Another disappointment with Daiichi Sankyo and ArQule's tivantinib

14 January 2013

US drug developer ArQule (Nasdaq: ARQL) saw its shares plunge 23% to $2.25 in premarket trading on Friday, as the company, along with partner Japanese pharma major Daiichi Sankyo (TSE 4568) announced disappointing top-line results of a randomized Phase II signal generation trial of tivantinib (ARQ 197) used in combination with irinotecan and cetuximab in patients with refractory or relapsed colorectal cancer (CRC).

This is the second disappointment regarding the compound; last fall, the companies announced they were halting a Phase III study in non-small cell lung cancer (NSCLC) of tivantinib after independent monitors concluded the drug would not meet its endpoint of prolonging overall patient survival (The Pharma Letter October 3, 2012).

Missed primary endpoint of PFS

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