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Better survival with upfront autoSCT versus bortezomib-based intensification

Presented by
Prof. Michele Cavo, University of Bologna, Italy
ASH 2020
Phase 3, EMN02/HO95
At an extended median follow-up of 75 months, high-dose intensification therapy with autologous haematopoietic stem-cell transplantation (autoSCT) resulted in significantly longer overall survival (OS) in comparison with bortezomib-melphalan-prednisone (VMP). The OS benefit with autoSCT was preserved across subgroups of patients.

In the phase 3 EMN02/HO95 study (NCT01208766), newly diagnosed multiple myeloma (MM) patients were randomised to intensification therapy with either upfront autoSCT or VMP. Results of the final analysis demonstrated that progression-free survival (PFS) was significantly improved with autoSCT compared with VMP (median 57 vs 42 months; HR 0.73; adjusted P=0.0001). However, no difference between these groups was found in terms of secondary endpoint OS (HR 0.90; adjusted P=0.35) [1]. Thereafter, patients were re-randomised to consolidation therapy or no consolidation, followed by lenalidomide maintenance in both arms. Prof. Michele Cavo (University of Bologna, Italy) presented an updated analysis of the EMN02/HO95 study with longer-term follow-up [2].

Upfront autoSCT significantly prolonged OS (HR 0.80; 95% CI 0.66-0.98; adjusted P=0.034), PFS on next-line therapy (PFS2; HR 0.76; 95%CI 0.64-0.90; adjusted P=0.0016), and time to next treatment (HR 0.71; 95% CI 0.60-0.82; adjusted P<0.0001) compared with standard-dose intensification therapy with VMP. Median OS was not reached in both arms, and the 75-month survival estimate was 69% in the autoSCT group versus 63% in the VMP group (HR 0.81; 95% CI 0.66-0.98; adjusted P=0.034). Patients who benefited the most from randomisation to autoSCT were those with unfavourable prognostic characteristics at baseline. Overall, the 75-month OS estimate for patients with a high-risk cytogenetic profile was 54% with autoSCT versus 39% with VMP (HR 0.61; 95% CI 0.42-0.89; P=0.010). Patients randomised to VMP who received autoSCT delayed at the time of progression had a significantly shorter PFS2 and OS than those who were randomised to receive upfront autoSCT.

According to Prof. Cavo, these data support the continued use of upfront autoSCT in newly diagnosed MM patients who are fit for high-dose melphalan.

  1. Cavo M, et al. Lancet Haematol. 2020;7:e456-e468.
  2. Cavo M, et al. Upfront Autologous Hematopoietic Stem-Cell Transplantation Improves Overall Survival in Comparison with Bortezomib-Based Intensification Therapy in Newly Diagnosed Multiple Myeloma: Long-Term Follow-up Analysis of the Randomized Phase 3 EMN02/HO95 Study. 62nd ASH Annual Meeting, 5-8 December 2020. Abstract 142.

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