Αρχική World News Sacituzumab Govitecan Prolongs Survival in Relapsed or Refractory Metastatic Triple Negative Breast...

Sacituzumab Govitecan Prolongs Survival in Relapsed or Refractory Metastatic Triple Negative Breast Cancer

Sacituzumab govitecan, a first-in-class, Trop-2–directed antibody–drug conjugate, showed in the ASCENT study a significant benefit among patients with relapsed or refractory metastatic triple negative breast cancer (TNBC) in terms of progression-free survival (PFS) and overall survival (OS) as compared with standard of care chemotherapy. Side effects, in particular myelosuppression and diarrhoea, were more frequent with sacituzumab govitecan than with chemotherapy. Dr. Aditya Bardia of the Massachusetts General Hospital Cancer Center in Boston, MA, US and the ASCENT investigators published the primary study results on 22 April 2021 in The New England Journal of Medicine

The authors wrote in the background that patients with metastatic TNBC have poor survival outcomes. Although immunotherapy has shown promising first-line clinical activity, single-agent chemotherapy remains standard for previously treated (beyond first-line) patients with metastatic TNBC. However, chemotherapy is associated with low response rates and short PFS. 

Sacituzumab govitecan is an antibody–drug conjugate composed of antibody targeting Trop-2, coupled to SN-38, the active metabolite of irinotecan and a topoisomerase I inhibitor, through a proprietary hydrolyzable linker. After administration, the anti–Trop-2 monoclonal antibody binds to Trop-2 expressed on the tumour-cell surface and allows for targeted delivery of SN-38 to tumour cells.  

The IMMU-132-01, a phase I/II single group, basket study evaluated sacituzumab govitecan as monotherapy in metastatic, epithelial cancers. In the cohort of 108 patients with metastatic TNBC, an objective response rate of 33%, a median PFS of 5.5 months, and a median OS of 13.0 months was observed with sacituzumab govitecan. These results provided the basis for accelerated approval by the US Food and Drug Administration (FDA) in April 2020, with full approval contingent on the results of the confirmatory phase III study.  

The confirmatory phase III ASCENT is a global, open-label, randomised study that evaluated the efficacy and safety of sacituzumab govitecan as compared with chemotherapy of the physician’s choice (eribulin, vinorelbine, capecitabine, or gemcitabine) in patients with relapsed or refractory metastatic TNBC. The primary endpoint was PFS as determined by blinded independent central review among patients without brain metastases. 

In total, 468 patients without brain metastases were included and randomly assigned to receive sacituzumab govitecan (235 patients) or chemotherapy (233 patients). The median age was 54 years; all the patients were previously treated with taxanes. 

The median PFS was 5.6 months (95% confidence interval [CI] 4.3 to 6.3) with sacituzumab govitecan and 1.7 months (95% CI 1.5 to 2.6) with chemotherapy (hazard ratio [HR] for disease progression or death 0.41; 95% CI 0.32 to 0.52; p < 0.001). 

The median OS was 12.1 months (95% CI 10.7 to 14.0) with sacituzumab govitecan and 6.7 months (95% CI 5.8 to 7.7) with chemotherapy (HR for death 0.48; 95% CI 0.38 to 0.59; p < 0.001). 

The percentage of patients with an objective response was 35% with sacituzumab govitecan and 5% with chemotherapy. 

The incidences of key treatment-related adverse events of grade 3 or higher were neutropenia (51% with sacituzumab govitecan and 33% with chemotherapy), leukopenia (10% and 5%), diarrhoea (10% and <1%), anaemia (8% and 5%), and febrile neutropenia (6% and 2%). There were three deaths owing to adverse events in each group; no deaths were considered to be related to sacituzumab govitecan treatment. 

Based on results from the ASCENT study, the FDA granted regular approval on 7 April 2021 to sacituzumab govitecan for patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.  

Multiple studies of sacituzumab govitecan in patients with breast cancer are ongoing, including evaluation in neoadjuvant treatment of early TNBC (NeoSTAR), adjuvant treatment (GBG102-SASCIA), in the metastatic context in combination with immunotherapy-based regimens (Morpheus-TNBC and Saci-IO TNBC) or with a PARP inhibitor (NCT04039230) in advanced TNBC, and in hormone receptor positive and HER2-negative metastatic breast cancer (TROPiCS-02). 

