BTH1677 in combination with cetuximab with and without irinotecan in patients with advanced metastatic colorectal cancer

Aim: Investigate the safety, pharmacokinetics (PK) and efficacy of BTH1677/cetuximab, with and without irinotecan, in patients with metastatic colorectal cancer (mCRC). Patients & methods: Patients with recurrent or progressive mCRC were assigned to BTH1677/cetuximab/irinotecan (group 1; n = 10) or BTH1677/cetuximab (group 2; n = 22). Adverse events, PK parameters and tumor response were assessed. Results & conclusion: Adverse events were consistent with those expected of the backbone therapy of cetuximab/irinotecan (group 1) or cetuximab alone (group 2). The BTH1677 PK profiles were similar in the two groups. The overall response rates were 30.0% (group 1) and 22.7% (group 2); in KRAS wild-type subset analysis, rates were 42.9% and 45.5%, respectively. BTH1677 therapy was tolerable and warrants further evaluation for treatment of mCRC.