Gilead Sciences (GILD) Marks Fifth Approval for Trodelvy in Metastatic Triple-Negative Breast Cancer Under Project Orbis Initiative with Health Canada Authorization

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada has approved Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior therapies, at least one of them for metastatic disease. Canada joins Australia, Great Britain, Switzerland, and the United States among the countries that have approved Trodelvy for use under Project Orbis. Project Orbis is an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) with international regulatory authorities as a global collaborative review program for high impact oncology marketing applications across participating countries.

Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2, a protein located on the surface of cells, is overexpressed in TNBC as well as other solid tumors. Beyond the Project Orbis regulatory approvals, the European Medicines Agency validated a Marketing Authorization Application for Trodelvy in March and regulatory review is also underway in Kazakhstan and Saudi Arabia, as well as Singapore via licensing partner, Everest Medicines.

“Because Trodelvy is the first and only targeted treatment to show benefit in overall survival in 2L metastatic TNBC versus chemotherapy, ensuring that it is accessible to eligible patients is imperative,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We pursued innovative regulatory pathways, such as those made possible by Project Orbis, to help make Trodelvy available to patients as rapidly as possible.”

These approvals were supported by data from the Phase 3 ASCENT study, in which Trodelvy showed a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)) and improved median PFS in patients regardless of brain metastasis to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Trodelvy also improved median overall survival to 11.8 months versus 6.9 months with chemotherapy (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death. In the study of 2L+ TNBC patients, the most frequent Grade ≥3 treatment-related adverse events compared to single-agent chemotherapy were neutropenia (52% versus 34%), diarrhea (11% versus 1%), leukopenia (11% versus 6%) and anemia (9% versus 6%). The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.

About the ASCENT Study

The ASCENT study is a global, open-label, randomized Phase 3 study that enrolled more than 500 patients across 230 study locations. The study evaluated the efficacy and safety of Trodelvy compared with a single-agent chemotherapy of the physician’s choice in patients with unresectable, locally advanced or metastatic TNBC who had received at least two prior systemic treatments. Patients were randomized to receive either Trodelvy or a chemotherapy chosen by the patients’ treating physicians. The primary endpoint was progression-free survival (PFS, as determined by blinded independent central review) in patients without brain metastases. Secondary endpoints included: PFS for full study population or intention-to-treat (ITT) population, overall survival in both the ITT population and in the subgroup without brain metastasis, independently determined objective response rate, duration of response, time to onset of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), quality of life and safety. More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.

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