The ASCENT study was supported by Immunomedics, a subsidiary of Gilead Sciences. 


Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med 2021; 384:1529-1541. DOI: 10.1056/NEJMoa2028485.



Συμπληρώστε το email σας για να λαμβάνετε τις σημαντικότερες ειδήσεις από το ogkologos.com

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like

Διαβαστε Επίσης

Καρκίνος και Κορωνοϊός (COVID-19) ΜΕΡΟΣ Α

Εάν είστε καρκινοπαθής, το ανοσοποιητικό σας σύστημα μπορεί να μην είναι τόσο ισχυρό όσο κανονικά, έτσι μπορεί να ανησυχείτε για τους κινδύνους που σχετίζονται...


Η Παγκόσμια Ημέρα Κατά του Καρκίνου καθιερώθηκε με πρωτοβουλία της Διεθνούς Ένωσης κατά του Καρκίνου (UICC), που εκπροσωπεί 800 οργανώσεις σε 155 χώρες του...


ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ) Γράφει ο Δρ Παπαδούρης Σάββας, Παθόλογος-Ογκολόγος   Ο ΜΜΚΠ βρίσκεται αναλογικά στο 80% και πλέον του συνολικού...

Διατρέχουν όντως οι καρκινοπαθείς μεγαλύτερο κίνδυνο λόγω κοροναϊού;

Σε πρακτικό επίπεδο, τα δεδομένα των σχετικών μελετών υποδηλώνουν ότι η χημειοθεραπεία ή οι άλλες αντι-νεοπλασματικές θεραπείες δεν αυξάνουν σημαντικά τον κίνδυνο θνησιμότητας από...

FDA: Η ακτινοβολία των smartphones δεν προκαλεί καρκίνο

Σε μια νέα έκθεσή της, η Υπηρεσία Τροφίμων και Φαρμάκων (FDA) των ΗΠΑ αναφέρει ότι επανεξέτασε τις σχετικές επιστημονικές έρευνες που δημοσιεύθηκαν τα τελευταία...

Νέα ανακάλυψη, νέα ελπίδα για τον καρκίνο

Ένα νεοανακαλυφθέν τμήμα του ανοσοποιητικού μας συστήματος θα μπορούσε να αξιοποιηθεί για την αντιμετώπιση όλων των ειδών καρκίνου, σύμφωνα με επιστήμονες του πανεπιστημίου Cardiff...
- Advertisment -

Ροή Ειδήσεων

10 Ways You Can Nurture A More Sustainable Garden

Sustainable gardening doesn’t have a firm, technical definition. It’s the concept of using sustainable gardening techniques that not only cause no harm to the...

Cancer Research UK spin-out gets US approval to trial unique T cell therapy

Cancer Research UK’s spin-out, GammaDelta Therapeutics (‘GammaDelta’), has been given approval from the US Food and Drug Administration (FDA) to trial its unique T-cell...

Platinum-Based Chemotherapy Versus Capecitabine in Patients With Residual TNBC Following Neoadjuvant Chemotherapy

The ECOG-ACRIN EA1131 study hypothesised that invasive disease-free survival (iDFS) would not be inferior but improved in patients with basal subtype triple-negative breast cancer...

Adding Checkpoint Inhibition to Anti-HER2 Breast Cancer Therapy Brings no Benefit [ESMO Virtual Plenary Press Release]

VP6-2021 - IMpassion050: A phase III study of neoadjuvant atezolizumab + pertuzumab + trastuzumab + chemotherapy (neoadj A + PH + CT) in high-risk,...

Breaking News: Supreme Court Upholds the Affordable Care Act

It’s a great day for cancer survivors. The Supreme Court of the United States (SCOTUS) upheld the Affordable Care Act (ACA), commonly known as...

How Does CAR T-Cell Therapy Work in Treating Cancer?

Craig A. Portell, MD, is an Associate Professor of Medicine at the University of Virginia and a member of the UVA Cancer Center in...