Has IMpact been hoisted on its petard by the many faces of Janus?

[biopearl123]

Dr. Semerjian and Dr. Eid made several important points in today’s fireside chat. One was that the data safety and monitoring board meets 2 to 3 times a year and they strongly hinted that the study will be advised to continue to completion in 2028. This could be simply management of expectations with potential for a surprise or management of expectation in a different direction by saying it may actually take that long to reach the hoped for conclusion. This is a definite change in language from Dr. Scarlet, who basically said along with Faye and Dr. Rizzo that if the study showed dramatic results it would probably be halted at the time of the interim The potential reason for this was also hinted at with the explanation that now that there are multiple JAK inhibitors available, a patient might cycle through several Jack inhibitors before being declared refractory to Therapy. This means sicker patients much further along in their disease, much more likely to die because they came to Imetelstat therapy late. they could be laying the groundwork for the fact that Best available Therapy may not have changed much but pre enrollment therapy probably has.

[biopearl123]

Harut also adroitly side stepped revealing the internal hurdle for the interim analysis.

[rccola335]

I feel they are being conservative in what they say to avoid litigation, but if the interim analysis is strong, and another key will be the pathology and if they show bone marrow fibrosis reversal that I could see them getting an early approval

[biopearl123]

RC, that is very true. We know bone marrow fibrosis improvement is correlated with a better disease course. The BAT arm is very unlikely to show spontaneous fibrosis reversal. Imetelstat of course the opposite (maybe 20%?). But it has to correlate to OS improvement to support the primary end point.