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Efficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer.
Santin, Alessandro D; Corr, Bradley R; Spira, Alexander; Willmott, Lyndsay; Butrynski, James; Tse, Ka Yu; Patel, Jilpa; Mekan, Sabeen; Wu, Tia; Lin, Kai-Wen; Kuo, Peiwen; Dumbrava, Ecaterina E.
Afiliación
  • Santin AD; Yale School of Medicine, New Haven, CT.
  • Corr BR; University of Colorado Cancer Center, Aurora, CO.
  • Spira A; Virginia Cancer Specialists, Fairfax, VA.
  • Willmott L; HonorHealth Virginia G. Piper Cancer Care Network Biltmore, Phoenix, AZ.
  • Butrynski J; Willamette Valley Cancer Institute and Research Center, Eugene, OR.
  • Tse KY; School of Clinical Medicine, The University of Hong Kong, Hong Kong, China.
  • Patel J; Gilead Sciences, Inc, Foster City, CA.
  • Mekan S; Gilead Sciences, Inc, Foster City, CA.
  • Wu T; Gilead Sciences, Inc, Foster City, CA.
  • Lin KW; Gilead Sciences, Inc, Foster City, CA.
  • Kuo P; Gilead Sciences, Inc, Foster City, CA.
  • Dumbrava EE; The University of Texas MD Anderson Cancer Center, Houston, TX.
J Clin Oncol ; : JCO2302767, 2024 Jul 31.
Article en En | MEDLINE | ID: mdl-39083724
ABSTRACT

PURPOSE:

Patients with advanced endometrial cancer (EC) who progress on or after platinum-based therapy and immunotherapy have poor prognosis. We report efficacy and safety of sacituzumab govitecan (SG), a trophoblast cell-surface antigen 2 (Trop-2)-directed antibody-drug conjugate, in patients with advanced EC.

METHODS:

TROPiCS-03 (ClinicalTrials.gov identifier NCT03964727) is a multicohort, open-label, phase II basket study in patients with metastatic solid tumors. Eligible patients in the EC cohort received SG 10 mg/kg once on days 1 and 8 every 3 weeks. Primary end point was objective response rate (ORR) by investigator's assessment per RECIST v1.1. Secondary end points included clinical benefit rate (CBR; complete and partial response, and stable disease ≥6 months), duration of response (DOR), and progression-free survival (PFS) per investigator assessment, overall survival, and safety. Trop-2 expression of archival or baseline tumor specimens was analyzed by immunohistochemistry.

RESULTS:

At data extraction date, 41 patients were enrolled. Median follow-up was 5.8 months (range, 0.7-19.3); median previous therapies was three (range, 1-6); and 85% of patients received previous chemotherapy and immunotherapy. ORR was 22% (95% CI, 11 to 38); CBR was 32% (95% CI, 18 to 48). Median DOR was 8.8 months (95% CI, 2.8 to not estimable); median PFS was 4.8 months (95% CI, 2.8 to 9.8). Trop-2 exploratory analysis was conducted retrospectively for 39 patients. Tumor Trop-2 protein was highly expressed in EC, showing limited correlation with efficacy. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 73% of patients. Study drug discontinuation due to TRAEs was 5%. Two deaths occurred, deemed unrelated to SG.

CONCLUSION:

Findings from TROPiCS-03 showed encouraging efficacy of SG with a manageable toxicity profile in a heavily pretreated population with advanced EC. Safety findings were consistent with the known SG safety profile.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Clin Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Clin Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos