Gilead's Trodelvy (Sacituzumab Govitecan) Receives EU Approval for Metastatic Triple-Negative Breast Cancer and Enters Priority Review in China

Gilead Sciences recently announced that the European Commission (EC) has approved the targeted anticancer drugTrodelvy (sacituzumab govitecan, GSK), as a monotherapy,Used for treatmentHave received at least two prior lines of therapy, at least one of which is for unresectable or metastatic triple-negative advanced diseaseBreast Cancer(mTNBC) adult patients.

TNBC is the most aggressive type of breast cancer, accounting for approximately 15% of all breast cancer cases. It is more common in younger and premenopausal women and is more prevalent among Black and Hispanic women. The 5-year survival rate for this subtype is 12%, compared to 28% for other types of breast cancer. These poor prognoses are often accompanied by a significant decline in quality of life, particularly in cases of recurrent or refractory disease.The treatment of metastatic TNBC is particularly challenging. The approval this time includes Trodelvy as a second-line treatment for metastatic TNBC, which is highly significant for the TNBC community and will help extend patients' lives.

Trodelvy is a novel first-in-class antibody-drug conjugate (ADC) targeting Trop-2, a protein located on the cell surface, which is highly expressed in TNBC and many otherTumorOverexpressed in China. To date, Trodelvy has been approved in the United States, Switzerland, the United Kingdom, Australia, and Canada for the treatment of TNBC. Additionally, through licensed partnersEverest MedicinesTrodelvy is also undergoing regulatory review in China and Singapore. Recently,Trodelvy has also been included in the latest ESMO Clinical Practice Guidelines as the preferred treatment option for metastatic TNBC after taxane therapy.

It is worth mentioning that,Trodelvy is the first targeted therapy to outperform standard of care (chemotherapy) in second-line treatment for metastatic TNBC, marking a significant advancement and set to become the new standard of care for second-line metastatic TNBC.. In the Phase 3 ASCENT study, compared with chemotherapy,Trodelvy Significantly Extended Progression-Free Survival(Median PFS: 4.8 months vs 1.7 months, significantly reducing the risk of disease progression or death by 57% (HR=0.43, p<0.0001), regardless of the presence of brain metastases. Additionally, compared with chemotherapy,Trodelvy Significantly Extended Overall Survival(Median OS: 11.8 months vs 6.9 months), significantly reducing the risk of death by 49% (HR=0.51, p<0.0001).

Dr. Merdad Parsey, Chief Medical Officer of Gilead Sciences, stated: "Gilead is committed to delivering transformative science and innovative therapies to address critical unmet medical needs. Treating metastatic TNBC is extremely challenging, with very limited effective options available. We are proud that Trodelvy will now offer a second-line treatment option to extend the lives of patients with this aggressive disease."

Trodelvy Structural Features (Source: broadpharm.com)

Trodelvy is a novel, first-in-class antibody-drug conjugate (ADC) targeting Trop-2, composed of a humanized IgG1 antibody targeting the TROP-2 antigen conjugated with SN-38, the metabolically active product of the chemotherapy drug irinotecan (a topoisomerase I inhibitor), with a drug-to-antibody ratio as high as 7.6:1. Trop-2 is a marker expressed in many epithelial...Tumor(including TNBC) is a cell surface protein frequently expressed in over 90% of TNBC. Trodelvy targets and binds to Trop-2, delivering the anticancer agent SN-38 to kill cancer cells.

Trodelvy, developed by Immunomedics, is based on its proprietary ADC platform, which utilizes a novel linker that does not require enzymes to release the payload, and can function within tumor cells andTumorDelivery of active drugs in the microenvironment, thereby generating a bystander effect. April 2019,Everest MedicinesSigned an agreement with Immunomedics to acquire the rights to Trodelvy in Greater China, South Korea, Mongolia, and Southeast Asian countries and regions. In September 2020, Gilead Sciences acquired Immunomedics for $21 billion, bringing Trodelvy into its portfolio.

In the United States, Trodelvy has been approved for 2 indications: (1) for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least 2 prior therapies, with at least 1 therapy for metastatic disease; (2) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and a PD-1 inhibitor or PD-L1 inhibitor.

In China, Trodelvy (Sacituzumab Govitecan) was included in the 2020 edition of the "Chinese Guidelines for Standardized Diagnosis and Treatment of Advanced Breast Cancer" in October 2020. These guidelines were developed by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Chinese Anti-Cancer Association.TumorJointly compiled by the Professional Committee of Drug Clinical Research.In May 2021, the National Medical Products Administration (NMPA) accepted the biologics license application for Trodelvy and granted it priority review.

Breast cancer is the most common type of cancer among women, with more than 2 million cases diagnosed globally each year. Triple-negative breast cancer (TNBC) accounts for approximately 15% of all breast cancer cases and is more prevalent in women under the age of 50 compared to other types of breast cancer. TNBC refers specifically to breast cancer that tests negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2). It progresses rapidly, has a very poor prognosis, with a 5-year survival rate of less than 15%. TNBC does not respond to hormone therapy or HER2-targeted therapies (such as Roche's Herceptin), leaving very limited clinical treatment options, primarily relying on chemotherapy.

Source of the original text:Trodelvy® (sacituzumab govitecan) Granted European Commission Marketing Authorization for Treatment of Metastatic Triple-Negative Breast Cancer in Second Line