Journal article
Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR)
The oncologist (Dayton, Ohio), Vol.26(7), pp.560-e1103
07/2021
DOI: 10.1002/onco.13777
PMCID: PMC8265348
PMID: 33829609
Abstract
The combination of carotuximab with axitinib did not provide a benefit over axitinib monotherapy in patients with metastatic clear cell renal cell carcinoma who had previously progressed on one or more vascular endothelial growth factor (VEGF)-targeted therapies. Exploratory evaluation of pretreatment circulating biomarkers suggested the combination might benefit patients who have low baseline VEGF levels.
Endoglin is an angiogenic receptor expressed on proliferating tumor vessels and renal cell carcinoma (RCC) stem cells that is implicated as a mechanism of resistance to vascular endothelial growth factor receptor (VEGFR) inhibitors. This study evaluated an antiendoglin monoclonal antibody (carotuximab, TRC105) combined with axitinib in patients with advanced or metastatic clear cell renal cell carcinoma (mccRCC) who had progressed following one or more prior VEGF inhibitors.
TRAXAR was a multicenter, international randomized 1:1 (stratified by ECOG, 0 vs. 1), phase II study of carotuximab combined with axitinib versus axitinib alone in mccRCC patients who had progressed following one or more prior VEGF inhibitors. The primary endpoint was progression-free survival (PFS) assessed by independent central review (ICR) per RECIST 1.1 RESULTS: A total of 150 patients were randomized. The combination therapy resulted in shorter median PFS by RECIST 1.1 than axitinib monotherapy (6.7 vs. 11.4 months). The combination was tolerated similarly to axitinib monotherapy, and there were no treatment related deaths. Exploratory evaluation of pretreatment circulating biomarkers suggested the combination might benefit patients who have low baseline VEGF levels.
The combination of carotuximab with axitinib did not demonstrate additional efficacy over single agent axitinib in patients with mccRCC who progressed following one or more prior VEGF inhibitor treatment.
Details
- Title: Subtitle
- Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR)
- Creators
- Toni K Choueiri - Dana-Farber Cancer InstituteYousef Zakharia - University of IowaSumanta Pal - City Of Hope National Medical CenterJudit Kocsis - Bács-Kiskun Megyei KórházRussell Pachynski - Washington University in St. LouisAlexandr Poprach - Masaryk Memorial Cancer InstituteAndrew B Nixon - Duke Medical CenterYingmiao Liu - Duke Medical CenterMark Starr - Duke Medical CenterJing Lyu - University of California, DavisKouros Owzar - Duke UniversityMollie deShazo - University of Alabama at BirminghamPrimo Lara - University of California Davis Medical CenterLajos Geczi - Országos Onkológiai Intézet, Budapest, HungaryThai H Ho - Mayo Clinic in ArizonaMeghara Walsh - Dana-Farber Cancer InstituteBonne Adams - Tracon PharmaceuticalsLiz Robertson - Tracon PharmaceuticalsMohamed Darif - Tracon PharmaceuticalsCharles Theuer - Tracon PharmaceuticalsNeeraj Agarwal - University of Utah
- Resource Type
- Journal article
- Publication Details
- The oncologist (Dayton, Ohio), Vol.26(7), pp.560-e1103
- DOI
- 10.1002/onco.13777
- PMID
- 33829609
- PMCID
- PMC8265348
- NLM abbreviation
- Oncologist
- ISSN
- 1083-7159
- eISSN
- 1549-490X
- Grant note
- P30 CA093373 / NCI NIH HHS
- Language
- English
- Date published
- 07/2021
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984548382102771
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