I think the most surprising thing in this report is that not everyone responds - "The overall response rate at that time was 84% in treatment-naïve patients and 88% in relapsed or refractory patients."
You would think particularly in the treatment naive cohort there would be an almost 100% at least partial response to this combination.
It is worth noting that between the two 25 person cohorts, only one person progressed with their disease and one died (although its not clear what the cause of death was from this blurb).
I dont think overall response rate includes those who do not progress and have stable disease. So at least it appears there is still benefit from the drugs to even those who do not have some overall response. In two years of follow up only one person progressed, so overall still a very hopeful study.
So to put a more happy face on the report of the phase two trial, 48 out of 50 benefitted from the combination with only one person progressing and a second dying of some cause that is not clear, at least in this report.
At the age most of us are when we are diagnosed with cll, if you pick any random group of fifty people one or two might not make it two years out.
Its a very promising study, realistically we know at this point not every treatment will work for everyone of us. 88% ORR in the relapsed group is impressive, higher than the treatment naive group. I think the treatment naive group will fare a lot better than the relapsed group in a larger study. This is a small sample size for both groups.
When it is said that a Phase III trial is being run in "cooperative group tasks" is that clinical experiences? And, is that also a way for clinicians to be the ones testing by lowering or temporarily stopping one or more of the meds---giving data, then that might not be available from the Phase II trial?
I did not know you could take all 3 in the US. I thought it’s only in trials??? (It was offered to me in a randomized trial.) Did your CLL specialist give it to you?
if your willing to pay the co-pays all is possible in usa, after awhile i figured out ways to get 2/3 of the bills paid. for it. Was also not a planned sequence,
started imbruvica January 2019, added venclexta december 2019, started gazyva may 2020 and last dose oct 2020.. still on imbruvica /venclexta.
Response rates are nice. Overall response (OS) rate is what really counts . For that you have to wait. How we sequence drugs, which combos and when, is the research we need, but won't get from PHRMA. It's a chess game. No-one resigns or checkmates immediately after opening pawn to king's 4,. It's the following moves that determines if you are a winner.
OS looking good with the three-year update to this study at ASH 2020.
"The medians for PFS and OS were not reached (Figure 1). The 36- month estimated PFS is 95% (95% CI: 72-99%) for TN and 95% (95% CI: 69-99%) for RR patients. The 36-month estimated OS is 95% (95% CI: 72-99) for TN and 100% for RR patients."
Three-Year Follow-up from a Phase 2 Study of Combination Obinutuzumab, Ibrutinib, and Venetoclax in Chronic Lymphocytic Leukemia
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