ArQule's tivantinib misses in colorectal cancer

ArQule Inc. (NASDAQ:ARQL) fell $0.34 (12%) to $2.58 on Friday after the company and partner Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) said twice-daily oral tivantinib missed the primary endpoint in a Phase II trial to treat relapsed or refractory metastatic colorectal cancer (mCRC). Tivantinib plus irinotecan and Erbitux cetuximab did not significantly improve progression-free survival (PFS) vs. placebo plus irinotecan and Erbitux (8.3 vs. 7.3 months). The partners said that PFS in both treatment arms was longer than expected compared to "previously published historical norms." The double-blind, international trial enrolled 122 patients with unresectable, wild-type K-Ras (KRAS) mCRC who had received front-line systemic therapy. ArQule said the partners plan to continue discussions with key opinion leaders to determine how best to proceed with further development of tivantinib in colorectal cancer.

Last year, ArQule and Asian partner Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) discontinued the Asian Phase III ATTENTION trial of tivantinib to treat non-small cell lung cancer (NSCLC) of non-squamous histology based on a recommendation by the trial's safety committee. ArQule and Daiichi Sankyo, its partner outside of Asia, also discontinued the Phase III MARQUEE trial of tivantinib in NSCLC patients after an interim analysis showed tivantinib would miss the primary endpoint of overall survival (OS) (see BioCentury, Sept. 10, 2012). ...