Blinatumomab treatment of older adults with relapsed/refractory B-precursor acute lymphoblastic leukemia: Results from 2 phase 2 studies.

Abstract

BACKGROUND:

Older adults with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL) are reported to have a poor prognosis and few therapeutic options. In the current study, the authors evaluated treatment with single-agent blinatumomab in adults aged ≥65 years with r/r ALL.

METHODS:

A total of 261 adults with r/r ALL who were examined across two phase 2 studies received blinatumomab in cycles of 4-week continuous infusion and 2-week treatment-free intervals. The primary endpoint in each study was complete remission (CR) or CR with partial hematologic recovery (CRh) during the first 2 cycles. Data were pooled and analyzed according to patient age at screening (aged ≥65 years vs aged <65 years).

RESULTS:

Of 36 older adults, 56% (95% confidence interval [95% CI], 38%-72%) achieved CR/CRh during the first 2 cycles compared with 46% (225 patients) (95% CI, 40%-53%) of younger adults. Complete minimal residual disease responses were 60% in older and 70% in younger responders. Three older responders (15%) and 61 younger responders (59%) proceeded to allogeneic hematopoietic stem cell transplantation. Kaplan-Meier curves overlapped for relapse-free and overall survival for both age groups. Older adults were found to have a similar incidence of grade ≥3 adverse events (AEs) as younger adults (86% vs 80%) but more grade ≥3 neurologic events (28% vs 13%). Cytokine release syndrome occurred in 7 older (19%) (1 case of grade 3) and 23 younger (10%) (4 cases of grade ≥3) adults. There were no treatment-related fatal AEs reported.

CONCLUSIONS:

Older adults with r/r ALL who were treated with single-agent blinatumomab were found to have similar hematologic response rates and incidence of grade ≥3 AEs compared with younger adults but had more neurologic events, which were reversible and primarily resolved with treatment interruption. Cancer 2016;122:2178-85. © 2016 American Cancer Society.

• Authors: Hagop M Kantarjian, Anthony S Stein, Ralf C Bargou, Carlos Grande Garcia, Richard A Larson, Matthias Stelljes, Nicola Gökbuget, Gerhard Zugmaier, Jonathan E Benjamin, Alicia Zhang, Catherine Jia, Max S Topp
• Journal: Cancer (Cancer) Vol. 122 Issue 14 Pg. 2178-85 (07 15 2016) ISSN: 1097-0142 [Electronic] United States
• PMID: 27143254 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2016 American Cancer Society.

Chemical References

• Antibodies, Bispecific
• Antineoplastic Agents
• blinatumomab

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antibodies, Bispecific (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• Clinical Trials, Phase II as Topic
• Drug Resistance, Neoplasm
• Female
• Hematopoietic Stem Cell Transplantation
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Molecular Targeted Therapy
• Multicenter Studies as Topic
• Precursor B-Cell Lymphoblastic Leukemia-Lymphoma (drug therapy, mortality, pathology)
• Recurrence
• Retreatment
• Transplantation, Homologous
• Treatment Outcome
• Young Adult