#None #Sacituzumab #TNBC #Pembrolizumab

Major Breakthrough in Breast Cancer Treatment

The European Commission has recently approved an innovative combination therapy involving sacituzumab govitecan and pembrolizumab for the primary treatment of metastatic and recurrent triple-negative breast cancer (TNBC). This new therapy is now available regardless of PD-L1 expression, representing a substantial leap forward in cancer treatment options. As a result, sacituzumab govitecan becomes the first and only antibody-drug conjugate that can be utilized in the primary treatment of TNBC, irrespective of PD-L1 presence.

On August 24, Gilead Sciences made the announcement regarding this significant approval, which will benefit adult patients suffering from locally advanced or metastatic TNBC that are unable to undergo surgery and have no history of systemic therapy for advanced breast cancer. This combination therapy can hopefully pave the way for more effective treatment of one of the most aggressive forms of breast cancer.

The approval allows sacituzumab govitecan and pembrolizumab to be delivered as a combination therapy in the 27 member states of the European Union, as well as Norway, Iceland, and Liechtenstein. It addresses the urgent need for more effective treatment options for metastatic and recurrent TNBC patients, who historically have limited choices.

This decision follows the recent approval of sacituzumab govitecan as monotherapy for patients with locally unresectable and metastatic or recurrent TNBC. It is based on evidence that this therapy provides a foundation for PMD-L1 expression status, offering a lifeline to patients who previously faced dire prognoses. According to Dr. Evandro de Azambuja, Medical Director of the Jules Bordet Institute and ASCENT-04 study principal investigator, this approval is a crucial step for patients diagnosed with PD-L1 positive metastatic TNBC, potentially reshaping standard treatment methodologies.

Data from the Phase III ASCENT-04/KEYNOTE-D19 trial substantiate this therapy’s benefits, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to standard chemotherapy combined with pembrolizumab. Results indicated a 35% reduction in the risk of disease progression or death among patients treated with the combination versus chemotherapy.

Mika Kakefuda Derynck, Senior Vice President of Oncology Clinical Development at Gilead, emphasized that this approval introduces new potential for first-line treatment in TNBC patients within the EU. The groundwork has now been laid to enhance treatment protocol for this aggressive cancer, offering new hope to many.

TNBC accounts for around 15% of all breast cancer cases, typically diagnosed in younger, premenopausal women. It is more prevalent among Black and Hispanic women and is characterized by the absence of estrogen receptors, progesterone receptors, and limited HER2 expression. Unfortunately, TNBC patients struggle with higher recurrence and metastasis rates than those with other breast cancer types. They experience an average metastasis period of only 2.6 years compared to 5 years for other types, with a much lower five-year survival rate of just 12%.

Sacituzumab govitecan is a first-in-class antibody-drug conjugate designed to target TROP-2, known to be highly expressed in over 90% of breast cancer cases. Its complex formulation enables the simultaneous delivery of a topoisomerase I inhibitor, SN-38, to tumor cells. This unique mechanism provides a powerful therapeutic effect in treating TNBC and further expands its potential application across various cancer types in ongoing Phase III trials.

With the increasing necessity for robust therapeutic options in managing TNBC and the successful history of sacituzumab administration in over 75,000 patients globally since 2020, this new approval marks a pivotal moment in oncology, potentially transforming patient outcomes for those battling this formidable cancer.