ARIAD Pharmaceuticals: -534 Data Impresses at ASH
We are reiterating our 1-OW on ARIA following presentation of Phase I data for pan Bcr-Abl inhibitor -534 in advanced hematological cancers at ASH. Data presented in heavily pretreated CML pts including pts with the T315I mutation were impressive and supportive of a partnership and future regulatory and commercial potential.
With primary focus on efficacy, in 20 evaluable chronic phase (CP) pts, -534 achieved 25% complete and 45% major cytogenetic responses (CyR's) with a 83% complete hematologic response (CHR). In 12 evaluable CP pts with the T315I mutation, -534 achieved a CHR in all pts and a major CyR in 43% of pts. 28 pts still remain on drug in the study including 9/10 CP pts with the T315I mutation. While there may be a focus on the AE profile and in particular 3 pts with QTc prolongation, we would note that 2nd line agent Sprycel has a QTc warning while Tasigna has a boxed warning in the label.
ARIA has suggested initiation of a registration study in 2H10. With Phase III SUCCEED data for Ridaforolimus in sarcoma also expected in 1Q/3Q10, ARIA could potentially establish itself as a company with two late-stage assets in 2010.
