Title :

Obinutuzumab and idelalisib in symptomatic patients with relapsed/refractory Waldenström macroglobulinemia.

Author(s) :

Tomowiak, C. [Auteur]
Poulain, Stéphanie [Auteur]
Cancer Heterogeneity, Plasticity and Resistance to Therapies (CANTHER) - UMR 9020 - UMR 1277
Herbaux, Charles [Auteur]
Perrot, A. [Auteur]
Mahé, B. [Auteur]
Morel, Pierre [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Aurran, T. [Auteur]
Tournilhac, O. [Auteur]
Leprêtre, S. [Auteur]
Assaad, S. [Auteur]
Villemagne, B. [Auteur]
Casasnovas, O. [Auteur]
Nollet, D. [Auteur]
Roos-Weil, D. [Auteur]
Chevret, S. [Auteur]
Leblond, V. [Auteur]

Journal title :

Blood Advances

Abbreviated title :

Blood Adv

Volume number :

5

Pages :

p. 2438-2446

Publication date :

2021-05-11

ISSN :

2473-9537

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

We present the results of a phase 2 study evaluating the combination of obinutuzumab + idelalisib in relapsed/refractory (R/R) Waldenström macroglobulinemia (WM). The goal was to determine the safety and efficacy of a ...
Show more >We present the results of a phase 2 study evaluating the combination of obinutuzumab + idelalisib in relapsed/refractory (R/R) Waldenström macroglobulinemia (WM). The goal was to determine the safety and efficacy of a fixed-duration chemotherapy-free treatment. During the induction phase, patients received idelalisib + obinutuzumab for 6 cycles, followed by a maintenance phase with idelalisib alone for ≤2 years. Forty-eight patients with R/R WM were treated with the induction combination, and 27 patients participated in the maintenance phase. The best responses, reached after a median of 6.5 months (interquartile range, 3.4-7.1; range, 2.6-22.1 months), were very good partial response in 5 patients, partial response in 27 patients, and minor response in 3 patients, leading to overall response rate and major response rate estimates of 71.4% (95% confidence interval [CI], 56.7-83.4) and 65.3% (95% CI, 50.4-78.3), respectively. With a median follow-up of 25.9 months, median progression-free survival was 25.4 months (95% CI, 15.7-29.0). Univariate analysis focusing on molecular screening found no significant impact of CXCR4 genotypes on responses and survivals but a deleterious impact of TP53 mutations on survival. Although there was no grade 5 toxicity, 26 patients were removed from the study because of side effects; the most frequent were neutropenia (9.4%), diarrhea (8.6%), and liver toxicity (9.3%). The combination of idelalisib + obinutuzumab is effective in R/R WM. Nonetheless, the apparent lack of impact of genotype on outcome could give new meaning to targeting of the phosphatidylinositol 3-kinase pathway in WM. This trial was registered at www.clinicaltrials.gov as #NCT02962401.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CHU Lille

Collections :

• Cancer Heterogeneity, Plasticity and Resistance to Therapies (CANTHER) - UMR 9020 - UMR 1277
• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Submission date :

2023-11-15T06:43:58Z
2024-02-08T12:31:28Z
2024-02-27T15:17:10Z