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Blinatumomab delays the deterioration of health-related quality of life in patients with B-cell precursor acute lymphoblastic leukemia

The quality of life analysis of the phase III TOWER study, assessing blinatumomab in patients with Philadelphia chromosome-negative (Ph–) relapsed/refractory (r/r) B-cell precursor acute lymphoblastic leukemia (BCP-ALL), demonstrated that, compared to standard of care chemotherapy, blinatumomab delayed the time to clinically meaningful deterioration in the health-related quality of life (HRQoL) across almost all functional domains and symptoms relevant to oncologic patients. Moreover, the HRQoL benefits with blinatumomab relative to chemotherapy could be observed as early as 8 days after the start of the treatment. These data on quality of life combined with the previously reported improvements in overall survival (OS) with blinatumomab underline the favorable benefit to risk profile of blinatumomab in this setting.

Blinatumomab is a bispecific T-cell engager antibody construct that specifically binds CD19 (B cells) and CD3 (T cells). In doing so, blinatumomab facilitates lysis of CD19-positive B- cells. Based on a single-arm phase 2 study, blinatumomab was approved for the Ph- r/r BCP-ALL. Previously, data of the phase 3, randomized, open-label TOWER study (N=405), demonstrated a significant OS benefit with blinatumomab as compared to standard of care chemotherapy in adult patients with Ph– r/r BCP-ALL. During ASH 2016 the HRQoL data of the TOWER study were presented.

In the TOWER study, patients were randomized 2:1 to receive either blinatumomab (N=271) or standard of care chemotherapy (N=134). Patients in remission after 2 induction cycles were eligible to continue therapy. A 12-month maintenance phase was allowed for patients who received up to 3 consolidation cycles and continued with a bone marrow response. For this analysis, the HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) on day 1 (baseline), day 8, day 15 and day 29 in each cycle of investigational therapy and safety follow up. Time-to-deterioration (TTD) analyses were conducted to determine the treatment effect based on timing from the initiation of treatment to a 10-point deterioration from baseline in HRQoL using EORTC QLQ-C30 or time to an event free survival (EFS) event.

Of the 376 patients who received at least 1 dose of study drug, 342 patients had baseline and more than one post-baseline HRQoL results. Overall, the mean pre-treatment baseline scores were well balanced between the blinatumomab and the chemotherapy groups. In general, patients receiving blinatumomab had better post-treatment HRQoL as compared to chemotherapy across all multi-item scales or single-item measures based on visual inspection. With chemotherapy, worsening in HRQoL was seen in almost all investigated topics as early as day 8 of the first cycle. With blinatumomab however, the mean changes from baseline suggested an improvement in the HRQoL in almost all subscales. The hazard ratios (HRs) for the time to deterioration analyses ranged from 0.588 to 0.798 in favor of blinatumomab, with the upper bounds to the 95% confidence interval below 1.0 for all subscales and single items except insomnia.

In summary, compared to chemotherapy, blinatumomab delayed the time to clinically meaningful deterioration in HRQoL across almost all functional domains and symptoms relevant to oncology patients. Moreover, HRQoL benefits with blinatumomab relative to SOC could be observed as early as 8 days after treatment initiation.

Reference

Topp M, Zimmerman Z, Cannell P, et al. Health-Related Quality of Life (HRQoL) of Blinatumomab Versus Standard of Care (SOC) Chemotherapy in Patients with Relaspsed or Refractory Philadelphia Negative B-Cell Precursor Acute Lymphoblastic Leukemia in a Randomized, Open-Label Phase 3 Study (TOWER). Presented at ASH 2016, Abstract 222.

Speaker Max Topp

Topp

Max Topp, MD,
Universitätsklinikums Würzburg, Würzburg, Germany

 

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