Zanubrutinib improves progression-free survival in relapsed CLL
Dana-Farber's Jennifer Brown, MD, PhD, says the phase 3 ALPINE randomized trial shows the drug zanubrutinib is superior to ibrutinib in relapsed/refractory chronic lymphocytic leukemia and should be considered a new standard of care.
I'm Doctor Jennifer Brown from dana Farber Cancer Institute. And I had the pleasure of presenting the Alpine study in the late breaking abstract session at ash this year. The Alpine study is a randomized phase three trial comparing Zanna brought it to a brutal nib. In patients with relapsed refractory Cll S. L. L. The patients as it turned out had a median of one prior chemo immunotherapy and otherwise a fairly typical un selected relapsed population. The primary endpoint of the study was overall response rate, which was significantly improved by Zanna Bruton compared to a brutal him. But what we presented at this meeting is the final analysis of progression free survival, which was significantly improved by Zanna Bruton compared to a brutal him at two years. The PFS was 12% better with san a brutal compared to a brutal in 79 versus 67%. So quite a significant difference. This was true across all subgroups, but particularly in the high risk deletion 17 P p 53 population, which was a preplanned analysis. There was a 22% improvement in progression free survival with Zanna Bruton compared to a prudent. In addition to this better efficacy. We also saw improved safety, particularly on the cardiac endpoints. The rate of atrial fibrillation was 5% with Zanna Bruton versus 13% with a brutal. There were fewer serious cardiac adverse events, fewer discontinuation due to cardiac events and there were no deaths on the santa brought in a farm of cardiac clauses versus six with a brutal. Additionally, across all adverse events, there were fewer treatment discontinuation fewer dose reductions and fewer dose interruptions with zanna Bruton compared to a brutal. There's no difference in overall survival between the arms at present. So the data demonstrate that santa brought in it has improved progression free survival compared to a brutal, in relapsed refractory Cll, with an even stronger effect in our highest risk patients. And this suggests that zanna Bruton can be considered a new standard of care in this setting.
