AVL-301: Additional Phase I data

Clovis reported additional data from the first 62 patients treated with CO-1686 at efficacious doses - defined as twice-daily 900 mg doses of the free base capsule formulation or any dose of the hydrobromide salt tablet formulation - in the dose-escalation Phase I portion of an open-label, international Phase I/II trial. In 22 evaluable patients confirmed to have the dominant EGFR resistance mutation T790M, there were 14 partial responses (ORR=64%) and 6 cases of stable disease. In T790M-positive patients, PFS of greater than 6 months has been observed and median PFS has not yet been reached. Median PFS in T790M-negative patients was 3 months (n=12).

CO-1686 was well tolerated with only 1 patient discontinuing treatment due to adverse events. The most common adverse events were hyperglycemia, nausea, diarrhea, reduced appetite and vomiting, and the most common grade 3 adverse event was hyperglycemia. The trial enrolled patients with metastatic or unresectable recurrent NSCLC and a documented EGFR mutation who have progressed on prior EGFR-directed tyrosine kinase inhibitor (TKI) therapy. Data were presented at the European Lung Cancer meeting in Geneva. ...