Durable ibrutinib responses in relapsed/refractory marginal zone lymphoma: long-term follow-up and biomarker analysis. - Université de Lille
Article Dans Une Revue Blood Advances Année : 2020

Durable ibrutinib responses in relapsed/refractory marginal zone lymphoma: long-term follow-up and biomarker analysis.

A. Noy
  • Fonction : Auteur
S. de Vos
  • Fonction : Auteur
M. Coleman
  • Fonction : Auteur
P. Martin
  • Fonction : Auteur
C. R. Flowers
  • Fonction : Auteur
G. P. Collins
  • Fonction : Auteur
S. Ma
  • Fonction : Auteur
S. Peles
  • Fonction : Auteur
S. D. Smith
  • Fonction : Auteur
J. C. Barrientos
  • Fonction : Auteur
E. Chong
  • Fonction : Auteur
S. Wu
  • Fonction : Auteur
L. W. Cheung
  • Fonction : Auteur
K. Kwei
  • Fonction : Auteur
B. Hauns
  • Fonction : Auteur
I. Arango-Hisijara
  • Fonction : Auteur
R. Chen
  • Fonction : Auteur

Résumé

Advanced marginal zone lymphoma (MZL) is an incurable B-cell malignancy dependent on B-cell receptor signaling. The phase 2 PCYC-1121 study demonstrated the safety and efficacy of single-agent ibrutinib 560 mg/d in 63 patients with relapsed/refractory MZL treated with prior rituximab (RTX) or rituximab-based chemoimmunotherapy (RTX-CIT). We report the final analysis of PCYC-1121 with median follow-up of 33.1 months (range: 1.4-44.6). Overall response rate (ORR) was 58%; median duration of response (DOR) was 27.6 months (95% confidence interval [CI]: 12.1 to not estimable [NE]); median progression-free survival (PFS) was 15.7 months (95% CI: 12.2-30.4); and median overall survival (OS) was not reached (95% CI: NE to NE). Patients with prior RTX treatment had better outcomes (ORR: 81%; median DOR: not reached [95% CI: 12.2 to NE]; median PFS: 30.4 months [95% CI: 22.1 to NE]; median OS: not reached [95% CI: 30.3 to NE]) vs those with prior RTX-CIT treatment (ORR: 51%; DOR: 12.4 months [95% CI: 2.8 to NE]; PFS: 13.8 months [95% CI: 8.3-22.5]; OS: not reached [95% CI: NE to NE]). ORRs were 63%, 47%, and 62% for extranodal, nodal, and splenic subtypes, respectively. With up to 45 months of ibrutinib treatment, the safety profile remained consistent with prior reports. The most common grade ≥3 event was anemia (16%). Exploratory biomarker analysis showed NF-κB pathway gene mutations correlated with outcomes. Final analysis of PCYC-1121 demonstrated long-term safety and efficacy of ibrutinib in patients with relapsed/refractory MZL, regardless of prior treatment or MZL subtype.

Dates et versions

hal-04212078 , version 1 (20-09-2023)

Identifiants

Citer

A. Noy, S. de Vos, M. Coleman, P. Martin, C. R. Flowers, et al.. Durable ibrutinib responses in relapsed/refractory marginal zone lymphoma: long-term follow-up and biomarker analysis.. Blood Advances, 2020, Blood Advances, 4 (22), pp.5773-5784. ⟨10.1182/bloodadvances.2020003121⟩. ⟨hal-04212078⟩

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