Gilead advances new data from phase III ASCENT trial of Trodelvy in metastatic triple negative breast cancer.

Gilead Sciences, Inc.is presenting new data from the Phase III ASCENT trial of Trodelvy (sacituzumab govitecan-hziy) in metastatic triple-negative breast cancer (mTNBC) at the 2020 San Antonio Breast Cancer Symposium being held virtually December 8-11, 2020. The new data and analyses from the ASCENT trial continue to demonstrate the high clinical activity of Trodelvy in this patient population with traditionally poor outcomes.Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate that is indicated in the U.S. for the treatment of adult patients with mTNBC who have received at least two prior therapies for metastatic disease. Trodelvy received accelerated approval for this patient population in April 2020, based on objective response rate and duration of response results observed in a single-arm, multicenter Phase II study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe neutropenia and severe diarrhea. Data and analyses from the Phase III ASCENT trial being presented at SABCS 2020 include : An exploratory analysis demonstrating overall survival, objective response rate and progression-free survival with Trodelvy versus chemotherapy in brain metastases-negative mTNBC patients irrespective of Trop-2 expression levels. Trop-2 receptors are expressed on the surface of many epithelial tumor cells and linked to poor prognosis, including decreased survival. (Abstract #GS3-06). An exploratory analysis demonstrating tumor response, progression-free survival and overall survival with Trodelvy versus chemotherapy in a subset of mTNBC patients with stable brain metastases of limited sample size (Trodelvy, N=32; TPC, N=29). (Abstract #PD13-07). Additional safety data on Trodelvy in mTNBC patients with reduced uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) activity. Patients who are homozygous for the UGT1A1 28 allele are at increased risk for neutropenia following initiation of treatment with Trodelvy. (Abstract #PS11-09). Based on the overall efficacy and safety results with Trodelvy in the Phase III ASCENT trial, Gilead has submitted a supplemental Biologics License Application (sBLA) to the FDA for full approval as a treatment for adult patients with mTNBC who have received at least two prior therapies.