High tumor burden before blinatumomab has a negative impact on the outcome of adult patients with B-cell precursor acute lymphoblastic leukemia. A real-world study by the GRAALL

Cabannes‐Hamy, Aurélie; Brissot, Éolia; Leguay, Thibaut; Huguet, Françoise; Chevallier, Patrice; Hunault, Mathilde; Escoffre‐Barbe, Martine; Cluzeau, Thomas; Balsat, Marie; Nguyen, Stéphanie; Pasquier, Florence; Alexis, Magda; Lhéritier, Véronique; Pastoret, Cédric; Delabesse, Éric; Clappier, Emmanuelle; Dombret, Hervé; Boissel, Nicolas

doi:10.3324/haematol.2021.280078

Cited by 14 publications

(13 citation statements)

References 25 publications

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“…These promising results suggest that CT does not impair the immune-mediated efficacity of blinatumomab, and that the efficacy of associating CT and blinatumomab may be cumulative. This is line with recent real-world data showing that low tumour burden and debulking therapy are associated with better outcome in patients treated with blinatumomab, 13,14 which highlights the known importance of effector-to-target ratio for the efficacy of bispecific T-cell engager. 15 At this point it is unclear whether less intensive CT than VANDA could be used in association with blinatumomab with the same efficacy.…”

Section: Discussionsupporting

confidence: 89%

VANDA regimen followed by blinatumomab leads to favourable outcome in patients with Philadelphia chromosome‐negative B‐precursor acute lymphoblastic leukaemia in first relapse

Heraudet¹,

Galtier²,

Favre³

et al. 2022

Br J Haematol

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Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (R/R BCP-ALL) have a dismal prognosis. 1 Intensive chemotherapy (CT) leads to complete remission (CR) in fewer than 40% of patients and there is no standard schedule. 2 Long-term overall survival (OS) rates are under 20% at 5 years, but prolonged OS is possible for the small subset of patients achieving a CR and proceeding to allogeneic stem cell transplantation (HSCT). 2 Blinatumomab, a CD19/CD3 bispecific T cell engager, has shown its superiority over CT for R/R BCP-ALL and is a valuable option as a bridge to transplantation. 3 Sequential addition of blinatumomab improves outcome for patients in CR with positive measurable residual disease (MRD) after CT, in first line as well as in R/R settings. 4,5 However, concomitant administration of CT and blinatumomab in R/R BCP-ALL to increase the complete response rate has not been explored. The VANDA regimen (etoposide, high-dose cytarabine, mitoxantrone, dexamethasone, asparaginase), an intensive paediatric CT, is used for patients with R/R BCP-ALL before HSCT. Here, we report the outcome of 17 Philadelphia chromosome-negative (Ph−) patients in first relapse BCP-ALL consecutively treated with combination of VANDA and blinatumomab (VANDA-BLI regimen). PATIE N TS A N D ST U DY PROTOCOLThis analysis was conducted at the Bordeaux University Hospital (France). All adult patients (>18 years) with Ph− R/R BCP-ALL diagnosed between January 2016 and June 2021 and considered eligible for intensive CT by clinicians (regarding age and comorbidities) were consecutively treated with VANDA-BLI, and included in this report. All patients received an anthracycline-containing regimen at first line, including a paediatric or paediatric-inspired protocols in 15 patients. According to French law on ethics, patients were

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Section: Discussionsupporting

confidence: 89%

VANDA regimen followed by blinatumomab leads to favourable outcome in patients with Philadelphia chromosome‐negative B‐precursor acute lymphoblastic leukaemia in first relapse

Heraudet¹,

Galtier²,

Favre³

et al. 2022

Br J Haematol

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“…The NEUF study describes the largest documented European cohort of patients treated with blinatumomab in real-world clinical practice reported to date. The real-world effectiveness of blinatumomab in adults with MRD+ or R/R ALL was comparable to that reported in other clinical and real-world studies [2,3,6,[9][10][11][12][13][14][15].…”

Section: Discussionsupporting

confidence: 81%

“…In the Phase 2 clinical trial, 78% of patients achieved a complete MRD response [3]. In the FRENCH-CYTO study, 89% of the MRD+ patients achieved a complete MRD response following blinatumomab [13]. Crucially, the NEUF study shows that survival outcomes were improved in patients who did versus did not have an MRD response, and in patients in the CR1 versus CR2+ subgroup, in line with earlier findings from the Phase 2 trial [6].…”

Section: Discussionsupporting

confidence: 72%

“…Moreover, given the good results when censoring for HSCT, blinatumomab could be considered to be a valuable option also for older patients unfit for transplantation. Despite some differences in patient characteristics and outcomes, the data of the NEUF study align overall with the literature [13][14][15].…”

Section: Discussionsupporting

confidence: 58%

“…Evidence of real-world use of blinatumomab to date is based on data from a compassionate use program in France, an ad hoc survey in Italy, and a retrospective cohort study in the USA [13][14][15]. These data sets demonstrated responses comparable to those reported in clinical trials [2,9].…”

Section: Introductionmentioning

confidence: 99%

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Real-world use of blinatumomab in adult patients with B-cell acute lymphoblastic leukemia in clinical practice: results from the NEUF study

Boissel¹,

Chiaretti

Papayannidis³

et al. 2023

Blood Cancer J.

