8:44AM ArQule: Data presented at European cancer congress suggest clinical benefit of Tivantinib in patients with MET high non-squamous non-small cell lung cancer (ARQL) 2.57 : In the intent-to-treat population of 1048 patients in MARQUEE, median overall survival (OS) in the treatment arm of tivantinib plus erlotinib was 8.5 months versus 7.8 months in the erlotinib only control arm, while median progression free survival (PFS) was 3.6 months in the treatment arm versus 1.9 months in the control arm.
Objective response rate was 10.3 percent in the treatment arm compared to 6.5 percent in the control arm. Median OS for patients with MET High NSCLC in the treatment arm was 9.3 months compared to 5.9 months in the control arm, and median PFS for the treatment arm was 3.6 months compared to 1.9 months for the control arm.
ORR was 10.6 percent for patients with MET-high NSCLC in the treatment arm versus 6.5 percent in the control arm. Median OS for patients with MET Low NSCLC in the treatment arm was 8.5 months compared to 7.7 months in the control arm, and median PFS for the treatment arm was 3.7 months compared to 1.9 months for the control arm (hazard ratio = 0.66, p = 0.006.
ORR was 11.2 percent for patients with MET-low NSCLC in the treatment arm versus 5.5 percent in the control arm. The overall safety profile among patients receiving tivantinib (360 milligrams twice daily) and erlotinib (150 milligrams daily) was manageable and consistent with findings at the interim analysis.
On December 19, 2008, ArQule and Daiichi Sankyo, Co., Ltd. signed a license, co-development and co-commercialization agreement to co-develop tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin Co., Ltd. has exclusive rights for development and commercialization.
