MEIP just finished with their annual investor / analyst conference this evening and ASH on Saturday. There are a few issues at hand that have left me to believe that Pracinostat / Vidaza combination for Newly Diagnosed Elderly Patients with AML, may not be the combo that achieves a significant improvement over existing therapy for these patients. At least as far as overall survival may be concerned. The company has released positive interim CR (complete remission) data throughout the phase 2 AML trial. What we did not hear, up until the investor conference is below.
1. Six patients out of 41 had to have dose reduction. First Vidaza then Pracinostat reduced, with the majority being Vidaza reduced out of six.
2. The company is planning a 450 patient phase 3 AML trial in June 2015, with a planned primary end point being (CR) or complete response, for accelerated approval, and overall survival (OS) follow-up data for full approval. But the company said that discussions with the FDA is still ongoing, and will have to see if the CR is a valid primary endpoint for the filing of an NDA.
3. The age group for this AML phase 3 trial in elderly population is planning on being lowered from greater or equal to 65 years, down to greater or equal to 60 years of age.
The reason that the company is planning a phase 3 trial using CR as the endpoint could be because of the lowering of dose in the current trial. Patients may be exhibiting greater side effects than initially thought. If that is the case, the lowering of the dose could impact overall survival, and may be the reason that they are planning a phase 3 trial using CR as the primary endpoint rather than OS. There has to be a trade off between receiving enough of the drug for efficacy and the safety profile for the elderly population. In this case, with six patients, the lowering of the dosage of Vidaza to keep patients on therapy was the step taken. The inclusion criteria for the planned phase 3 trial of 60 years of age rather than the current trial design of 65 years, is another reason to believe that the combination may be too adverse for patients 65 years and older, and that an extra five year reduction could make the drug combination more tolerable.
1. Six patients out of 41 had to have dose reduction. First Vidaza then Pracinostat reduced, with the majority being Vidaza reduced out of six.
2. The company is planning a 450 patient phase 3 AML trial in June 2015, with a planned primary end point being (CR) or complete response, for accelerated approval, and overall survival (OS) follow-up data for full approval. But the company said that discussions with the FDA is still ongoing, and will have to see if the CR is a valid primary endpoint for the filing of an NDA.
3. The age group for this AML phase 3 trial in elderly population is planning on being lowered from greater or equal to 65 years, down to greater or equal to 60 years of age.
The reason that the company is planning a phase 3 trial using CR as the endpoint could be because of the lowering of dose in the current trial. Patients may be exhibiting greater side effects than initially thought. If that is the case, the lowering of the dose could impact overall survival, and may be the reason that they are planning a phase 3 trial using CR as the primary endpoint rather than OS. There has to be a trade off between receiving enough of the drug for efficacy and the safety profile for the elderly population. In this case, with six patients, the lowering of the dosage of Vidaza to keep patients on therapy was the step taken. The inclusion criteria for the planned phase 3 trial of 60 years of age rather than the current trial design of 65 years, is another reason to believe that the combination may be too adverse for patients 65 years and older, and that an extra five year reduction could make the drug combination more tolerable.
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