Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer

• DOI: 10.1007/s10549-022-06602-7
• Publication Date: 2022-05-11T19:25:15Z
• Authors: Joyce O’Shaughnessy; Adam Brufsky; Hope S. Rugo; Sara M. Tolaney; Kevin Punie; Sagar Sardesai; Erika Hamilton; Delphine Loirat; Tiffany Traina; Roberto Leon-Ferre; Sara A. Hurvitz; Kevin Kalinsky; Aditya Bardia; Stephanie Henry; Ingrid Mayer; Yanni Zhu; See Phan; Javier Cortés
• Keywords: Triple-negative breast cancer; Clinical endpoint

Abstract Purpose Sacituzumab govitecan (SG) is an antibody–drug conjugate composed of anti–Trop-2 antibody coupled to SN-38 via a proprietary hydrolyzable linker. In the ASCENT study, SG improved survival versus single-agent treatment physician’s choice (TPC) in pre-treated metastatic triple-negative breast cancer (mTNBC). Hormone/HER2 receptor changes are common, particularly at relapse/metastasis. This subanalysis assessed outcomes patients who did/did not have TNBC initial diagnosis, before enrollment. Methods diagnosis was only required study entry. Patients with mTNBC refractory/relapsing after ≥ 2 prior chemotherapies were randomized 1:1 receive or TPC. Primary endpoint progression-free (PFS) without brain metastases. Results Overall, 70/235 (30%) and 76/233 (33%) received TPC, respectively, did diagnosis. Clinical benefit TPC observed this subset. Median PFS 4.6 2.3 months (HR 0.48; 95% CI 0.32–0.72), median overall 12.4 6.7 0.44; 0.30–0.64), objective response rate (ORR) 31% 4%; those also CDK4/6 inhibitors had ORRs 21% 5%. Efficacy safety for generally similar present Conclusion clinical manageable profile SG, supporting as option regardless subtype Subtype reassessment advanced allows optimal treatment. trial registration number NCT02574455, registered October 12, 2015.