Re; ARRY (Ohad Hammer on ARRY at ASCO and its pipeline)
Sorry, I couldn't get the tables to print out here.
Array Biopharma – Maturing into a phase III company
Array (ARRY) had a transformative meeting thanks to positive results from its 2 MEK inhibitors, selumetinib and MEK162. Both drugs will probably advance to phase III trials in the coming 12 months.
Selumetinib, in development by AstraZeneca (AZN), had an impressive effect in lung cancer with KRAS mutations when added to standard chemotherapy. The drug increased response rate dramatically (35% vs. 0%) and PFS was more than doubled (5.3 vs. 2.1 months), compared to chemo alone. Both differences were statistically significant.
selumetinib-pfs.png
Source: Janne PA. ASCO 2012
Overall survival also increased dramatically (9.4 vs. 5.2 months) but the difference was not statistically significant, which is not surprising given the trial size. Based on this remarkable data set, which is in a prospectively predefined patient population, a phase III looks imminent.
MEK162 also generated a promising signal in a molecularly defined subset – melanoma with NRAS mutations. These patients (~15% of total patients) represent a highly unmet need as they are not candidates for BRAF inhibitors such as Roche’s Zelboraf. Of 28 evaluable patients, 18 had some level of tumor shrinkage, including 6 partial responses (3 confirmed). Although this activity is not as impressive as the ~50% response rate seen with BRAF inhibitors in BRAF mutated melanoma, it still merits pursuing MEK inhibitors in this subset of patients who have very limited treatment options. (Alone or in combination with other drugs).
mek162-melanoma.png
Source: Ascierto PA. ASCO 2012
Array is looking at an active remainder of 2012. As the field for MEK inhibitors is crowded (the leader is GSK’s trematinib), both AstraZeneca and Novartis will probably outline their registration strategies for their respective drugs later in 2012. The company also expects to present updated results for its 2 hematology drugs at ASH in December. I assume one of these is 614
Another catalyst this year could come from ARRY-797, a p38 inhibitor for pain, currently in a randomized phase II in osteoarthritis of the knee. Although no data have been published from the trial, p38 has been recently validated as a target for osteoarthritis of the knee by Flexion.
Flexion announced that its p38 inhibitor was efficacious in a randomized phase II study in osteoarthritis of the knee. Flexion’s approach differs from that of Array, as its drug is injected directly to the joints whereas Array’s drug is given as a pill. Flexion’s data implies that if ARRY-797 manages to reach the joints, it has a good chance of showing efficacy. Based on prior ARRY-797 trials, it has a very good safety profile, which could be an important distinguishing factor.
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