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ET OUTPERFORM | Price: $6.53 | Target Price: $8.00 INVESTMENT HIGHLIGHTS
Ariad Pharmaceuticals plans to initiate Phase II trial in chronic phase CML patients; reiterate our Market Outperform rating and $8 price target derived from our DCF and SOTP methodologies. The company announced that it will initiate Phase II studies in patients with refractory chronic-phase chronic myeloid leukemia (CP-CML) in mid-2015 after concluding discussions with the FDA and EU regulators. The planned trial will inform the optimal use of Iclusig in 450 patients. In light of the impressive efficacy results in the population in previous Phase II trials, we have confidence that this trial will inform the safe and effective use of Iclusig in this patient population.
Previous studies support the potential for class defining efficacy. Iclusig clinical activity as a second- and third-line CML agent has been thoroughly substantiated by the results of the Phase II PACE (Ponatinib Ph+ ALL and CML Evaluation) trial presented at ASCO and ASH in 2012. PACE was designed as a pivotal Phase II study to evaluate the safety and clinical activity of Iclusig (given at 45mg QD) in ~450 patients who were resistant or intolerant to either Tasigna or Sprycel, or were positive for T315I mutation following treatment with at least Gleevec. The trial was primarily comprised of patients with CP-CML (N=270), but also included patients with accelerated phase (AP)- CML (N=85) and blast phase (BP)-CML/Ph+ ALL (N=94). The primary and secondary endpoints for the trial included MCyR and MMR, respectively, for patients with CP-CML and major hematological response (MaHR) and MMR for patients with AP-/BP-CML/ Ph+ ALL.
Responses in PACE were striking given the extent to which this patient group had seen multiple prior therapies. Among patients with chronic phase CML, the rate of MCyR (the primary endpoint of the trial) was 56%, while the rate of MMR was 34% (Figure 1). Responses were greater among patients positive for the T315I resistance mutation (70% MCyR vs. 51%) among patients resistant or intolerant to either Tasigna or Sprycel and continued to improve with time on therapy. The rapidity and magnitude of the MCyR rates are also noteworthy in that they exceed the reported second-line response rates of Tasigna and Sprycel, in a patient population exposed to a greater number of prior therapies. The results among patients with T315I mutation alone would seem to put Iclusig in a class of its own with activity beyond the reach of its competitors.
Trial design reflective of previous studies. Maintaining control of CML in the chronic phase and prevention of progression to the accelerated and blast phase is crucial, and as mentioned, Iclusig has shown substantial cytogenetic benefit in this respect. This Phase II trial will largely reflect the trial design of the previous Phase II trial, and will focus on optimizing the risk-benefit ratio of Iclusig. Enrollment is targeted at 450 patients, randomized to receive once-daily 45, 30, or 15 mg Iclusig with a reduction to 15 mg
