Supplemental tables and figures from Phase II Study of the Dual EGFR/HER3 Inhibitor Duligotuzumab (MEHD7945A) versus Cetuximab in Combination with FOLFIRI in Second-Line RAS Wild-Type Metastatic Colorectal Cancer

Hill, Andrew G.; Findlay, Michael P.; Burge, Matthew E.; Jackson, Christopher; Alfonso, Pilar Garcia; Samuel, Leslie; Ganju, Vinod; Karthaus, Meinolf; Amatu, Alessio; Jeffery, Mark; Bartolomeo, Maria Di; Bridgewater, John; Coveler, Andrew L.; Hidalgo, Manuel; Kapp, Amy V.; Sufan, Roxana I.; McCall, Bruce B.; Hanley, William D.; Penuel, Elicia M.; Pirzkall, Andrea; Tabernero, Josep

doi:10.1158/1078-0432.22464057.v1

Supplemental tables and figures from Phase II Study of the Dual EGFR/HER3 Inhibitor Duligotuzumab (MEHD7945A) versus Cetuximab in Combination with FOLFIRI in Second-Line RAS Wild-Type Metastatic Colorectal Cancer

journal contribution

posted on 2023-03-31, 19:41 authored by Andrew G. Hill, Michael P. Findlay, Matthew E. Burge, Christopher Jackson, Pilar Garcia Alfonso, Leslie Samuel, Vinod Ganju, Meinolf Karthaus, Alessio Amatu, Mark Jeffery, Maria Di Bartolomeo, John Bridgewater, Andrew L. Coveler, Manuel Hidalgo, Amy V. Kapp, Roxana I. Sufan, Bruce B. McCall, William D. Hanley, Elicia M. Penuel, Andrea Pirzkall, Josep Tabernero

Supplemental tables and figures Supplemental Table 1. Study drug exposure. Supplemental Table 2. Select AEs at relatively high frequency led to disproportionately more frequent irinotecan/5-FU dose changes (reduced, interrupted, or withdrawn) on the duligotuzumab arm. Supplemental Figure 1. CONSORT patient flow diagram

History

ARTICLE ABSTRACT

Purpose: Duligotuzumab is a dual-action antibody directed against EGFR and HER3.Experimental Design: Metastatic colorectal cancer (mCRC) patients with KRAS ex2 wild-type received duligotuzumab or cetuximab and FOLFIRI until progression or intolerable toxicity. Mandatory tumor samples underwent mutation and biomarker analysis. Efficacy analysis was conducted in patients with RAS exon 2/3 wild-type tumors.Results: Of 134 randomly assigned patients, 98 had RAS ex2/3 wild-type. Duligotuzumab provided no progression-free survival (PFS) or overall survival (OS) benefit compared with cetuximab, although there was a trend for a lower objective response rate (ORR) in the duligotuzumab arm. No relationship was seen between PFS or ORR and ERBB3, NRG1, or AREG expression. There were fewer skin rash events for duligotuzumab but more diarrhea. Although the incidence of grade ≥3 AEs was similar, the frequency of serious AEs was higher for duligotuzumab.Conclusions: Duligotuzumab plus FOLFIRI did not appear to improve the outcomes in patients with RAS exon 2/3 wild-type mCRC compared with cetuximab + FOLFIRI. Clin Cancer Res; 24(10); 2276–84. ©2018 AACR.

Usage metrics

Keywords

Clinical Trial Results Gastrointestinal Cancers Colorectal cancer Hematological Cancers

Licence

CC BY

Supplemental tables and figures from Phase II Study of the Dual EGFR/HER3 Inhibitor Duligotuzumab (MEHD7945A) versus Cetuximab in Combination with FOLFIRI in Second-Line RAS Wild-Type Metastatic Colorectal Cancer

History

ARTICLE ABSTRACT

Usage metrics

Categories

Keywords

Licence

Exports