Monday, September 27, 2010 4:08:32 AM
On SGN-35 pivotal data in relapsed or refractory HL
What they probably need for approval in efficacy terms is ORR higher than 25-30% and durability longer than 5-6 months. I'm sure they will do better than that although not as good as in phase I (because trials design was very much alike but in the pivotal trial one of the Inclusion Criteria was: "Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant" while in the phase I trial not all patients got the transplant).
PS it's is already Mon. morning at my side of the globe
What they probably need for approval in efficacy terms is ORR higher than 25-30% and durability longer than 5-6 months. I'm sure they will do better than that although not as good as in phase I (because trials design was very much alike but in the pivotal trial one of the Inclusion Criteria was: "Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant" while in the phase I trial not all patients got the transplant).
PS it's is already Mon. morning at my side of the globe
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