EHA 2019 – Induction with obinutuzumab plus DHAP in mantle cell lymphoma leads to a high level of minimal residual disease negativity


  • Cristina Ferrario — Agenzia Zoe
  • Univadis
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Takeaway

  • An induction regimen with obinutuzumab plus high-dose aracytine (HA) and salt platinum-containing (P) chemotherapy (O-DHAP) is highly effective, leading 75% of not previously treated patients with mantle cell lymphoma (MCL) to minimal residual disease (MRD) negativity in the bone marrow (BM).
  • The regimen is safe and no major toxicity has been reported.

Why this matters

  • A prolonged MRD negativity after both induction and autologous stem cell transplantation (ASCT) is an independent prognostic marker in MCL, useful in clinical practice.
  • The standard of care for untreated younger patients with MCL is based on rituximab plus DHAP followed by ASCT consolidation plus 3 years of maintenance with rituximab.
  • In vitro data suggest that obinutuzumab may be better than rituximab in providing anti-MCL activity, but no data in naive MCL patients are available.

Study design

  • The prospective and open phase 2 trial enrolled 86 patients.
  • Induction consisted of 4 cycles of O-DHAP before consolidation with ASCT followed by obinutuzumab maintenance for 3 years then obinutuzumab on-demand for MRD positive patients.
  • The primary objective was the efficacy of upfront O-DHAP assessed at the molecular level (MRD in BM by IG qPCR) after induction, and quantification with a sensitivity of at least 10-4 was reached by dd-PCR.
  • Secondary objectives also included progression-free survival (PFS) and overall survival (OS).

Key results

  • The median follow-up at the time of the analysis was 14 months.
  • 73 patients were MRD-informative and 62 of them reached MRD negativity in the dd-PCR analysis (85%).
  • 75% of the 71 tested patients reached MRD negativity by qPCR.
  • Data on PFS and OS are encouraging, but still immature.

Limitations

  • Short follow-up.

Funding

  • Roche France.