ARQL - FYE/4Q 2013 CC Notes
1. ARQL expects last patient enrolled in P3 METIV-HCC trial by mid-2016. An interim look will occur after 60-65% of pre-determined events occur and this will probably occur around the completion of enrollment (i.e., mid-2016).
2. In reference to the MetMab failure and the debate on MET as a target, management believes it is hard to transfer knowledge from one tumor type (NSCLC) to another (HCC). The P2 HCC trial involving tivantinib was the only one to include a MET inhibitor as a single-agent in a double-blind setting.
3. During Q&A, there was reference to it being unknown how close to initiation of MetMab therapy that Roche took the tissue sample to determine MET status. ARQL has a cut-off of 90 days and there was reference to this being a much shorter window than competitors (i.e., perhaps a more accurate assessment of MET status).
4. For P3 MARQUEE NSCLC trial, ARQL is still waiting to receive data for the EGFR mutant sub-group. There has been a slow rate of events in this sub-group.
5. For ARQ092 (AKT inhibitor), ARQL has learned to treat hypoglycemia before it arises (this was a DLT) and this allows them to push the dose of 092. They are evaluating different dosing schedules and haven't reached MTD yet. Most sign of activity has occurred in the 1 week on, 1 week off schedule. (I get the sense that management has the most excitement for ARQ092 in their pipeline beyond tivantinib.)
6. ARQ087 (FGFR inhibitor) may have utility in both FGFR mutations and where FGFR amplified. Pre-clinical data shows best efficacy in FGFR2 amplified and FGFR3 mutations.
7. ARQL is exploring potential of 092+087 as signaling through FGFR can activate the PI3K/AKT pathway.
