AVL-301: Additional Phase I/II data

Clovis reported additional data from 81 evaluable 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 an open-label, international Phase I/II trial. In 40 patients confirmed to have the EGFR resistance mutation T790M, there were 23 partial responses (ORR=58%) and 13 cases of stable disease. In T790M-positive patients, estimated PFS is >12 months and median PFS has not yet been reached. Median duration of response has also not been reached.

The most common grade 3 adverse event was hyperglycemia, which occurred in 22% of patients. The 81 patients included 72 patients from the dose-escalation Phase I portion and 9 from the ongoing Phase II portion. 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 American Society of Clinical Oncology meeting in Chicago. Clovis reported data from the Phase I portion earlier this year (see BioCentury, April 21 & May 9). ...