Barcelona, 22 april 2021
Treatment with sacituzumab govitecan significantly prolongs overall survival in patients with triple-negative metastatic breast cancer, as confirmed by the international trial, ASCENT, published today in the New England Journal of Medicine (NEJM). Dr. Javier Cortés Castán, director of the International Breast Cancer Center (IBCC), has been one of the international leaders of this study, participating in its design and execution.
Triple-negative breast cancer accounts for around 15% of all diagnosed breast tumours and is characterized by the absence of expression of hormone receptors and the lack of expression of the HER2 protein. They are tumours which are associated with a high level of aggressiveness, and have the worst prognosis of all breast tumours, with limited survival when they are in a metastatic stage. Therefore, it is essential to find new and innovative treatments that can improve the prognosis of these patients.
Sacituzumab govitecan is a humanized antibody directed against the TROP2 protein which is linked with the active metabolite of irinotecan (SN-38), a potent chemotherapy that inhibits topoisomerase and prevents the growth of tumour cells. In the words of Dr. Cortés, “it works like a Trojan horse which, when introduced into tumour cells, releases toxic molecules and destroys the tumour”.
Treatment with sacituzumab govitecan improves progression-free survival and overall survival compared to investigator-choice therapy in patients with triple-negative advanced breast cancer who have received at least two chemotherapy regimens for advanced disease, as shown in the ASCENT clinical trial published in NEJM. The primary endpoint of the study was progression-free survival in patients without brain metastases by independent review.
This phase III clinical trial has been conducted in 88 centres in 7 countries and involved 529 patients with triple-negative metastatic breast cancer who had received at least two chemotherapy regimens for advanced disease. These patients were randomized (1:1) to receive sacituzumab govitecan or the investigator’s treatment of choice. The study confirmed that treatment with sacituzumab govitecan significantly increased both progression-free survival, with a 59% reduction in risk of progression or death, and overall survival, with a 52% reduction in risk of death, compared to the investigator’s treatment of choice.
The results of this study establish sacituzumab govitecan as one of the treatments of choice for patients with previously treated triple-negative metastatic breast cancer. At the present time, this treatment is already approved in the United States by the FDA for patients with advanced breast cancer who have received two or more previous systemic therapies, at least one of them for metastatic disease, and its approval is being reviewed as a priority in Europe by the European Medicines Agency (EMA).
”This is the first drug that has managed to improve the survival of patients with triple-negative breast tumours in recent years,” concludes Dr. Cortés