Title |
Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data
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Published in |
Advances in Therapy, November 2016
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DOI | 10.1007/s12325-016-0447-x |
Pubmed ID | |
Authors |
Arie Barlev, Vincent W. Lin, Aaron Katz, Kuolung Hu, Ze Cong, Beth Barber |
Abstract |
Blinatumomab is a bispecific T cell-engaging antibody construct indicated for adult patients with relapsed/refractory (R/R) Ph(-) B-precursor acute lymphoblastic leukemia (ALL), an aggressive disease with poor prognosis. A phase 2 single-arm clinical study showed that 43% of patients achieved CR/CRh within two cycles and approximately 20% of patients receiving blinatumomab were still alive after 2 years. The objective of the current analysis was to estimate long-term survival of patients receiving blinatumomab beyond the observed time period in the clinical study using a large historical observational dataset. Conditional survival probabilities of blinatumomab-treated patients beyond month 60 were assumed to be the same as the US general population. At month 60, the estimated proportion of blinatumomab-treated patients alive was more than double that of historical patients (12.6% vs 5.4%). The mean overall survival was 76.1 months for blinatumomab patients and 39.8 months for historical patients. Sensitivity analyses including additional follow-up data from the clinical study showed consistent results. These findings suggest that blinatumomab provides substantial overall survival benefit to patients with (R/R) Ph(-) B-precursor ALL compared with salvage chemotherapy. Amgen. ClinicalTrials.gov identifier NCT01466179 and NCT02003612. |
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Geographical breakdown
Country | Count | As % |
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Unknown | 40 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 8 | 20% |
Other | 6 | 15% |
Student > Ph. D. Student | 6 | 15% |
Student > Master | 5 | 13% |
Student > Bachelor | 2 | 5% |
Other | 7 | 18% |
Unknown | 6 | 15% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 24 | 60% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 5% |
Biochemistry, Genetics and Molecular Biology | 2 | 5% |
Agricultural and Biological Sciences | 2 | 5% |
Unspecified | 1 | 3% |
Other | 3 | 8% |
Unknown | 6 | 15% |