AXL1717: Final Phase II data

Final data from the open-label, international Phase II AXL-003 trial in 99 evaluable patients with previously treated, locally advanced or metastatic NSCLC showed that twice-daily oral AXL1717 for 21 days per cycle missed the primary endpoint of improving 12-week PFS rate vs. docetaxel (25.9% vs. 39%, p=0.19). AXL1717 also missed the secondary endpoints of improving median OS (7.52 vs. 9.41 months, p=0.91) and PFS (2.83 vs. 2.85 months, p=0.32) vs. docetaxel. In the subgroup of patients with adenocarcinoma (n=49), AXL1717 led to a median OS of 13.18 months vs. 5.7 months for docetaxel (p=0.75) and a median PFS of 2.99 months vs. 2.85 months for docetaxel (p=0.62). In the subgroup of patients with squamous cell carcinoma (SCC) (n=50), AXL1717 led to a median OS of 6.53 months vs. 9.41 months for docetaxel (p=0.63) and a median PFS of 2.83 months vs. 2.85 months for docetaxel (p=0.08). Patients with SCC had 1 prior line of therapy and patients with adenocarcinoma had 1-2 prior lines of therapy. Last April, the company reported interim data from the trial showing that AXL1717 led to a "similar" 12-week PFS rate as docetaxel, but declined to disclose details (see BioCentury, April 8, 2013). ...