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Investigational Lung Cancer Drug Disappoints in Phase II Study

Treatment shows no difference from docetaxel (December 27)

Disappointing results have been reported from a phase II trial in patients with non–small-cell lung cancer (NSCLC). The new study showed no statistically significant difference in the rate of progression-free survival (PFS) between patients treated with AXL1717 (Axelar AB) compared with patients treated with docetaxel (Taxotere, Sanofi; and generics), confirming previously reported data.

A total of 101 patients with locally advanced or metastatic NSCLC (stage IIIB or IV) participated in the study. The primary objective was to compare the rate of PFS at 12 weeks between the AXL1717 and docetaxel groups. The 12-week PFS rates were 25.9% for AXL1717 and 39.0% for docetaxel in 99 treated patients. This difference was not statistically significant (P = 0.19).

The main secondary endpoints were PFS and overall survival (OS). Neither of these endpoints showed a statistically significant difference between the two treatment groups for all patients or for any of the histological subgroups. The OS results for patients with adenocarcinoma suggested a more favorable outcome following treatment with AXL1717 compared with the outcome for patients with squamous cell carcinoma.

Source: Axelar AB; December 27, 2013.

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