Is Good News For The Daiichi Sankyo & Merck Collabo- In NSCLC (Lung Cancer)... But Is Not Complete -- So... Immaterial.


I'll add this a couple days late, but the analysis from Fierce alone, is worth a read.

Do go read all that the outlet observed, here -- and a bit:

. . .A phase 3 trial of Daiichi Sankyo and Merck & Co.’s HER3-directed antibody-drug conjugate (ADC) has hit its primary endpoint, boosting plans to take a second shot at FDA approval. But two more people died after developing interstitial lung disease (ILD), and the overall survival (OS) data are immature.

The trial compared the ADC patritumab deruxtecan to chemotherapy in people with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC) after the failure of a third-generation EGFR tyrosine kinase inhibitor such as AstraZeneca’s Tagrisso. Daiichi linked its ADC to progression-free survival (PFS) of 5.5 months in an earlier phase 2, only for manufacturing issues to sink a filing for FDA approval.

In the phase 3 trial, PFS was significantly longer in the ADC cohort than in the chemotherapy control arm, causing the study to hit its primary endpoint. Daiichi included OS as a secondary endpoint, but the data were immature at the time of analysis. The study will continue to further assess OS. . . .


Now you know. . . . smiling into the warm night here. . . one day left. . . then off-grid, for a bit. Grin.

नमस्ते

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