- 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.
- 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).
- 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.
- Short follow-up.
- Roche France.