MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial

Christiane Pott, Laurie H. Sehn, David Belada, John Gribben, Eva Hoster, Brad Kahl, Britta Kehden, Emmanuelle Nicolas-Virelizier, Nathalie Spielewoy, Guenter Fingerle-Rowson, Chris Harbron, Kirsten Mundt, Elisabeth Wassner-Fritsch, Bruce D. Cheson

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

Abstract

We report assessment of minimal residual disease (MRD) status and its association with outcome in rituximab-refractory follicular lymphoma (FL) in the randomized GADOLIN trial (NCT01059630). Patients received obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone. Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement) detected at study screening were assessed for MRD at mid-induction (MI), end of induction (EOI), and every 6–24 months post-EOI/discontinuation by real-time quantitative PCR. At MI, 41/52 (79%) patients receiving G-Benda were MRD-negative vs. 17/36 (47%) patients receiving Benda alone (p = 0.0029). At EOI, 54/63 (86%) patients receiving G-Benda were MRD-negative vs. 30/55 (55%) receiving Benda alone (p = 0.0002). MRD-negative patients at EOI had improved progression-free survival (HR, 0.33, 95% CI, 0.19–0.56, p < 0.0001) and overall survival (HR, 0.39, 95% CI, 0.19–0.78, p = 0.008) vs. MRD-positive patients, and maintained their MRD-negative status for longer if they received G maintenance than if they did not. These results suggest that the addition of G to Benda-based treatment during induction can significantly contribute to the speed and depth of response, and G maintenance in MRD-negative patients potentially delays lymphoma regrowth.

Original languageEnglish
Pages (from-to)522-532
Number of pages11
JournalLeukemia
Volume34
Issue number2
DOIs
StatePublished - Feb 1 2020

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