Ariad Pharmaceuticals Inc fka ARIA

[DonShimoda]

Hi 2Da,

Also, is there any data on how long the PFS interval is for Sarcoma patients under existing protocols, i.e. without mTOR treatment (or placebo)?

Your question goes right to the heart of the matter. In rida's P2, 90% of pts were progressing at time of enrollment. In a heavily pre-treated patient group such as this, one would expect a 6 month PFR of around 14%( See pdf Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas).

In 4 major subgroups rida demonstrated significantly higher activity with CBR of 30%, 33%, 30%, and 23% for bone sarcoma, leiomyosarcoma, liposarcoma and other, respectively. So we can conclude that rida is active in pts whose disease is progressing, however, the phase 3 trial enrolled pts who were disease stable so no direct comparison with the phase 2 results is possible.

However, I would argue that in rida's p2 trial, ariad was able to identify an opportunity to treat sarcoma in a maintenance setting for pts who are disease stable following a favorable response to chemotherapy. The fact that 29% (61 of 212) patients in the Phase 2 trial achieved a PFS rate at six months of 70% which was "nearly triple that of the overall population" cannot be easily explained away.