Ariad Pharmaceuticals ARIA issued a corporate update press release today (4/4/2013). The main focused was CML drug ICLUSIG (ponatinib), but there were also more updates, discussion, and color regarding their ALK/EGFR inhibitor AP26113 than I expected (learn more about ALK inhibitors in development here). Therefore, I'll summarize these below along with any additional color from the conference call.
- The Phase 1 portion of our Phase 1/2 clinical trial of AP26113 is ongoing, and we expect to transition into the four Phase 2 expansion cohorts [crizotinib-naive ALK+ NSCLC, crizotinib-resistant ALK+ NSCLC, EGFR-mutant NSCLC resistant to at least one EGFR inhibitor, and other ALK+ or ROS fusion tumors] in the second quarter of 2013.
- A fifth Phase 2 cohort in ALK-positive NSCLC patients with brain metastases is also being planned [big problem - over 50% of NSCLC failures, including crizotinib failures. No comment on whether these patients will have had crizotinib already...Excited about CNS activity that has been seen with '113. Best way to characterize activity was to study separately in phase 2...not to say these patients won't be part of broader ALK registrational strategy...no comment on entry criteria for pivotal trial until it starts...no comment on if they are seeing brain met responses in the dose escalation phase].
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Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Additional disclosure: Dr. Goodwin is prohibited from trading biopharma stocks by his employer.