The European Commission authorizes the marketing of sacituzumab govitecan to treat second-line metastatic triple negative breast cancer


Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the European Commission (EC) has granted marketing authorization to sacituzumab govitecan (under the trade name Trodelvy), an antibody-drug conjugate targeting Trop-2 and the first of its class, as monotherapy indicated for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNTC) who have received two or more previous systemic treatments, at least one of them for advanced disease.

“The metastatic stage of CMTN is especially difficult to treat and we urgently needed new treatment options for people with this disease in Europe,” said Dr. Véronique Diéras, lead medical oncologist in the Breast Cancer Group of the Department of Medical Oncology at the Eugène Marquis Center in Rennes (France). “Today’s approval, which includes second-line metastatic CMTN, is significant for the entire medical community as it is an important step in helping women with this disease live longer,” he concluded.

CMTN is the most aggressive type of breast cancer, accounting for approximately 15% of all breast cancers. It is most often diagnosed in young and premenopausal women and is more common in black and Hispanic women. The 5-year survival rate for this subtype of breast cancer is 12%, compared to 28% for other types of breast cancer, and these poor results are often accompanied by a significant decrease in quality of life. especially in relapsed / refractory disease.

“At Gilead, we are trying to push our limits to deliver transformative science and novel treatment options that address urgent medical needs,” said Merdad Parsey, MD, PhD, Gilead Sciences Chief Medical Officer. “We understand how difficult it is to treat metastatic CMTN and we are proud that Trodelvy can now offer a second-line treatment option with the potential to extend the lives of people living with this aggressive disease,” he noted.

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The European Commission’s decision is supported by the results of the phase 3 Ascent study, which shows that the molecule reduced the risk of death by 49% and improved the median overall survival to 11.8 months versus 6, 9 months with chemotherapy chosen by the doctor (HR: 0.51; 95% CI: 0.41-0.62; p <0.0001). These data also showed a statistically significant and clinically significant 57% reduction in risk of death or disease worsening and an improvement in median progression-free survival (PFS) to 4.8 months from 1.7 months observed with physician-chosen chemotherapy alone among all randomized patients, which included those with and without brain metastases (HR: 0.43; 95% CI: 0.35-0.54; p <0.0001).

The most common grade 3 or higher adverse reactions were neutropenia (49.5%), leukopenia (12.0%), diarrhea (10.7%), anemia (10.1%), febrile neutropenia (6.6%) ), fatigue (5.2%), hypophosphatemia (5.2%), nausea (4.1%) and vomiting (3.0%) 7.

In addition to this authorization for the European market, the treatment is approved in Australia, Canada, Great Britain, Switzerland and the United States for the treatment of CMTN. A regulatory review is also underway in Singapore and China with applications submitted by Everest Medicines. Furthermore, this drug has recently been included in the updated ESMO Clinical Practice Guidelines as a preferred treatment option for metastatic CMTN after taxanes.

The Ascent study is a global, open-label, randomized phase 3 study involving more than 500 patients at 230 study centers. The study evaluated the efficacy and safety of sacituzumab govitecan compared to a physician-chosen single agent chemotherapy in patients with unresectable, locally advanced, or metastatic NTMC who had received at least two prior systemic treatments. The patients were randomized to receive this treatment or a chemotherapy chosen by the treating physicians.

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The primary endpoint was progression-free survival (PFS, determined by an independent, blinded, centralized review committee) in patients without brain metastases. The secondary endpoints were: PFS for the entire study population or the intention-to-treat (ITT) population, overall survival (OS) in both the ITT population and the subgroup without brain metastases, the objective response rate (ORR) independently determined, duration of response (DoR), time to onset of response according to the Evaluation Criteria for Response in Solid Tumors (RECIST 1.1), quality of life (QoL) and security.

Metastatic triple negative breast cancer (mNMSC) is the most aggressive type of breast cancer, accounting for approximately 10-15% of all breast cancers. CMTN is most often diagnosed in young and premenopausal women and is more common in black and Hispanic women. CMTN cells do not express estrogen and progesterone receptors and express limited HER2.