ARRY @ Jefferies (6/5/13)
1. There will be additional data next week at EHA on ARRY-520 relative to the combinability of 520 with carfilzomib (safety). The Phase 2 efficacy data of the combo will be presented in December at ASH.
2. ARRY previously talked about needing to combine 520 with Kyprolis or Velcade for full approval but mentioned here, for the first time I believe, the possibility of obtaining accelerated approval with this combo. I am curious if Squarer was hinting at the possibility of 520 obtaining AA based solely on the Phase 2 combo data of 520/carfilzomib that will report at ASH or the 520/Velcade data (not 100% sure if that data will be at ASH or later). Squarer did mention that in discussions with FDA that FDA believes 520 is an active drug and discussions have been positive.
3. The Phase 3 selumetinib KRAS NSCLC trial will begin dosing in October.
4. The Phase 3 selumetinib thyroid cancer trial has already begun dosing and AZN has moved selumetinib up into first-line in this pivotal study testing in combo with radioactive iodine as opposed to a refractory setting.
5. Memorial-Sloan Kettering has announced plans to initiate a 100-patient confirmatory, randomized uveal melanoma trial with selumetinib. ARRY hopes this will lead to approval of selumetinib in this indication.
6. Slide 9 compared the NVS/ARRY BRAF/MEK combo to that of the competition (GSK and Roche). ORR in BRAFi-naive was 88%, 76%, 92%, respectively. ORR in BRAFi-prior was 18%, N/A, 19%, respectively (showing similarity of NVS/ARRY combo to competition on efficacy front). On safety front, in attempting to show superiority of NVS/ARRY combo to GSK and Roche combos, fever was 0%, 71%, not reported, respectively. Rash was 3%, 27%, 53%, respectively. Diarrhea was 33%, 36%, and 51%, respectively. Chills was <10%, 58%, not reported, respectively. Fatigue was 23%, 53%, 30%, respectively.
