Gilead Trodelvy shows 3.2-month benefit for new breast cancer indication
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Gilead Sciences (NASDAQ:GILD) announced that its antibody-drug conjugate Trodelvy indicated a statistically significant and clinically meaningful improvement of 3.2 months in overall survival (OS) versus chemotherapy in certain patients with HR+/HER2- metastatic breast cancer.
The results were based on the 543-patient Phase 3 TROPiCS-02 trial in which patients received Trodelvy or physiciansâ choice of chemotherapy. The trial subjects were previously treated with endocrine-based therapies and at least two chemotherapies for metastatic disease.
In terms of OS, a key secondary endpoint of the trial, the Trodelvy arm indicated a median OS of 14.4 months compared to 11.2 months in the comparator arm leading to 3.2 months of benefit versus the physiciansâ choice of chemotherapy, TPC.
The trial also indicated a statistically significant improvement favoring Trodelvy versus TPC for objective response rate (ORR), another key secondary endpoint.
The safety profile of Trodelvy in TROPiCS-02 was consistent with prior studies for the drug, GILD said, adding that there were no new safety signals.
âWith these data from TROPiCS-02, Trodelvy has now demonstrated a survival benefit in both pre-treated HR+/HER2- metastatic breast cancer and second-line metastatic TNBC â two difficult-to-treat forms of breast cancer,â noted Bill Grossman, GILDâs Therapeutic Area Head.
In March, GILD said TROPiCS-02 met the primary endpoint of progression-free survival with statistical significance.