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This retrospective observational study (NEUF) included adult patients with B-cell acute lymphoblastic leukemia (B-cell ALL) who had received blinatumomab for the treatment of minimal residual disease-positive (MRD+) or relapsed/refractory (R/R) B-cell ALL via an expanded access program (EAP). Patients were eligible if blinatumomab was initiated via the EAP between January 2014 and June 2017. Patients were followed from blinatumomab initiation until death, entry into a clinical trial, the end of follow-up, or the end of the study period (December 31, 2017), whichever occurred first. Of the 249 adult patients included, 109 were MRD+ (83 Philadelphia chromosome-negative [Ph−] and 26 Philadelphia chromosome-positive [Ph+]) and 140 had a diagnosis of R/R B-cell ALL (106 Ph− and 34 Ph+). In the MRD+ group, within the first cycle of blinatumomab treatment, 93% (n = 49/53) of Ph− and 64% (n = 7/11) of Ph+ patients with evaluable MRD achieved an MRD response (MRD <0.01%). Median overall survival (OS) was not reached over a median follow-up time of 18.5 months (Ph−, 18.8 [range: 5.1–34.8] months; Ph+, 16.5 [range: 1.8–31.6] months). In the R/R group, within two cycles of blinatumomab, 51% of Ph− and 41% of Ph+ patients achieved complete hematologic remission (CR/CRh/CRi), and 83% of Ph− and 67% of Ph+ MRD-evaluable patients in CR/CRh/CRi achieved an MRD response. Median (95% confidence interval) OS was 12.2 (7.3–24.2) months in the R/R Ph− subgroup and 16.3 (5.3–not estimated) months in the R/R Ph+ subgroup. This large, real-world data set of adults with B-cell ALL treated with blinatumomab confirms efficacy outcomes from published studies.

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Low leukemia burden improves blinatumomab efficacy in patients with relapsed/refractory B‐cell acute lymphoblastic leukemia

Queudeville

Stein

Locatelli

et al. 2023

Cancer

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Background A lower baseline bone marrow blast percentage (bBMB%) is associated with better outcomes in patients with B‐cell acute lymphoblastic leukemia (B‐ALL) receiving blinatumomab. The objective of this analysis was to investigate the association between bBMB% and treatment outcomes in relapsed/refractory (R/R) B‐ALL. Methods Data from five trials of blinatumomab for R/R B‐ALL were pooled for analyses. Patients were placed in one of three groups: group 1, ≥50% bBMBs; group 2, ≥25% to <50% bBMBs; group 3, ≥5% to <25% bBMBs. Response and survival outcomes were compared between groups. Results Data from 683 patients (166 pediatric, 517 adult) were analyzed. Collectively, patients in groups 2 and 3 had significantly higher odds of achieving a complete remission (CR) (odds ratio [OR], 3.50 [95% confidence interval (CI), 2.23–5.48] and 3.93 [95% CI, 2.50–6.18], respectively; p < .001) and minimal/measurable residual disease response (OR, 2.61 and 3.37, respectively; p < .001) when compared with group 1 (reference). Groups 2 and 3 had a 37% and 46% reduction in the risk of death (hazard ratio [HR], 0.63 and 0.54, respectively; p < .001) and a 41% and 43% reduction in the risk of an event (relapse or death) (HR, 0.59 and 0.57, respectively; p < .001) compared with group 1. No significant differences in response or survival outcomes were observed between groups 2 and 3. Seven of nine patients whose bBMB% was lowered to <50% with dexamethasone achieved CR with blinatumomab. Conclusion Any bBMB% <50% was associated with improved efficacy following blinatumomab treatment for R/R B‐ALL.

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High tumor burden before blinatumomab has a negative impact on the outcome of adult patients with B-cell precursor acute lymphoblastic leukemia. A real-world study by the GRAALL

Cited by 14 publications

References 25 publications

VANDA regimen followed by blinatumomab leads to favourable outcome in patients with Philadelphia chromosome‐negative B‐precursor acute lymphoblastic leukaemia in first relapse

VANDA regimen followed by blinatumomab leads to favourable outcome in patients with Philadelphia chromosome‐negative B‐precursor acute lymphoblastic leukaemia in first relapse

Real-world use of blinatumomab in adult patients with B-cell acute lymphoblastic leukemia in clinical practice: results from the NEUF study

Low leukemia burden improves blinatumomab efficacy in patients with relapsed/refractory B‐cell acute lymphoblastic leukemia

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