Phase III ASCENT study of Trodelvy met its primary endpoint of progression-free survival for triple negative breast cancer.- Immunomedics Inc.

Immunomedics, Inc. announced that the confirmatory Phase III ASCENT study of Trodelvy (sacituzumab govitecan-hziy) met its primary endpoint of progression-free survival (PFS) , as well as key secondary endpoints in brain metastasis negative patients with mTNBC who have previously received at least two prior therapies for metastatic disease.

In the ASCENT study Trodelvy demonstrated a statistically significant improvement in the primary endpoint of PFS compared to chemotherapy, with a hazard ratio of 0.41 (95% confidence interval (CI), 0.32-0.52).The median PFS for patients treated with Trodelvy was 5.6 months (95% CI, 4.3-6.3), compared to 1.7 months (95% CI, 1.5-2.6) for chemotherapy (p<0.0001). Trodelvy also met key secondary endpoints of the study, including overall survival and objective response rate.

The safety profile of Trodelvy observed in the ASCENT study remained consistent with the FDA -approved label, with neutropenia and diarrhea as the most common Grade 3 or 4 adverse events and no new safety signals were observed. Full results will be presented at an upcoming medical conference.

Trodelvy was recently approved by the FDA as a third-line treatment for adult patients with mTNBC under the agency’s Accelerated Approval Program based on the objective response rate and duration of response observed in a single-arm, multicenter Phase II study. The Phase III confirmatory ASCENT study was designed under an FDA Special Protocol Assessment (SPA) to validate the promising safety and efficacy activity of Trodelvy that supported its accelerated approval ..