Interim data from an ongoing investigator-sponsored combination trial of ARRY-520 with Kyprolis in patients with relapsed or refractory MM who are refractory or intolerant to Velcade® (bortezomib) were also reported at the conference. The combination has demonstrated early signals of activity, with a 56% clinical benefit rate (≥MR). In addition, it has been well tolerated with limited hematologic toxicity and a manageable side effect profile.
ARRY-614 – FDA meeting provides guidance on primary endpointDuring the quarter, Array continued to evaluate ARRY-614 in an ongoing clinical trial in patients with low or intermediate-1 risk MDS using an optimized formulation. As presented at ASH, this new formulation has demonstrated improved bioavailability and target coverage in this patient population. With this new formulation, peak plasma concentrations and overall exposures are higher than with the original formulation. The ongoing Phase 1 dose escalation trial of the optimized ARRY-614 formulation may further our understanding of the contributions of these targets to the pathogenesis of MDS. In a prior study in a similar population, up to a 40% response rate for hematologic improvement was observed in patients.
Array also met with the FDA to discuss the development plan to support registration and received guidance from the FDA on the primary endpoint, including a discussion of endpoints other than overall survival that could be used as the basis for approval. Array has now defined a potential p
|SOURCE Array BioPharma Inc.|
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