The Breakthrough Therapy designation was granted based on interim efficacy and safety results from an ongoing Phase I/II study of CO-1686. CO-1686 is the company’s novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M.
Clovis Oncology president and CEO Patrick Mahaffy said that the company is very much appreciate this designation by FDA, which recognizes the meaningful benefit CO-1686 may provide patients with T790M positive NSCLC.
"This designation is well timed for us as well, as the increased interaction with FDA that it provides will come as we are initiating our registration studies and preparing to submit our initial New Drug Application (NDA) by mid-2015," Mahaffy added.
Interim results from an ongoing Phase I/II study of CO-1686 were presented at the 4th European Lung Cancer Conference (ELCC) in Geneva in late March.
An objective response rate of 64 percent in 14 of 22 evaluable T790M positive patients was observed. CO-1686 is well-tolerated, with only one patient who discontinued treatment with CO-1686 due to adverse events. There was no evidence of systemic wild-type EGFR inhibition.
The next update of CO-1686 clinical data will be presented at the 2014 American Society of Clinical Oncology Annual Meeting in a Clinical Science Symposium titled, "Targeting EGFR: The Next 10 Years", taking place on 31 May 2014 in Chicago.
The company is currently enrolling two Phase II expansion cohorts of its Phase I/II study in EGFR mutant patients with the T790M mutation.
Data from the expansion cohorts, combined with data from the TIGER2 study, in T790M positive patients directly after progression on their first and only TKI therapy, are expected to serve as the basis of an NDA submission for CO-1686 by mid-2015.