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DRUG:

Synribo (omacetaxine mepesuccinate)

i
Other names: sHHT, CGX-635, CXS-635, HHT, NCI 141633, C41443
Company:
ArchiMed, Teva
Drug class:
Apoptosis stimulant, MCL1 inhibitor, MYC inhibitor, Protein synthesis inhibitor, G1-S-specific cyclin-D1 inhibitor
Related drugs:
5d
New P2 trial
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Venclexta (venetoclax) • azacitidine • Synribo (omacetaxine mepesuccinate)
6d
Efficacy and Safety of Lisafotoclax Plus Decitabine and Homoharringtonine in Venetoclax/Azacitidine Pretreated AML Patients (clinicaltrials.gov)
P2, N=35, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
New P2 trial
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FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1)
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FLT3-ITD mutation • NPM1 mutation
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Venclexta (venetoclax) • azacitidine • decitabine • Synribo (omacetaxine mepesuccinate)
21d
Observation of the Therapeutic Effect of Venetoclax Combined with HEA Regimen on Acute Myeloid Leukemia Patients with KMT2A Gene Rearrangement (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi)
The VHEA regimen can significantly improve the CR rate of AML patients with KMT2A gene rearrangement, with good safety. It may be a better choice for induction remission chemotherapy in newly diagnosed and relapsed/refractory AML patients with KMT2A gene rearrangement.
Journal
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KMT2A (Lysine Methyltransferase 2A)
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Venclexta (venetoclax) • cytarabine • etoposide IV • Synribo (omacetaxine mepesuccinate)
22d
Trial completion
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Venclexta (venetoclax) • Synribo (omacetaxine mepesuccinate)
22d
Efficacy and safety of venetoclax-cytarabine-homoharringtonine-based cytoreductive therapy before allogeneic hematopoietic stem cell transplantation in refractory/relapsed acute myeloid leukemia with RUNX1::RUNX1T1: a retrospective study (PubMed, Zhonghua Xue Ye Xue Za Zhi)
All patients remained disease-free, with no events of measurable residual disease (MRD) positivity by flow cytometry or molecular analysis documented. These findings preliminarily confirm that venetoclax, cytarabine, and homoharringtonine-based cytoreductive therapy is a safe and effective bridging therapy for allo-HSCT in patients with refractory/relapsed AML and RUNX1::RUNX1T1 fusion gene.
Retrospective data • Journal
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RUNX1 (RUNX Family Transcription Factor 1) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1)
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RUNX1-RUNX1T1 fusion
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Venclexta (venetoclax) • cytarabine • Synribo (omacetaxine mepesuccinate)
25d
Homoharringtonine inhibits growth and migration in non-small cell lung cancer via PDIA4-mediated modulation of autophagy and EMT. (PubMed, Arch Pharm Res)
Additionally, HHT inhibits NSCLC migration by modulating epithelial-mesenchymal transition (EMT) signaling. These findings highlight PDIA4 as a critical mediator of HHT efficacy against NSCLC, provide novel insights into PDIA4-associated therapy, and support the translational potential of HHT in NSCLC treatment.
Journal
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PDIA4 (Protein Disulfide Isomerase Family A Member 4)
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Synribo (omacetaxine mepesuccinate)
25d
VAH vs VA in Newly Diagnosed Elderly AML (clinicaltrials.gov)
P3, N=308, Not yet recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
New P3 trial
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Venclexta (venetoclax) • azacitidine • Synribo (omacetaxine mepesuccinate)
1m
Homoharringtonine and Gilteritinib Synergistically Induce Apoptosis and Suppress Viability in FLT3-ITD-Positive AML Cells. (PubMed, Biomedicines)
The combination enhanced the p53 expression. Our findings elucidate the mechanism underlying this synergistic interaction and underscore the potential of p53 status as a predictive biomarker for identifying patients most likely to benefit from HHT and gilteritinib combination therapy.
Journal
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FLT3 (Fms-related tyrosine kinase 3) • HSPA8 (Heat Shock Protein Family A (Hsp70) Member 8)
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TP53 mutation • FLT3-ITD mutation • TP53 wild-type
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Xospata (gilteritinib) • Synribo (omacetaxine mepesuccinate)
2ms
A conserved eIF1A+ luminal cell-centered hypoxic and "cold" tumor microenvironment promotes pan-subtype prostate cancer progression. (PubMed, Cell Rep Med)
In luminal cells, EIF1A knockdown and the translation inhibitor homoharringtonine (HHT) both suppress HIF-1α translation and tumor growth, while promoting infiltration of anticancer immune cells including PD-1- T cells and CD163- macrophages...Collectively, this work defines conserved molecular features across PCa subtypes, providing promising insights for clinical management. This study was registered at Clinicaltrials.gov (NCT06834321).
Journal
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PD-1 (Programmed cell death 1) • HIF1A (Hypoxia inducible factor 1, alpha subunit) • CD163 (CD163 Molecule) • EIF1AX (Eukaryotic Translation Initiation Factor 1A X-Linked)
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Synribo (omacetaxine mepesuccinate)
2ms
Clinical efficacy analysis of seven pediatric patients with Acute myeloid leukemia and the t(16;21)(p11;q22) FUS::ERG fusion gene (PubMed, Zhonghua Yi Xue Yi Chuan Xue Za Zhi)
The t(16;21)(p11;q22) FUS::ERG fusion gene is rare in pediatric AML and associated with poor prognosis. Allo-HSCT may mitigate the adverse prognostic impact of the FUS::ERG fusion gene and contribute to prolonged survival.
Retrospective data • Journal • IO biomarker
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KIT (KIT proto-oncogene, receptor tyrosine kinase) • CD38 (CD38 Molecule) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD33 (CD33 Molecule) • CD34 (CD34 molecule) • ERG (ETS Transcription Factor ERG) • NCAM1 (Neural cell adhesion molecule 1) • FUS (FUS RNA Binding Protein) • ITGAM (Integrin, alpha M) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • ANPEP (Alanyl Aminopeptidase, Membrane)
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cytarabine • etoposide IV • daunorubicin • Synribo (omacetaxine mepesuccinate)
2ms
Cladribine Plus Homoharringtonine and Cytarabine Regimen (CHA) for de Novo Acute Myeloid Leukemia (clinicaltrials.gov)
P2, N=65, Completed, First Affiliated Hospital of Zhejiang University | Recruiting --> Completed | N=30 --> 65 | Trial primary completion date: Aug 2025 --> Apr 2025
Trial completion • Enrollment change • Trial primary completion date
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cytarabine • cladribine • Synribo (omacetaxine mepesuccinate)
2ms
Efficacy and safety of sequential therapy with Venetoclax, Azacitidine, and Homoharringtonine in elderly patients with de novo AML: A prospective, single-arm, multicenter, exploratory clinical trial (ChiCTR2500112019)
P=N/A, N=40, Not yet recruiting, the First Affiliated Hospital, Zhejiang University School of Medicine; The People's Hospital Affiliated to Ningbo University
New trial
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Venclexta (venetoclax) • azacitidine • Synribo (omacetaxine mepesuccinate)