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.
On a conference call to discuss the data, the company said a "rational way forward" would be to evaluate AXL1717 as third-line treatment of NSCLC. Axelar said it is "planning future studies in parallel with ongoing partner discussions," but could not be reached for details. AXL1717 is an oral small molecule insulin-like growth factor-1 (IGF-1) receptor (IGF1R; CD221) inhibitor, though the company said there is evidence that AXL1717 also suppresses tumor cell division by arresting cells in mitosis.
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