Gilead Advances Oncology Portfolio With New Data From Phase 3 ASCENT Trial of Trodelvy® in Metastatic Triple Negative Breast Cancer

IndustryPRwire -- Gilead Sciences is presenting new data from the Phase 3 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 2 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; see below for Important Safety Information.

Based on the overall efficacy and safety results with Trodelvy in the Phase 3 ASCENT trial, Gilead has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for full approval as a treatment for adult patients with mTNBC who have received at least two prior therapies.

“These new data and analyses from the ASCENT trial continue to demonstrate the benefits of Trodelvy in a difficult-to-treat patient population and reinforce the role of Trodelvy as an important treatment option for mTNBC patients,” said Loretta M. Itri, Chief Medical Officer of Immunomedics, a wholly owned subsidiary of Gilead.

“We look forward to working with the FDA in their review of the sBLA submission for Trodelvy in mTNBC, and partnering with the agency, clinical trial investigators and participants as we build on the work of Immunomedics and continue to study Trodelvy in other cancers with unmet medical need,” said Daejin Abidoye, Senior Vice President, Head of Oncology, Gilead Sciences.

Data and analyses from the Phase 3 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)

About Triple-Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer, accounting for up to 20% of all breast cancers. The disease is diagnosed more frequently in younger and premenopausal women and is highly prevalent in African American and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Medicines targeting these receptors therefore are not typically effective in treating TNBC. There is currently no approved standard of care for people with previously treated metastatic TNBC.

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