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The treatment landscape for patients with Philadelphia chromosome negative (Ph−) acute lymphoblastic leukemia (ALL) has expanded with the introduction of targeted therapies; therefore, combining these agents with chemotherapy is a key treatment of interest. Below, we summarize three key presentations on novel therapies for the treatment of Ph− ALL, presented at the European Hematology Association (EHA) 2023 Congress.
Haddad presented overall survival (OS) and relapse-free survival (RFS) data for venetoclax in combination with mini-hyper-cyclophosphamide, vincristine, and dexamethasone (CVD) in relapsed/refractory (R/R) Ph− ALL, and a study of inotuzumab ozogamicin (InO) with or without blinatumomab in older patients with newly diagnosed Ph- ALL1,2; Short presented response rates of hyper-CVAD (cyclophosphamide, vincristine doxorubicin, and dexamethasone) with blinatumomab and InO in de novo Ph− ALL.3
This open-label, phase II trial (NCT03808610) investigated the combination of venetoclax with low intensity mini-hyper-CVD in patients with R/R Ph− B-cell or T-cell ALL (B-ALL; T-ALL). The study endpoints included RFS and OS, other endpoints included complete response (CR), overall response rate (ORR), and median time to platelet and neutrophil recovery.
Mini-hyper CVD in combination with venetoclax was effective with a favorable safety profile in patients with R/R Ph− B-cell or T-cell ALL.
Haddad presented another open-label, phase II trial (NCT01371630) investigating InO plus mini-hyper-CVD in combination with blinatumomab in newly diagnosed patients aged ≥60 years with Ph− pre-B ALL. The study endpoints were the duration of complete remission and OS. Other endpoints included CR, ORR, and minimal residual disease (MRD) negativity rate.1
Mini-hyper-CVD plus InO plus blinatumomab was effective with a tolerable safety profile in this subgroup of older patients with newly diagnosed Ph− ALL.1 Patients aged 60–69 years without poor-risk cytogenetics and had significantly improved 5-year OS (72%).
Short presented an open-label, phase II study (NCT02877303) examining the efficacy and safety of hyper-CVAD in combination with sequential blinatumomab with or without InO in patients with newly diagnosed Ph− B-cell ALL. The study endpoints were CR, RFS, and OS. Other endpoints included flow MRD negativity rate and 30-day mortality.
Figure 1. Response rates*
CR, complete response; blina, blinatumomab; HCVAD, hyper-cyclophosphamide, vincristine doxorubicin, and dexamethasone; InO, inotuzumab ozogamicin; MRD, minimal residual disease.
Data from Short.3
Hyper-CVAD combined with sequential blinatumomab ± InO is an effective first-line therapy for patients with newly diagnosed Ph− B-cell ALL.3 The addition of InO improves response and safety outcomes compared with blinatumomab alone.
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