The late-stage trial evaluated the Trop-2 directed antibody-drug conjugate in comparison to TPC chemotherapy in 543 patients having a type of breast cancer
Trodelvy delivers positive OS results in TROPiCS-02 trial. (Credit: mwooten from Pixabay)
Gilead Sciences has reported positive overall survival (OS) results from the TROPiCS-02 phase 3 clinical trial of Trodelvy (sacituzumab govitecan-hziy) in patients having HR+/HER2- metastatic breast cancer.
The late-stage trial assessed the Trop-2 directed antibody-drug conjugate in comparison to TPC chemotherapy.
OS was a key secondary endpoint in the TROPiCS-02 trial, which was conducted on 543 patients with with HR+/HER2- metastatic breast cancer who were subjected to endocrine-based therapies and had at least two chemotherapies.
Compared to TPC, Trodelvy showed a statistically significant and clinically meaningful improvement of 3.2 months in OS.
Earlier this year, TROPiCS-02 study met its primary endpoint, which was progression-free survival.
Trodelvy scored over TPC when it came to other key secondary endpoints of the late-stage study as well, which included objective response rate (ORR).
The drug is not yet approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer. However, it is already approved in several countries for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adult patients.
Based on the findings of the TROPiCS-02 trial, Gilead Sciences has filed a supplemental biologics license application (sBLA) with the US Food and Drug Administration (FDA) for the intended indication.
Gilead Sciences oncology head Bill Grossman said: “With 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 – two difficult-to-treat forms of breast cancer.
“Our Gilead Oncology ambition is to transform care for people with cancer, and the meaningful improvement in survival benefit seen in the TROPiCS-02 study with Trodelvy is another step forward in pursuing this ambition for patients.”