Daiichi Sankyo And ArQule Expand Collaboration On Heels Of Positive ARQ 197 News
This article was originally published in PharmAsia News
Executive Summary
TOKYO - Daiichi Sankyo and ArQule announced a flurry of activity surrounding their oncology collaboration, including regulatory and clinical updates for c-Met inhibitor ARQ 197 and expansion of their drug discovery program based on ArQule kinase inhibitor platform (AKIP) technology
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TOKYO - Daiichi Sankyo and ArQule announced a flurry of activity surrounding their oncology collaboration, including regulatory and clinical updates for c-Met inhibitor ARQ 197 and expansion of their drug discovery program based on ArQule kinase inhibitor platform (AKIP) technology. The companies said Oct. 11 they will proceed later this year with a pivotal Phase III trial of ARQ 197 for non-small cell lung cancer under a special protocol assessment with U.S. FDA. The trial will enroll patients with locally advanced or metastatic NSCLC of nonsquamous histology. On the same day, ArQule presented positive Phase II results of ARQ 197 at the annual meeting of the European Society for Medical Oncology. Patients treated with ARQ 197 plus Tarceva (erlotinib) had a median time to develop new metastases of 7.3 months, compared to a median time of 3.6 months for patients treated with erlotinib plus placebo. ARQ 197 performed better among patients with non-squamous histology, with a median time of 11 months. The Phase III trial for ARQ 197 will use a primary endpoint of overall survival for the intent-to-treat population, with secondary endpoints of overall survival in the epidermal growth factor receptor wild-type subpopulation and progression-free survival in the intent-to-treat population. Research Collaboration Expands Targets Daiichi Sankyo announced the next day it expanded the research collaboration with ArQule, an indication of the Tokyo company's satisfaction with the collaboration's progress. The companies added a third therapeutic target for use under ArQule's AKIP technology, and included an option for a fourth target, while adding a two-year extension to their agreement. Daiichi Sankyo has the option to license any compounds related to the therapeutic targets during a specified period in preclinical development, and ArQule has the option to co-commercialize those products in the U.S. In a press statement, Arqule said the initial discovery collaboration - set in 2008 - has identified a drug candidate for one of the two original kinase inhibitor targets and is optimizing lead compounds for the second target. Daiichi Sankyo paid $75 million upfront for ARQ 197 plus undisclosed milestones, and the Japanese company is financing the discovery platform plus undisclosed milestones and royalties (Also see "ArQule Signs c-Met Inhibitor, Discovery Platform Deals With Daiichi Sankyo" - Scrip, 14 Nov, 2008.). UBS analyst Christopher Schaefer said in an Oct. 11 analyst note that the Phase II data presented at ESMO will "aid in the validation of c-Met playing a role in tumor metastases," but added that there are a number of upcoming events to watch to track ARQ 197's progress: initiating the pivotal trial for ARQ 197 for NSCLC by the fourth quarter of this year; Phase II results for ARQ 197 in second-line hepatocellular carcinoma, expected in 2011; and Phase I/II results of ARQ 197 plus Nexavar (sorafenib) in hepatocellular carcinoma, also expected in 2011. Kyowa Hakko Kirin - which holds development commercialization rights for ARQ 197 in Japan, China, South Korea and Taiwan - began a Phase II trial of the drug for gastric cancer at the end of July (Also see "Kyowa Hakko Kirin Pins Rebound On KW-0761 For Oncology And Allergy Indications" - Scrip, 29 Jul, 2010.). - Daniel Poppy ([email protected]) [Editor's note: Daiichi Sankyo Senior Director Jim Toole and ArQule VP John Celebi will discuss ARQ 197 and their discovery platform collaboration as part of a Japanese dealmaking panel at the PharmAsia Summit, Oct. 25-26 at the Intercontinental Mark Hopkins in San Francisco. Click here for more details.] |