4.4 Article

TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2-metastatic breast cancer

Journal

FUTURE ONCOLOGY
Volume 16, Issue 12, Pages 705-715

Publisher

FUTURE MEDICINE LTD
DOI: 10.2217/fon-2020-0163

Keywords

antibody-drug conjugate; HER2-negative; HR-positive; MBC; metastatic breast cancer; sacituzumab govitecan; SN-38; Trop-2

Categories

Funding

  1. Immunomedics, Inc.
  2. Pfizer
  3. Novartis
  4. Eli Lilly
  5. F. Hoffmann-La Roche
  6. Macrogenics
  7. Merck
  8. OBI Pharma
  9. Eisai
  10. Daiichi Sankyo
  11. Odonate
  12. Seattle Genetics
  13. Genentech/F Hoffman-La Roche
  14. Sanofi
  15. Radius Health
  16. Immunomedics
  17. Mersana Therapeutics
  18. Innocrin Pharmaceuticals
  19. Biothernostics
  20. AstraZeneca
  21. Nektar Therapeutics
  22. Genentech/F. Hoffmann-La Roche
  23. NanoString Technologies
  24. Exelixis
  25. Cyclacel
  26. Bristol-Myers Squibb
  27. Bayer HealthCare Pharmaceuticals
  28. Takeda
  29. F Hoffmann-La Roche
  30. ARIAD Pharmaceuticals
  31. Baxalta GMBH/Servier Affaires
  32. Guardant Health
  33. Merck Sharp Dohme
  34. PIQUR Therapeutics
  35. Puma Biotechnology
  36. Queen Mary University of London
  37. GlaxoSmithKline
  38. Contessa
  39. Merck, Sharp Dohme
  40. Genentech/F Hoffmann-La Roche
  41. OncoGenex Pharmaceuticals

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Patients with HR+/HER2- metastatic breast cancer (MBC) whose cancers have progressed despite conventional therapies represent an unmet clinical need. Trop-2, a transmembrane calcium signal transducer, is highly expressed in MBC and plays a role in tumor growth and progression. Sacituzumab govitecan (SG) is a novel antibody-drug conjugate comprising an Trop-2 antibody coupled to SN-38, the active metabolite of irinotecan, via a unique hydrolyzable linker. SG has demonstrated promising activity in a Phase I/II IMMU-132-01 basket study in heavily pretreated solid tumors, including HR+/HER2- MBC. We describe the registrational Phase III TROPiCS-02 study (NCT03901339), evaluating SG versus treatment of physician's choice in HR+/HER2- MBC. Trial registration number: NCT03901339.

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