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ARTICLE | Clinical News

Axelar's AXL1717 misses in Phase II NSCLC trial

December 27, 2013 11:23 PM UTC

Axelar AB (Solna, Sweden) said twice-daily oral AXL1717 missed the primary endpoint of improving the 12-week progression-free survival (PFS) rate vs. docetaxel in the Phase II AXL-003 trial to treat non-small cell lung cancer (NSCLC) (25.9% vs. 39%, p=0.19). AXL1717 also missed the secondary endpoints of improving median overall survival (OS) (7.52 vs. 9.41 months, p=0.91) and PFS (2.83 vs. 2.85 months, p=0.32) vs. docetaxel. Axelar said some early episodes of neutropenia in the AXL1717 arm developed into serious events, some of which were fatal.

In April, Axelar reported interim data from the trial showing that AXL1717 led to a "similar" 12-week PFS rate as docetaxel, but the company declined to disclose details. The open-label, international trial enrolled 99 evaluable patients with previously treated, locally advanced or metastatic NSCLC. ...