AstraZeneca and Daiichi Sankyo’s Dato-DXd Fails to Meet Overall Survival Goal in NSCLC Study, FDA Decision Looms

Clinical Trial Outcome:
The TROPION-Lung01 Phase III trial evaluating Dato-DXd in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) failed to show a statistically significant improvement in overall survival (OS) compared to the standard chemotherapy docetaxel.

Subgroup Analysis:
In the subgroup of patients with non-squamous NSCLC, Dato-DXd demonstrated a clinically meaningful improvement in OS, with a 2.3-month benefit (14.6 months vs. 12.3 months).

Regulatory Status:
AstraZeneca and Daiichi Sankyo have filed a biologics license application (BLA) with the FDA seeking approval for Dato-DXd in non-squamous NSCLC, with a decision expected in the fourth quarter of 2024.

Safety Profile:
Dato-DXd showed a favorable safety profile in the TROPION-Lung01 study, consistent with previous studies, and no new safety concerns were identified.

Analyst Perspective:
Despite the disappointing OS results, analysts like Jefferies' Stephen Barker believe that the likelihood of FDA approval remains high, though the regulator may convene an advisory committee before making a decision.

Ongoing Trials:
AstraZeneca and Daiichi Sankyo are evaluating Dato-DXd in earlier lines of NSCLC treatment and in combination with other therapies, such as Imfinzi (durvalumab), in ongoing clinical trials.