Evandro de Azambuja, President of the Belgian Society of Medical Oncology (BSMO) for 2023-2026, shared on LinkedIn:
“CHMP recommends sacituzumab govitecan plus pembrolizumab for first-line PD-L1-positive metastatic TNBC
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending sacituzumab govitecan in combination with pembrolizumab for the first-line treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10). The recommendation is based on the phase III ASCENT-04/KEYNOTE-D19 trial and now awaits a final decision from the European Commission.
In ASCENT-04/KEYNOTE-D19, the combination of sacituzumab govitecan and pembrolizumab demonstrated a 35% reduction in the risk of disease progression or death compared with chemotherapy plus pembrolizumab, establishing a clinically meaningful improvement in progression-free survival in the first-line setting. The study also incorporated a patient-centred crossover design, allowing patients initially treated with chemotherapy to receive sacituzumab govitecan after disease progression.
As I mentioned in the press release:
‘People with mTNBC need effective treatment options as early as possible in the course of their disease, particularly when their tumors express PD-L1. This positive opinion is welcome news for our patients and the entire clinical community. Sacituzumab govitecan plus pembrolizumab would build on the recent approval of sacituzumab govitecan monotherapy and help establish a sacituzumab govitecan-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status.’ ”
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