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DRUG:

Astarabine (asparagine cytarabine conjugate)

i
Other names: BSR-236, BST-236
Company:
Ayala Pharma
Drug class:
DNA synthesis inhibitor
Related drugs:
8ms
BST-236 as a Single Agent in Adults With Relapsed or Refractory AML or HR-MDS (clinicaltrials.gov)
P2, N=40, Active, not recruiting, Groupe Francophone des Myelodysplasies | Recruiting --> Active, not recruiting
Enrollment closed
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Astarabine (asparagine cytarabine conjugate)
1year
Frontline Aspacytarabine with Venetoclax for Older/Unfit Patients with Acute Myeloid Leukemia: Preliminary Results of a Phase 1 Study (ASH 2023)
The combination induction regimen of ASPA and VEN followed by consolidation with ASPA alone, is a promising therapy. The regimen is tolerable, and all patients in cohort 2 have attained a CR with 2/3 MRDneg and the third with treatment ongoing. This treatment may overcome the limitations of prolonged cytopenia and indefinite therapy with HMA/VEN along with a high CR rate.
Clinical • P1 data
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Venclexta (venetoclax) • Astarabine (asparagine cytarabine conjugate)
1year
Aspacytarabine for the treatment of patients with AML unfit for intensive chemotherapy: a phase 2 study. (PubMed, Blood Adv)
Adverse events typically precluding the use of high-dose cytarabine in older or unfit patients were not observed. Aspacytarabine appears to be an effective regimen, with a reduction in the attendant toxicities associated with high-dose cytarabine, an important consideration when treating AML and other hematologic disorders that use high-dose cytarabine.
P2 data • Journal
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TP53 (Tumor protein P53)
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TP53 mutation
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Astarabine (asparagine cytarabine conjugate)
4years
[VIRTUAL] Durable Remissions and Increased Overall Survival in AML Patients Deemed Unfit for Standard Intensive Chemotherapy Achieved with High-Dose BST-236 (Aspacytarabine) Induction and Consolidation (ASH 2020)
Introduction: BST-236 (aspacytarabine), a novel pyrimidine antagonist, is a cytarabine prodrug designed to deliver high cytarabine doses with reduced systemic toxicity. Conclusions : The cumulative clinical data suggest that BST-236 as a single agent treatment is a safe and efficacious induction and consolidation therapy for patients who are unfit for standard intensive chemotherapy, including patients with adverse cytogenetics and prior exposure to HMA. The data may establish BST-236 as a new intensive therapy backbone of AML and may, for the first time, allow older adults deemed unfit for standard intensive induction and consolidation therapy, to benefit from an intensive treatment.
Clinical
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TP53 (Tumor protein P53)
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TP53 mutation
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cytarabine • Astarabine (asparagine cytarabine conjugate)