Pharma Strategy Blog

"ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo Co., Ltd. (TSE 4568) today announced that they will move forward with a Phase 3 clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer (NSCLC).

In connection with this decision, the sponsor company, Daiichi Sankyo, will file a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for a trial comparing ARQ 197 plus erlotinib against erlotinib plus placebo."

Source: ArQule

This is promising news from ArQule and their partner Daiichi Sankyo, which one of my Twitter buddies kindly alerted me to this morning (Thank You, you know who you are!).

Many of you may remember the blog post earlier this year discussing the phase II results. The data was a little odd in that they saw a fairly large improvement in PFS from 9.7 to 16.1 weeks when used in combination with erlotinib (Tarceva), which is clinically significant but without the P-value hitting significance.

Dr West from Swedish did a very nice overview of the data on his lung cancer site, GRACE, which is well worth reading for those interested.  I particularly loved this quote from his post:

"This work is also looking only at patients who haven’t received an EGFR inhibitor before. It may be that ARQ 197 and/or another c-MET inhibitor could restore activity and clinical benefit for patients who previously responded to an EGFR inhibitor and then progressed from acquired resistance. That concept remains to be demonstrated, but the concept is certainly appealing."

I'm also keen to see what the data from a larger sample size would show and whether there are any useful molecular markers involved.  There are a myriad of other interesting questions:

• Must all the people entering the study have MET/EGFR or KRAS amplification?
• Did any of the patients in the phase II trial have/develop the ALK or T790M mutation?
• Was the EGFR mutation present as WT or mutated?
• Were there any particular features of the people who responded versus those who did not?

The list could go on and on, but likely the study would be underpowered in phase II to tell us any of that important information.  If it does, I can't wait for more extensive analysis!

There are numerous other c-MET inhibitors in pipeline development (at least 11 or 12 that I know of), but ArQule's appears to be the most advanced to date.