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ASH 2021 | GAIA/CLL13: venetoclax-based combination treatments vs standard chemoimmunotherapy in frontline CLL

Barbara Eichhorst, MD, University Hospital Cologne, Cologne, Germany, reports findings from the first co-primary endpoint analysis of the International Intergroup GAIA (CLL13) trial (NCT02950051). The GAIA (CLL13) trial evaluated the efficacy and safety of three time-limited venetoclax plus CD20 antibody-based regimens (obinutuzumab, obinutuzumab and ibrutinib and rituximab) in comparison to chemoimmunotherapy as a frontline treatment for fit patients with CLL and without TP53 mutation/deletion. At month 15, venetoclax plus obinutuzumab and venetoclax plus obinutuzumab and ibrutinib presented superior undetectable minimal residual disease (uMRD) rates in peripheral blood compared to chemoimmunotherapy. Finally, all cohorts showed a good safety profile. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.

Transcript (edited for clarity)

I was very fortunate to present this year the so-called GAIA trial, a Phase III trial, done in 920 patients where we have four different treatment arms. The standard arm is including either chemoimmunotherapy with FCR in patients up to the age of 65 years, or Bendamustine and Rituximab above that age. The three comparators include Venetoclax, all of them, and the first one for the co-primary endpoint includes Venetoclax plus Obinutuzumab, as approved in frontline treatment of CLL...

I was very fortunate to present this year the so-called GAIA trial, a Phase III trial, done in 920 patients where we have four different treatment arms. The standard arm is including either chemoimmunotherapy with FCR in patients up to the age of 65 years, or Bendamustine and Rituximab above that age. The three comparators include Venetoclax, all of them, and the first one for the co-primary endpoint includes Venetoclax plus Obinutuzumab, as approved in frontline treatment of CLL.

The second one includes Venetoclax, Obinutuzumab plus Ibrutinib, a triple combination where Ibrutinib may be given for up to 36 months due to, if patients have not reached undetectable MRD, and here the co-primary endpoint is a comparison of progression-free survival, and we had as an additional arm, which was not included in the co-primary analysis, Venetoclax plus Rituximab.

The results represented here with regard to the co-primary analysis of undetectable MRD, PFS events will… the PFS will follow next year, and with respect to MRD measured by conventional flow, we have seen a significantly higher rate of undetectable MRD three months after finishing Venetoclax, which was 86% with Venetoclax plus Obinutuzumab, versus 52% in the chemoimmunotherapy arm, and it was even higher with the triple combination. It was 82% with the triple combination, also at the same time point.

Yeah, we had… With respect to safety, maybe it’s worth to mention that we have seen with Venetoclax and Obinutuzumab a tendency less severe infections than with chemoimmunotherapy. With the triple treatment we have observed a tendency a few more severe infections, 22% versus 19% with chemoimmunotherapy, and among the infections was unfortunate there a few fungal infections as well.

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