Gilead’s Trodelvy Fails to Meet Primary Endpoint in Lung Cancer Trial, but Shows Promise in Subgroup Analysis ###

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1. Trodelvy Fails to Meet Primary Endpoint: Gilead Sciences' Trodelvy failed to extend survival in a phase 3 lung cancer study, missing its primary endpoint of overall survival (OS) compared to chemotherapy docetaxel.
2. Positive Subgroup Analysis: Despite the overall failure, Trodelvy showed a 25% reduction in the risk of death in patients whose tumors did not respond to their last PD-1/L1 treatment, extending median life expectancy by 3.5 months.
3. ASCO Presentation: The results were presented at the American Society of Clinical Oncology (ASCO) annual meeting and published in the Journal of Clinical Oncology.
4. Comparison to Rival Drug: Trodelvy performed better than AstraZeneca and Daiichi Sankyo's Dato-DXd in patients with squamous NSCLC, but the FDA may limit indications based on genomic alterations.
5. Regulatory Update: Gilead will provide a regulatory update on Trodelvy's NSCLC bid when appropriate, with the FDA expected to deliver a verdict on Dato-DXd in December.
6. Broader Lung Cancer Program: Gilead has a broad clinical development program in lung cancer, including ongoing Phase 3 studies and several Phase 2 studies, including the EVOKE-02 study of Trodelvy in combination with pembrolizumab.