ArQule (ARQL -17.2%) slumps on increased volume in early trade in apparent response to a just-released abstract on blood cancer candidate ARQ 531, a reversible BTK inhibitor, that will be presented at ASH next month.
Interim results from a dose-escalation Phase 1 clinical trial showed partial responses in 10 patients, mostly in the higher dose cohorts. On the safety front, however, there were serious and life-threatening treatment-related adverse events, including decreased neutrophil count, febrile neutropenia, cellulitis, decreased platelet count, increased lipase and rash. The highest dose of 75 mg once-daily appeared to be too toxic so the 65 mg dose will be used in the expansion phase, although one patient experienced dose-limiting toxicity with 65 mg (serious rash).
Investors appear to be reacting to how well ARQ 531 compares to Eli Lilly’s (LLY +1.5%) LOXO-305, also a reversible BTK inhibitor. Phase 1 data also showed preliminary efficacy but with a more favorable safety profile. All treatment-related adverse events were mild or moderate with no dose-limiting toxicities.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.