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March 27, 2014
05:48 EDTCLVSClovis CO-1686 shows compelling clinical activity, PFS in updated Phase 1 study
Clovis Oncology announced updated findings from the Phase 1 portion of its ongoing Phase 1/2 clinical study of CO-1686, the company’s novel, oral, targeted covalent inhibitor of mutant forms of the epidermal growth factor receptor, or 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. In the 22 evaluable T790M positive patients across efficacious dose levels, 14 RECIST partial responses, or PRs, have been observed to date, for a 64% objective response rate, or ORR. Ten of the 14 patients started CO-1686 therapy immediately following progression on a prior TKI. Twenty of the 22 evaluable T790M positive patients, or 91%, have experienced stable disease or a PR. The median duration of response cannot yet be estimated in the T790M positive patients. However, progression-free survival, or PFS, greater than six months has been observed in evaluable T790M positive heavily-pretreated patients and the median has not yet been reached. In contrast, PFS in T790M negative patients is shorter, with a median of three months. 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 most common adverse events were hyperglycemia, nausea, diarrhea, decreased appetite and vomiting, and these were mostly grade 1 in severity. The most common grade 3 adverse event was hyperglycemia, which was observed in 19% of patients. Hyperglycemia, when observed and requiring treatment, is typically asymptomatic and managed with a commonly prescribed single oral agent.
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