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ARTICLE | Clinical News

Tarloxotinib: Development discontinued

November 18, 2016 6:32 PM UTC

Threshold discontinued development of tarloxotinib after reporting interim data from the Phase II TH-CR-601 and TH-CR-602 trials of the compound to treat NSCLC and squamous cell carcinoma of the head and neck (SCCHN) or skin (SCCS), respectively. Data from 21 evaluable patients with EGFR-mutant, T790M-negative, advanced NSCLC in the first stage of the open-label, U.S. and Australian TH-CR-601 trial showed that tarloxotinib missed the primary interim response rate threshold, defined as a partial or complete response in ≥4 out of 19 patients, for expanding enrollment into the next stage of the trial. Specifically, tarloxotinib led to no confirmed partial responses and 7 cases of stable disease.

Data from a cohort of 22 patients with recurrent or metastatic SCCHN in the first stage of the open-label, U.S. and Australian TH-CR-602 trial showed that tarloxotinib missed the primary interim response rate threshold for expanding enrollment into the next stage of the trial. Specifically, tarloxotinib led to no confirmed partial responses and 8 cases of stable disease. Threshold said tarloxotinib did meet the primary interim response rate threshold for expanding enrollment in a cohort of 7 patients with recurrent or metastatic SCCS, with 1 partial response reported. Threshold has exclusive, worldwide rights to tarloxotinib from the University of Auckland under a 2014 deal...