Source – Gilead
Gilead Sciences, has received approval from the European Commission (EC) for the use of Trodelvy (sacituzumab govitecan) as a monotherapy in the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. This approval is specifically for patients who have undergone endocrine-based therapy and have also received at least two other systemic therapies in the advanced setting.
The European Commission’s decision to approve Trodelvy comes after a positive recommendation from the Committee for Medicinal Products. The approval is based on data from the Phase III TROPiCS-02 study, which demonstrated that Trodelvy provided a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months compared to single-agent chemotherapy (treatment of physician’s choice; TPC). The median OS was 14.4 months with Trodelvy, as opposed to 11.2 months with TPC (hazard ratio [HR]=0.79; 95% CI: 0.65-0.96; p=0.02). Trodelvy also showed a 34% reduction in the risk of disease progression or death (median PFS: 5.5 versus 4.0 months; HR: 0.66; 95% CI: 0.53-0.83; p=0.0003). Notably, three times as many patients treated with Trodelvy remained progression-free at one year compared to those receiving chemotherapy (21% versus 7%).
“The European approval of sacituzumab govitecan is an important milestone for the European breast cancer community. We now have a new treatment option that has delivered a proven and clinically meaningful survival benefit for women in Europe with pre-treated HR+/HER2- metastatic breast cancer.”
– Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain
“Trodelvy could change the outlook for women with pre-treated HR+/HER2- metastatic breast cancer by replacing the standard-of-care chemotherapy that has been their only option for decades. We look forward to working with European authorities to ensure access for these patients who need new treatment options.”
– Bill Grossman, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Gilead Oncology
The TROPiCS-02 study also revealed significant improvements in various secondary endpoint measures with Trodelvy, including objective response rate and time to deterioration assessed by the Global Health Status/Quality of Life and Fatigue scale per EORTC-QLQ-C30. No statistically significant difference in Time to Deterioration in the Pain Scale was observed.
Regarding safety, Trodelvy’s profile is well-characterized and consistent with previous studies, with no new safety signals detected in this patient population. The most frequent serious adverse reactions (>1%) observed were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), and abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). Importantly, no cases of interstitial lung disease (ILD) were reported among patients treated with Trodelvy in the TROPiCS-02 study. The discontinuation rate due to adverse reactions was 6% for Trodelvy, compared to 4% for patients on single-agent chemotherapy.
“Women living with pre-treated HR+/HER2- metastatic breast cancer are focused on time with their loved ones and do not want to worry about running out of treatment options. We welcome the approval of this needed new option that gives pre-treated HR+/HER2- metastatic patients the potential for a longer life.”
– Eva Schumacher-Wulf, Chief Editor, Mamma Mia! Magazine and Metastatic Breast Cancer Patient
Furthermore, the European Society for Medical Oncology (ESMO) Living Guidelines have been updated to include Trodelvy as a category I, A, magnitude of clinical benefit (MCBS) score 3, for women with HR+/HER2- metastatic breast cancer. Additionally, the National Comprehensive Cancer Network (NCCN) has recommended Trodelvy as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer, according to the Clinical Practice Guidelines in Oncology (NCCN Guidelines). Trodelvy carries a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea, and further Important Safety Information is available.
