AstraZeneca and Gilead Explore TROP2 ADCs in Lung Cancer, Seeking Pathways to Approval

TROP2 ADCs in Lung Cancer:
AstraZeneca and Gilead are focusing on TROP2-directed antibody-drug conjugates (ADCs) for treating non-small cell lung cancer (NSCLC), with mixed results in recent trials.

Datopotamab Deruxtecan (Dato-DXd):
AstraZeneca's Dato-DXd showed a 25% reduction in the risk of disease progression or death in NSCLC patients, particularly in those with non-squamous tumors, but overall survival results did not reach statistical significance.

Trodelvy:
Gilead's Trodelvy, another TROP2 ADC, failed to meet the primary endpoint of overall survival in a Phase III study but showed a 16% reduction in the risk of death in a subgroup of patients who had failed on chemotherapy and PD-1/L1 therapy.

Subgroup Analysis:
Both Dato-DXd and Trodelvy showed more promising results in specific subgroups, such as patients with actionable genomic alterations (AGAs) and those who did not respond to immunotherapy.

Future Directions:
Despite the challenges, both companies are exploring further research and potential regulatory pathways, with AstraZeneca focusing on a subgroup of lung cancer patients and Gilead planning to continue researching Trodelvy's effectiveness in specific patient populations.

Regulatory Status:
The FDA is expected to deliver a verdict on Dato-DXd's NSCLC application in December, while Gilead will provide a regulatory update on Trodelvy's NSCLC bid when appropriate.

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