EHA 2019 – Nelarabine in the real-world, an effective option for relapsed/refractory T-acute lymphoblastic leukaemia/lymphoma


  • Cristina Ferrario - Agenzia Zoe
  • Univadis
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • In relapsed/refractory T-acute lymphoblastic leukaemia/lymphoma (R/R T-ALL/T-LBL), salvage therapy with nelarabine is an effective option in terms of overall response rate.
  • Nelarabine is also effective in bridging patients to allogeneic haematopoietic stem cell transplantation (Allo-SCT).
  • The safety profile is acceptable.

Why this matters

  • Outcomes for adult patients with R/R T-ALL/T-LBL are poor (5-year survival
  • No standard of care is available in this setting and data from clinical trials are limited.
  • There’s a need of data supporting the use of nelarabine, specifically approved as an orphan drug for these patients.

Study design

  • 118 adult patients with R/R T-ALL/T-LBL treated with at least one complete cycle of nelarabine (1,500 mg/sqm; Days 1,3,5) as salvage therapy in 27 haematologic sites were included in the observational, phase 4 study.
  • The overall response rate (ORR) and the overall survival (OS) were primary endpoints.
  • Additional endpoints included Allo-SCT rate after nelarabine, post-transplant OS and safety.

Key results

  • ORR in the whole population was 50%, with 36% and 14% of patients achieving complete remission (CR) and partial remission (PR), respectively.
  • OS for the entire population was 38% at 1 year (median survival 8 months).
  • Relapsing patients showed an advantage in OS compared to refractory patients.
  • 40% of patients (68% complete or partial response) underwent Allo-SCT after nelarabine and a better 1-year OS was observed in this population compared to non-transplanted patients (54% vs 22 %; log-rank P=0.0001; median survival 14.5 vs 4.8 months). 
  • 2- and 5-year OS after transplant were 46% and 38%, respectively
  • Response and Allo-SCT after treatment were the only factors affecting post-nelarabine OS.
  • A 5-year OS of 40% and a median survival of 22.5 months were observed in responders who also received Allo-SCT.
  • Nelarabine showed an acceptable safety profile with grade III/IV neurological events reported in 9% of patients.

Expert commentary

“Waiting for new treatments for R/R T-ALL/T-LBL, nelarabine can be considered an effective option and a good bridge to transplant. At the moment, no clear and complete data on mutational status are available in our population, but this is a very important issue and we think we will be able to collect these data in the future”. Anna Candoni, Division of Haematology and SCT, University of Udine, Udine, Italy.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit