ARRY - 1Q12 CC notes
1. Slide 13 (12:30 mark) - Management noted that in a recent Roche trial, DTIC showed overall survival in BRAF melanoma patients of about 8 months. The Phase 2 combo selumetinib trial in BRAF melanoma patients has still not reached the pre-specified number of events and top-line results are now not expected until 1H2012. (The trial completed enrollment over 18 months ago.)
2. ARRY-502 (asthma) - ARRY expects to enter into partnering discussions on this drug in 2012.
3. ARRY-520 (25 minute mark) - Kevin Koch made reference to the Phase 2 single-agent trial of 520 in multiple myeloma patients that are refractory to SoC (IMIDs, proteasomes, and dexamethasone). He said that ARRY "will show that the compound is efficacious in this patient population, which provides a fairly direct registration path." During Q&A, and a follow-up question that appeared to be directed to these comments, he noted that he didn't think there are enough patients in the Phase 2 trial that are going to be reported at ASH next month to allow for accelerated approval. He said he thinks ARRY would need at least 100 additional patients for potential accelerated approval and would likely need to compare results of 520+dexamethasone vs. 520 single-agent results to see if the data is there for an accelerated approval. There was also a reference to needing responses in the 20% range to be considered for accelerated approval. There are additional studies ongoing where 520 is being combined with Velcade or carfilzomib, which could enable registration paths in these relapsed refractory patient populations.
4. On or before ASCO 2012 we should have the full Phase 2 selumetinib results (both melanoma and NSCLC) and AZN's strategy for moving forward with selumetinib. Powering assumptions for both Phase 2 combo trials should also be released with the full results.
5. ARRY expects to retain North American rights for 520 and 614 for now and to ultimately partner ex-U.S. rights to both drugs.
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