CDX-011: Phase II data

In 26 evaluable patients from the Phase II portion of a Phase I/II trial, 1.88 mg/kg IV CDX-011 met the primary endpoint, which required >=5 of 25 (20%) patients in the Phase II portion to be progression-free at 12 weeks. Specifically, 9 of 26 (25%) patients were progression-free at 12 weeks. Of 32 patients from the entire trial receiving 1.88 mg/kg CDX-011, 4 (13%) achieved confirmed or unconfirmed partial responses.

In 7 patients with GPNMB-expressing tumors, 2 confirmed partial responses were observed, 5 patients had a decrease tumor size and all 7 patients achieved at least stable disease for 17.3-26.9 weeks. Median progression-free survival (PFS) in all patients was 9.1 weeks, 18.3 weeks in patients with GPNMB-expressing tumors and 5.9 weeks for those that did not express GPNMB. In patients with triple negative disease, 5 of 7 analyzed samples expressed GPNMB, and 7 of 9 evaluable patients had tumor shrinkage with a median progression-free survival of 17.9 weeks. ...