32LBA The AGITG ICECREAM Study: The Irinotecan Cetuximab Evaluation and Cetuximab Response Evaluation Amongst Patients with a G13D Mutation – analysis of outcomes in patients with refractory metastatic colorectal cancer harbouring the KRAS G13D mutation

Methods: Based on the presence of molecular alterations, pts are treated with a MTT (among sorafenib, everolimus, pazopanib, lapatinib, nilotinib). After 12 weeks of treatment (induction period), pts with objective response are proposed to continue the MTT, while pts with stable disease are randomly assigned (1:1, maintenance period) to continuation or interruption of MTT. Analyses are carried out per MTT cohort using a sequential Bayesian approach. Primary endpoint of the induction period is the 12-week progression-free rate (PFR12w as per RECIST1.1). Secondary endpoints include toxicity and PFS. This abstract reports the preliminary results of the induction period for the sorafenib and everolimus cohorts. Results: From Feb.2014 to Apr. 2015, 48 and 30 pts were enrolled and evaluable at 12 weeks in the sorafenib and everolimus cohorts, respectively. The PFR12w were 32% and 29% in the sorafenib and everolimus cohorts, respectively. The PFR12w according to molecular alterations are presented in Table 1. No major safety issues were reported. Updated PFS will be presented at the meeting. Conclusion: This molecular-driven approach warrants further investigation in specific molecular subtypes. Clinical trial information: NCT02029001 No conflict of interest.