Survival among patients with relapsed/refractory diffuse large B cell lymphoma treated with single-agent selinexor in the SADAL study

Marie Maerevoet*, Josee M. Zijlstra, George Follows, Rene Olivier Casasnovas, J. S.P. Vermaat, Nagesh Kalakonda, Andre Goy, Sylvain Choquet, Eric Van Den Neste, Brian Hill, Catherine Thieblemont, Federica Cavallo, Fatima De la Cruz, John Kuruvilla, Nada Hamad, Ulrich Jaeger, Paolo Caimi, Ronit Gurion, Krzysztof Warzocha, Sameer BakhshiJuan Manuel Sancho, Michael Schuster, Miklos Egyed, Fritz Offner, Theodoros P. Vassilakopoulos, Priyanka Samal, Matthew Ku, Xiwen Ma, Kelly Corona, Kamal Chamoun, Jatin Shah, Sharon Shacham, Michael G. Kauffman, Miguel Canales

*Corresponding author for this work

Research output: Contribution to journalLetterpeer-review

Abstract

Patients with RR DLBCL who have received ≥ 2 lines of therapy have limited treatment options and an expected overall survival (OS) of < 6 months. The SADAL study evaluated single-agent oral selinexor in patients with RR DLBCL and demonstrated an overall response rate (ORR) of 29.1% with median duration of response (DOR) of 9.3 months. The analyses described here evaluated a number of subpopulations in order to understand how response correlates with survival outcomes in order to identify patients who could most optimally benefit from selinexor treatment. Median age was 67 years; 44.8% of patients were ≥ 70 years of age. The median OS was 9.0 months (95% CI 6.2, 13.7) at a median follow-up of 14.8 months. The median OS was not reached in patients with a CR or PR, while patients who did not respond have a median OS of 4.9 months (p < 0.0001). Patients < 70 years had an OS of 11.1 months compared with 7.8 months in patients ≥ 70 years. Among patients with or without prior ASCT, the median OS was 10.9 and 7.8 months, respectively. Among patients with disease refractory to the most recent DLBCL treatment regimen, the median OS was 7.0 months compared with 11.1 months for disease not refractory to the most recent treatment. In a patient population in which survival is expected to be < 6 months, treatment with single-agent oral selinexor was associated with a median survival of 9 months. Increased median OS observed in patients responding to selinexor was consistent across subgroups regardless of age, prior ASCT therapy, or refractory status. Randomized studies of selinexor in combination with a variety of other anti-DLBCL agents are planned. This trial was registered at ClinicalTrials.gov (NCT02227251) on August 28, 2014. https://clinicaltrials.gov/ct2/show/NCT02227251.

Original languageEnglish
Article number111
JournalJournal of Hematology and Oncology
Volume14
Issue number1
DOIs
StatePublished - Dec 2021

Keywords

  • DLBCL
  • Exportin-1
  • SINE compounds
  • Selinexor

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