Gilead fails outside triple negative

Gilead’s effort to broaden Trodelvy’s reach has hit another obstacle. The Ascent-07 study failed to meet its primary endpoint of progression-free survival in patients with ER-positive, HER2-negative breast cancer who had progressed after endocrine therapy. In the study, the TROP2-targeting ADC was tested head-to-head against chemotherapy. The topline miss does not give a lot of hope, but the company tried to give some, noting a “positive trend” in the key secondary endpoint of overall survival favouring Trodelvy. However, Gilead withheld specifics on the maturity of the OS data, leaving open questions about the magnitude and relevance of the benefit. The company also emphasised that these results do not affect Trodelvy’s existing approval in late-line ER-positive, HER2-negative breast cancer, which was based on the Tropics-02 trial in patients previously treated with endocrine therapy and at least two additional drugs. But this latest setback narrows the potential market for Trodelvy, which is driven mainly by its use in triple-negative breast cancer. In contrast, AstraZeneca and Daiichi’s Datroway has been delivering more consistent data across several solid tumours, potentially positioning it to seize a larger share of the TROP2 space.

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Source: OncologyPipeline.