FOSTER CITY - Gilead Sciences, Inc. (Nasdaq: GILD) is presenting new data from the Phase 3 ASCENT trial of Trodelvy 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.

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.

About the ASCENT Trial

The Phase 3, international, multi-center, randomized confirmatory trial enrolled more than 500 patients with relapsed/refractory, metastatic triple-negative breast cancer who had received at least two prior therapies for metastatic disease. Patients were randomized to receive either Trodelvy or a chemotherapy chosen by the patients' treating physicians. The primary endpoint of the study was progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response, time to onset of response, and other measures of safety and tolerability.

About Trodelvy

Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated in the U.S. for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Trodelvy binds to the cell-surface protein Trop-2 and delivers the anti-cancer drug SN-38 to kill cancer cells.

Trodelvy received accelerated approval as a treatment for adult patients with mTNBC who have received at least two prior therapies, based on results of 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.

In addition to multiple ongoing studies of Trodelvy in triple-negative breast cancer, Trodelvy is being developed as an investigational treatment for metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical studies involving Trodelvy, and the possibility that Gilead may be unable to initiate and complete future studies involving Trodelvy in the anticipated timelines or at all. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

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