Key clinical point: Addition of oblimersen sodium (G3139) to standard chemotherapy did not improve clinical outcomes vs standard chemotherapy alone in previously untreated older patients with acute myeloid leukemia (AML).
Major finding: No statistically significant differences were observed in complete remission rates ( P = .53), median overall survival (1-sided log-rank P = .13), median event-free survival ( P = .80), median disease-free survival ( P = .26), and early death rates ( P = .81) in the G3139 vs standard chemotherapy arm. No added toxicities were observed with G3139 vs standard chemotherapy alone.
Study details: Findings are from phase 3 Cancer and Leukemia Group B 10201 trial including 506 untreated patients with AML aged at least 60 years. Patients were randomly assigned to receive standard intensive cytarabine/daunorubicin induction chemotherapy and high-dose cytarabine consolidation with (n=254) or without (n=252) G3139.
Disclosures: This work was supported by the National Cancer Institute, National Institutes of Health, and Deltec Inc. Some investigators including the lead author reported ties with various pharmaceutical companies.
Source: Walker AR et al. Blood Adv. 2021 Jul 12. doi: 10.1182/bloodadvances.2021004233 .