- In patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R BCP ALL), inotuzumab ozogamicin (InO) delivered superior rates of complete remission (CR)/CR with incomplete hematological recovery (CRi) vs standard-of-care (SOC) intensive chemotherapy.
Why this matters
- 5-year OS in this setting is approximately 5%-10%; a significant unmet need therefore persists for an improved treatment option.
- Final report at >2 years of follow-up from the phase 3 INO-VATE study of InO (n=164) vs SOC (n=162) in 326 patients with R/R BCP ALL.
- Funding: Pfizer, Inc.
- 73.8% of patients achieved CR/CRi with InO vs 35.0% with SOC; the CR/CRi benefit with InO was consistent across all patient subgroups.
- Median OS: 7.7 (95% CI, 6.0-9.2) months with InO vs 6.2 (95% CI, 4.7-8.3) months with SOC.
- 39.6% (95% CI, 32.1%-47.6%) of patients in the InO group vs 10.5% (95% CI, 6.2%-16.3%) in the SOC group proceeded to hematopoietic stem cell transplant after achieving CR/CRi before initiating follow-up induction therapy (P<.0001>
- The most frequent all-grade and grade ≥3 adverse events were hematologic in both treatment groups.
- Limited number of patients with t(4;11) karyotype.