Sacituzumab Govitecan (breast cancer treatment), ok from europe commission

by time news

Gilead Sciences announced that the European Commission (EC) has granted theMarketing Authorization per sacituzumab govitecan, a drug conjugated antibody (parent of its class) directed against the anti-trophoblast 2 surface antigen (Trop-2), as monotherapy indicated for the treatment of adult patients with triple negative breast cancer (TNBC, triple-negative breast cancer) inoperable or metastatic who have received two or more previous systemic therapies, of which at least one for advanced disease.

TNBC: what it is

TNBC is the most aggressive type of breast cancer; it represents about 15% of all breast cancers. TNBC is most commonly diagnosed in younger and premenopausal women, and is more prevalent among Black and Hispanic women. THEThe five-year survival rate for this subtype of breast cancer is 12%, compared with 28% for other types of breast cancer, and these poor outcomes are often associated with a significant decrease in quality of life, especially in relapsed / refractory disease.

“Among breast cancers, the triple-negative subtype is characterized by greater biological and clinical aggression. Furthermore, after the first line of therapy in metastatic disease, chemotherapy is essentially the only weapon available with extremely unsatisfactory results for many patients “, says the Dr. Giampaolo Bianchini, Head of the Mammella Group of the IRCCS San Raffaele Hospital in Milan.

“Sacituzumab govitecan is a newly developed drug which, through an antibody that recognizes a protein specifically expressed by the tumor, brings with it a powerful chemotherapy capable of eliminating tumor cells, reducing the exposure of healthy tissues. The efficacy results of this drug compared with the different chemotherapies available today are extraordinary, having shown a substantial doubling of the survival probabilities of these patients and a seven times higher response rate “. And he concludes: “The hope is that this very important therapeutic option, which has just received approval from the EMA, will be effectively made usable in the shortest possible time even by Italian patients”.

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The research group of Dr. Bianchini has contributed most to the development plan of Sacituzumab govitecan in Italy.

The reasons for the European decision

The EC decision is supported by findings from the phase III ASCENT study, in which sacituzumab govitecan reduced the risk of death by 49% and prolonged median overall survival to 11.8 months, compared to 6.9 months with chemotherapy. physician’s choice (HR: 0.51; 95% CI: 0.41-0.62; p <0.0001). These data also demonstrated a statistically and clinically significant 57% reduction in the risk of death or disease exacerbation and prolonged progression-free survival (PFS, progression free survival) median at 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%), hypophosphataemia (5.2%), nausea (4.1%) and vomiting (3.0%).

Sacituzumab govitecan was recently included in the updated ESMO clinical practice guidelines as a preferred treatment option for metastatic TNBC after taxanes.

The ASCENT clinical study

ASCENT is a phase III, randomized, open-label, global clinical trial that enrolled over 500 patients at 230 sites. The study evaluated the efficacy and safety of sacituzumab govitecan versus a single agent chemotherapy chosen by the treating physician in patients with unresectable, locally advanced or metastatic TNBC who had received at least two previous systemic treatments. Patients were randomized to receive sacituzumab govitecan or a chemotherapy chosen by their treating physicians. The primary endpoint was progression-free survival (PFS, as determined by a blinded independent central review) in patients without brain metastases. Secondary endpoints included: PFS for the complete study population or for the population intention-to-treat (ITT), overall survival (OS, overall survival) in both the ITT population and the subgroup without brain metastases, objective response rate (ORR, objective response rate) independently determined, duration of response (DoR, Duration of Response), time to start of response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1, Response Evaluation Criteria in Solid Tumors), quality of life (QoL, Quality of Life) and safety.

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Triple negative breast cancer (TNBC, triple negative breast cancer)

TNBC is the most aggressive type of breast cancer; it accounts for about 15% of all breast cancers. TNBC is most commonly diagnosed in younger and premenopausal women, and is more prevalent among Black and Hispanic women. TNBC cells have no estrogen and progesterone receptors, and have limited HR2 (human epidermal growth factor receptor 2) expression. Due to the nature of TNBC, treatment options are extremely limited compared to other types of breast cancer. TNBC is more likely to recur and metastasize than other types of breast cancer. The median time to metastatic recurrence for TNBC is approximately 2.6 years, compared with 5 years for other breast cancers, and the related five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

Sacituzumab govitecan

Parent of its class, sacituzumab govitecan is an antibody conjugated to a topoisomerase inhibitor targeting the Trop-2 receptor, a protein overexpressed in several types of epithelial cancers, including metastatic triple negative breast cancer (TNBC) and metastatic urothelial carcinoma. (UC, urothelial cancer), where high expression is associated with poor survival and relapse. Sacituzumab govitecan is approved in second-line metastatic TNBC in several countries around the world, including Australia, Canada, Great Britain, the European Union, Switzerland and the United States. Sacituzumab govitecan is also approved for use in urothelial cancer (UC) in the United States. Sacituzumab govitecan continues to be developed for potential use in other populations with metastatic TNBC and UC, and is also under development as an experimental treatment for hormone receptor positive / epidermal growth factor receptor negative metastatic breast cancer. human 2 (HR + / HER2-) and for metastatic non-small cell lung cancer. Further research is also underway on several solid tumors.

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Gilead Sciences

Gilead Sciences is a California-based biopharmaceutical company that has been researching and developing innovative drugs to contribute to the health of the world for over thirty years. The company is committed to medical progress for the prevention and treatment of diseases such as HIV / AIDS, liver disease, hematology and oncology. Gilead has been based in Milan since 2000 and collaborates with institutional, scientific, academic, industrial partners and local communities to research, develop and make available therapies also for Italian patients.

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