12:00PM Array Biopharma provides clinical update on ARRY-614 for myelodysplastic syndromes at the 2013 American Society Of Hematology Meeting (ARRY) 5.48 -0.50 : Co announced updated clinical safety and efficacy data on ARRY-614 in patients with myelodysplastic syndromes (MDS) at the 2013 Annual Meeting of the American Society of Hematology. ARRY-614 is a potent inhibitor of p38/Tie2 with a mechanism of action distinct from drugs currently available to treat MDS. It is being studied in an ongoing dose-escalation trial in IPSS low/intermediate-1 risk MDS patients, representing a population of more than 100,000 patients in developed countries. The dose-escalation portion of the trial established the maximum tolerated dose, and subsequent expansion cohorts have been fully enrolled. Of patients currently evaluable for efficacy, 21% achieved a Hematologic Improvement, as defined by International Working Group 2006 (IWG). Of particular interest, 44% of platelet-transfusion dependent patients achieved Transfusion Reduction, and 31% achieved Transfusion Independence. Lower risk MDS patients with severe low platelet counts have a particularly poor prognosis. The most common treatment-related adverse events across all doses were rash (39%), nausea (17%), and atrial fibrillation (13%). The majority of these events were mild or moderate in severity.
8:34AM Array Biopharma provides clinical update on Filanesib for multiple myeloma (ARRY) 5.98 : Co reports positive data for newly named filanesib (ARRY-520) as a single agent and in combination with proteasome inhibitors (PI) in patients with multiple myeloma.
Phase 1b Dose Escalation Trial -- Filanesib in Combination with Kyprolis
Interim data from an ongoing investigator initiated combination trial of filanesib with Kyprolis in patients with relapsed or refractory MM were reported at the conference. 100% of these patients were refractory or intolerant to Velcade, while 80% were refractory or intolerant to Revlimid and 30% had received prior treatment with filanesib or Kyprolis. The combination demonstrated early signs of activity, with a 37% overall response rate and 63% clinical benefit rate. In addition, the trial demonstrated that filanesib and Kyprolis can be combined at the maximum planned dose for each agent. The combination has been well tolerated with hematologic toxicity effectively managed with supportive measures.
Phase 1b Dose Escalation Trial -- Filanesib in Combination with Velcade
Interim data from an ongoing combination trial of filanesib with Velcade in patients with relapsed or refractory MM were reported at the conference. These patients had relapsed or refractory disease to Velcade with a median of five prior treatments. The combination demonstrated early signs of activity with a 42% ORR in patients dosed at greater than or equal to 1.25 mg/m2 filanesib in Schedule 1 (filanesib administered on Days 1, 2, 15 and 16 every 4 weeks). For the subset of Velcade-sensitive patients, the ORR was 63%, while for PI-refractory patients it was 30%. In addition, the trial demonstrated that filanesib and Velcade can be combined at the maximum planned dose for each agent. The combination has been well tolerated with limited hematologic toxicity effectively managed with supportive measures. There was a low incidence of non-hematologic adverse events which were predominantly Grade 1 / 2 and there was a very low incidence of peripheral neuropathy.
Phase 2 Trial -- Filanesib Single Agent and in Combination with Dexamethasone
Mature data from a Phase 2 trial in heavily pretreated MM patients were reported at the conference. In patients with a median of six prior therapies, previously treated with both Velcade and Revlimid, single-agent filanesib demonstrated a 16% ORR. In patients with a median of eight prior therapies, who were dual refractory to Velcade and Revlimid, filanesib in combination with dexamethasone demonstrated a 15% ORR. There was a low incidence of non-hematologic adverse events, including no peripheral neuropathy. Hematologic toxicities were characterized as transient, non-cumulative and asymptomatic and were effectively managed with supportive measures.
In addition, the retrospective use of AAG levels as a patient selection marker improved the ORR results to 24% of patients receiving single-agent filanesib and 19% of dual-refractory patients receiving filanesib and dexamethasone. In the single-agent portion of the trial, median overall survival in AAG-low patients was 23.3 months.
Also of note, filanesib demonstrated clinical activity in patients previously treated with newer myeloma agents, including Kyprolis, MLN9708 and/or Pomalyst, suggesting filanesib maintains activity in patients resistant to multiple PI and IMiD drugs. In this population, filanesib had an ORR of 21% which improved to 33% in an AAG-selected population.
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