Tuesday, February 26, 2013

New Trials coming up for BMS anti-PD1 (BMS 936558)!!

Information attained from a talk and slides given by Dr. Jeffery Weber in Canada on Feb. 21....

FUTURE PLANS:  BMS 936588 (Formerly known as MDX 1106)

Phase II trial of simultaneous anti-PD1 and Ipi

Phase II trial of sequential reciprocal anti-PD1 and ipi.  [I think this means that some people would get ipi first followed by anti-PD1, while others would get anti-PD1, followed by ipi.]

Phase III 2:1 randomized second line trial  of anti-PD1 at 3mg/kg vs investigator's choice of chemo

Phase III randomized first line trial of anti-PD1 at 3mg/kg vs dacarbazine (ex-US) [I think that means outside the US.]

Phase III randomized first line trial of anti-PD1 at 3mg/kg vs ipi and vs the combo

Personal comments:

Dr. Weber has mentioned the ipi and anti-PD1 combo to me before.  He has high hopes for its outcomes, but is worried about combined side effects.

Dr. Weber told me a good while back, when I asked about the "dream study" he would like to conduct, that he would like to complete a "sandwich study" (his term) of the combined or sequential effect of ipi and anti-PD1.  Looks like most of these offerings work to answer that dream.

Remember, that in my study we have been given this very anti-PD1 product (BMS 936558) at 1, 3 and 10mg/kg with no evidence (so far) of increased effect with greater dose, though WITH slightly greater side effects at the higher dosing levels....keeping in mind that this is very preliminary.  I am in the 1mg/kg cohort of a Phase 1 trial...whose purpose (as is true for all Phase 1 trials) is to determine optimum dosing.

Please forgive me if, when writing about the BMS anti-PD1 product....BMS 936558 (formerly known as MDX1106), I have to restrain myself from saying....OR "the artist formerly known as Prince"!!!

Good luck.  Remember to check: http://www.Clinicaltrials.gov for current availability and requirements for these trials. - c


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