Gilead Sciences gets CHMP positive opinion for Trodelvy in pre-treated HR+/HER2- metastatic breast cancer
Foster City: Gilead Sciences, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Trodelvy (sacituzumab govitecan) as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. The final European Commission decision on the additional indication for Trodelvy is anticipated later in 2023.
"This positive opinion from the Committee confirms the clinical benefit and value of sacituzumab govitecan in pre-treated HR+/HER2- metastatic breast cancer and is a positive step toward bringing this treatment option to patients in Europe," said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. "Too many people living with pre-treated HR+/HER2- metastatic breast cancer are without treatment options after their cancer progresses, and this positive opinion is a significant step forward for patients and their loved ones across Europe."
The CHMP positive opinion is supported by results from the Phase 3 TROPiCS-02 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months versus comparator single-agent chemotherapy (treatment of physician’s choice; TPC) (median OS: 14.4 months vs. 11.2 months; hazard ratio [HR]=0.79; 95% CI: 0.65-0.96; p=0.02). Trodelvy also demonstrated a 34% reduction in risk of disease progression or death (median PFS: 5.5 vs. 4.0 months; HR: 0.66; 95% CI: 0.53-0.83; p=0.0003). Three times as many people treated with Trodelvy were progression-free one year versus those treated with chemotherapy (21% vs. 7%).
“When patients with HR+/HER2- metastatic breast cancer develop resistance to endocrine-based therapies, treatment options are limited,” said Bill Grossman, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Gilead Oncology. “Trodelvy has the potential to change this outlook, and we aim to build on the demonstrated benefits in second-line metastatic triple-negative breast cancer. This positive recommendation from the CHMP marks another important step toward making a difference for patients with pre-treated HR+/HER2- metastatic breast cancer in Europe.”
In the TROPiCS-02 study Trodelvy also significantly improved additional secondary endpoint measures, including objective response rate and time to deterioration (TTD) assessed by the Global Health Status/Quality of Life and Fatigue scale per EORTC-QLQ-C30. No statistically significant difference in TTD in Pain Scale was observed.
The safety profile for Trodelvy is well-characterized and consistent with prior studies, with no new safety signals identified in this patient population.
The ESMO Living Guidelines have been updated to include Trodelvy as a category I, A, magnitude of clinical benefit (MCBS) score 3, for HR+/HER2- metastatic breast cancer patients.i
Trodelvy is also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines).
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