Javier Cortés, physician and first author of the same and director of the International Breast Cancer Center (IBCC).
And study conducted by researchers from International Breast Cancer Center (IBCC) have shown that adding a type of immunotherapy, pembrolizumabwing chemotherapy frontline, improves a 27% overall survival patients with advanced triple-negative breast cancer with expression of PD-L1. The study, published in the scientific journal The New England Journal of Medicine (NEJM), opens the door to a new standard of care in this patient population. It is therapeutic breakthrough the most important of last ten years in the triple negative breast cancer breakthrough in the field of immunotherapy.
The study, conducted by Javier CortesDirector of IBCC, and Jose Manuel Perez Garciadeputy director of the IBCC, presented at the congress of the American Society for Clinical Oncology of 2020 (ASCO) the first results of the study. The findings were so relevant that in November 2020, the regulatory agency Food and drug administration (FDA) approved in the United States the treatment with pembrolizumab in combination with chemotherapy, whereas, after the presentation of more mature data overall survival in the European Society of Medical Oncology (ESMO), it was decided to approve the same indication by the European Medicines Agency (EMA) in October 2021.
Javier Cortés, first author of the work, underlines the following: “Until now, we had not reached improve overall survival in advanced triple-negative breast cancer with a immunotherapy-based treatmentas we did with pembrolizumab. We knew of other pathologies such as melanoma there lung cancer, but we have never been able to demonstrate this in this subtype of breast cancer. This is very relevant news because triple negative breast cancer is currently the worse prognosis and one of the subtypes that oncologists are most interested in finding new therapies which improve the survival and quality of life of our patients”.
The phase III, randomized, double-blind study was carried out in 209 centers from 29 countries and included a total of 847 patients with triple negative breast cancer whether or not they express the PD-L1 biomarker. These patients had received no prior therapy for metastatic disease. Patients were randomized to receive treatment with chemotherapy and pembrolizumab oh chemotherapy plus placebo, so 566 patients received chemotherapy and pembrolizumab and 281 received chemotherapy plus placebo. The two primary endpoints of the study were progression-free survival (PFS) and overall survival in patients with different PD-L1 expression and in the intent-to-treat population.
Median survival with immunotherapy is 23 months
After a follow-up 44.1 monthsthe Keynote-355 study also showed that adding pembrolizumab to chemotherapy treatment increases statistically significantly by almost 7 months overall survival in patients with advanced triple-negative breast cancer with PD-L1 expression. The median the overall survival of patients who received chemotherapy and pembrolizumab was 23 months and 16.1 months in the group that received chemotherapy plus placebo.
The authors conclude that, in patients with advanced triple-negative breast cancer whose tumors express the biomarker PD-L1, “the addition of pembrolizumab to chemotherapy results in significantly longer overall survival than chemotherapy alone.
“This drug has shown a benefit to In tumors that have a biomarker, the PD-L1. And that’s good news, because we can know which patients are going benefit to of this immunotherapybefore to manage. About 40% of patients with triple negative breast cancer have high levels of this biomarker”, explains Javier Cortés.
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