Gilead Sciences last week announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Sacituzumab Govitecan as monotherapy indicated for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease. The final European Commission decision on the Marketing Authorisation Application for Sacituzumab Govitecan is anticipated later in 2021.
In a statement, the company said that TNBC is the most aggressive type of breast cancer and accounts for approximately 15 per cent of all breast cancers. Sacituzumab Govitecan is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a protein located on the surface of cells and is overexpressed in TNBC and many other tumours.
“Effective treatment options are extremely limited for patients with metastatic TNBC, especially once they progress. We are encouraged by this CHMP-positive opinion for Sacituzumab Govitecan, as we are now one step closer to bring this much-needed treatment option to patients across Europe,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
Parsey further added, “We look forward to the final decision by the EMA and the potential for Sacituzumab Govitecan to become a new standard of care for use as a second-line option.”
According to the statement, the positive opinion is supported by results from the phase-3 Ascent study, where Sacituzumab Govitecan showed a statistically significant and clinically meaningful 57 per cent reduction in the risk of disease worsening or death and improved median progression-free survival (PFS) to 4.8 months from 1.7 months seen with physician’s choice of chemotherapy alone among all randomised patients, which included those with and without brain metastases (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Sacituzumab Govitecan also reduced the risk of death by 49 per cent and improved the median overall survival to 11.8 months vs. 6.9 months with physician’s choice of chemotherapy (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001). The most common grade 3 or higher adverse reactions were neutropenia (49.5 per cent), leukopenia (12 per cent), diarrhoea (10.7 per cent), anemia (10.1 per cent), febrile neutropenia (6.6 per cent), fatigue (5.2 per cent), hypophosphatemia (5.2 per cent), nausea (4.1 per cenr) and vomiting (three per cent). The Sacituzumab Govitecan US Prescribing Information has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhoea.
The statement also informed that Sacituzumab Govitecan (under the trade name Trodelvy) is approved in Australia, Canada, Great Britain, Switzerland and the US in metastatic TNBC, and review is also underway in Singapore and China through Everest Medicines.