surprised at the designation this was awarded (breakthrough). If your belief that this is not superior to sapa phase 2 and lead in data, shouldn't CYCC apply for this designation as well? could lead to a priority review?
Hi Value, a lot of regulatory events can happen for SAP/DAC in AML. However, we need to get to interim results. This is where we will get a good look at the randomized data ("around middle of next year"). In addition, expect us to partner at this point. Make no mistake, we have the best data elderly AML and we will prevail.
I'm sure the makers of Volasertib will be trying to enroll as many younger patients as possible because of the higher toxicity of the VOL/CYT combination regimen. Meanwhile, CYCC is probably trying to enroll as many 75+ patients in their study because of the lower toxicity of SAP/DAC. Volasertib is an attempt to thread the needle between intensive chemo and Sapacitabine. I don't think it will be very successful.
No, not in my view. In a 65+ population, MOS for Volasertib/Cytarabine is 8 months. In a 70-75 population, Sapacitabine/Dacogen MOS is 8.5 months. In a 75+ population, Sapacitabine/Dacogen MOS is 9.4 months. Because their combination regimen is toxic chemo (Cytarabine), their results will deteriorate in the older population sets. In addition they state the main side effect of the regimen is "Reversible Hematogical Toxicity". The problem is that their regimen is not suitable as "maintenance drug" because of this toxicity. For this reason the VOL/CYT regimen will not do well at the end of the curve. As Mr. Rombotis stated at the JMP conference, we have 20% still living 2-3 years out in the Pilot Arm. This is unprecedented in this population. So put simply, SAP/DAC is superior in an OLDER POPULATION than VOL/CYT in a YOUNGER POPULATION. ;o) When this news broke last week, it had no effect.