Karolinska's Axelar comes up short in Phase II with lung cancer drug

Swedish biotech Axelar's lung cancer drug failed to beat out standard docetaxel in a mid-stage trial, but bankroller Karolinska Development ($KDEV) isn't giving up, planning to keep studying the drug in hopes of finding a partner.

In a Phase II trial on 101 patients, AXL1717 couldn't significantly increase progression-free survival in patients with non-small cell lung cancer, the company said--at 12 weeks, the PFS rate for Axelar's drug was just 25.9% compared to 39.0% in the docetaxel group. The drug missed the mark in its secondary endpoint of overall survival as well.

But Karolinska Development still believes its portfolio company can find a partner to take AXL1717 forward, and Axelar said it has new data showing that a second mechanism of action gives the drug some promise in patients who have relapsed after treatment with docetaxel.

"There is increasing evidence that AXL1717, in addition to the IGF-1R pathway inhibition, also suppresses tumor cell division by arresting cells in mitosis through a non-IGF-1R-dependent mechanism," CEO Mikael von Euler said in a statement. "This proposed additional mechanism of action would explain the differences in efficacy and side effect profile compared with other substances inhibiting the IGF-1R pathway."

Axelar plans to divulge some of that new data at scientific meetings next year, the company said, but until then, the once-vaunted AXL1717 looks less than promising.

Back in April, Axelar was so convinced of its drug's chances of proving noninferiority to docetaxel that it wrapped up Phase II enrollment early, stopping at 101 patients instead of the earlier-planned 140. That move sent Karolinska Development's shares to a 20-month high of $30.60. After an up-and-down autumn, the company traded at around $31 on Monday.

- read the statement