ASH 2021 | Update on GAIA trial
Arnon Kater, MD, PhD, University of Amsterdam, Amsterdam, Netherlands, discusses the GAIA trial (NCT02950051), in which physically fit patients with previously untreated chronic lymphocytic leukemia (CLL) who did not have a TP53 or Del(17p) mutation, were assigned to one of four treatment arms – standard chemoimmunotherapy (FCR or BR), venetoclax plus rituximab, venetoclax plus obinutuzumab, or obinutuzumab plus venetoclax plus inbrutinib. The primary endpoints were minimal residual disease (MRD) negativity rate in peripheral blood and progression-free survival (PFS). This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.
Transcript (edited for clarity)
So this year, we have three oral talks about trials that we’ve been doing, I was included in that. First is the biggest trial, I think, which is the German trial, the GAIA trial, which is a collaboration of a German working group together with the HOVON, and the Nordic study group. In this study four treatment arms were included and the study had more than 900 patients.
The first one is for fit patients though, either FCR or BR when you are older, but still fit enough...
So this year, we have three oral talks about trials that we’ve been doing, I was included in that. First is the biggest trial, I think, which is the German trial, the GAIA trial, which is a collaboration of a German working group together with the HOVON, and the Nordic study group. In this study four treatment arms were included and the study had more than 900 patients.
The first one is for fit patients though, either FCR or BR when you are older, but still fit enough. The second arm was venetoclax and rituximab. The third one was venetoclax and obinutuzumab, and the fourth one was a combination of venetoclax and obinutuzumab and also ibrutinib.
But we heard, tomorrow it’s all very short data yet, so progression-free survival date and everything that’s a bit too early, but what we can say already is that levels of MRD significantly differed between the two arms, where the combination treatment with obinutuzumab and venetoclax, and also with ibrutinib, actually gave the strongest undetectable MRD rates, more than venetoclax, rituximab, and certainly more than chemo-immunotherapy.
Whether all these fixed duration treatments will indeed also, at the end, result in very different progression-free survival data, I think it will, because we know that MRD in this combination is a very predictive marker, but that’s still a bit too early to say.
Read more...
