Clinical Results and Biomarker Analyses of Axitinib and TRC105
versus Axitinib Alone in Patients with Advanced or Metastatic
Renal Cell Carcinoma (TRAXAR)

J 2021

Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR)

CHOUEIRI, T. K., Y. ZAKHARIA, S. PAL, J. KOCSIS, R.. PACHYNSKI et. al.

Basic information

Original name

Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR)

Authors

CHOUEIRI, T. K. (guarantor), Y. ZAKHARIA, S. PAL, J. KOCSIS, R.. PACHYNSKI, Alexandr POPRACH (203 Czech Republic, belonging to the institution), A. B. NIXON, Y. M. LIU, M. STARR, J. LYU, K. OWZAR, M. DESHAZO, P. LARA, L. GECZI, T. H. HO, M. WALSH, B. ADAMS, L. ROBERTSON, M. DARIF, C. THEUER and N. AGARWAL

Edition

ONCOLOGIST, DURHAM, ALPHAMED PRESS, 2021, 1083-7159

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.837

RIV identification code

RIV/00216224:14110/21:00122124

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1002/onco.13777

UT WoS

000645142400001

Keywords in English

Phase II; TRAXAR; Axitinib; Renal cell cancer; Endoglin; TRC105; Carotuximab

Abstract

V originále

Lessons Learned 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. Background 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. Methods 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. Conclusion 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.

Citovat

CHOUEIRI, T. K., Y. ZAKHARIA, S. PAL, J. KOCSIS, R.. PACHYNSKI, Alexandr POPRACH, A. B. NIXON, Y. M. LIU, M. STARR, J. LYU, K. OWZAR, M. DESHAZO, P. LARA, L. GECZI, T. H. HO, M. WALSH, B. ADAMS, L. ROBERTSON, M. DARIF, C. THEUER and N. AGARWAL. Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR). ONCOLOGIST. DURHAM: ALPHAMED PRESS, 2021, vol. 26, No 7, p. "560"-"e1103", 7 pp. ISSN 1083-7159. Available from: https://dx.doi.org/10.1002/onco.13777.

@article{1786842,
   author = {Choueiri, T. K. and Zakharia, Y. and Pal, S. and Kocsis, J. and Pachynski, R.. and Poprach, Alexandr and Nixon, A. B. and Liu, Y. M. and Starr, M. and Lyu, J. and Owzar, K. and DeShazo, M. and Lara, P. and Geczi, L. and Ho, T. H. and Walsh, M. and Adams, B. and Robertson, L. and Darif, M. and Theuer, C. and Agarwal, N.},
   article_location = {DURHAM},
   article_number = {7},
   doi = {http://dx.doi.org/10.1002/onco.13777},
   keywords = {Phase II; TRAXAR; Axitinib; Renal cell cancer; Endoglin; TRC105; Carotuximab},
   language = {eng},
   issn = {1083-7159},
   journal = {ONCOLOGIST},
   title = {Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR)},
   url = {https://theoncologist.onlinelibrary.wiley.com/doi/epdf/10.1002/onco.13777},
   volume = {26},
   year = {2021}
}

TY  - JOUR
ID  - 1786842
AU  - Choueiri, T. K. - Zakharia, Y. - Pal, S. - Kocsis, J. - Pachynski, R.. - Poprach, Alexandr - Nixon, A. B. - Liu, Y. M. - Starr, M. - Lyu, J. - Owzar, K. - DeShazo, M. - Lara, P. - Geczi, L. - Ho, T. H. - Walsh, M. - Adams, B. - Robertson, L. - Darif, M. - Theuer, C. - Agarwal, N.
PY  - 2021
TI  - Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR)
JF  - ONCOLOGIST
VL  - 26
IS  - 7
SP  - "560"-"e1103"
EP  - "560"-"e1103"
PB  - ALPHAMED PRESS
SN  - 10837159
KW  - Phase II
KW  - TRAXAR
KW  - Axitinib
KW  - Renal cell cancer
KW  - Endoglin
KW  - TRC105
KW  - Carotuximab
UR  - https://theoncologist.onlinelibrary.wiley.com/doi/epdf/10.1002/onco.13777
N2  - Lessons Learned 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. Background 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. Methods 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. Conclusion 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.
ER  -

CHOUEIRI, T. K., Y. ZAKHARIA, S. PAL, J. KOCSIS, R.. PACHYNSKI, Alexandr POPRACH, A. B. NIXON, Y. M. LIU, M. STARR, J. LYU, K. OWZAR, M. DESHAZO, P. LARA, L. GECZI, T. H. HO, M. WALSH, B. ADAMS, L. ROBERTSON, M. DARIF, C. THEUER and N. AGARWAL. Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR). \textit{ONCOLOGIST}. DURHAM: ALPHAMED PRESS, 2021, vol.~26, No~7, p.~''560''-''e1103'', 7 pp. ISSN~1083-7159. Available from: https://dx.doi.org/10.1002/onco.13777.

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