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    DRUG:

    Nailike (olverembatinib)

    i
    Other names: HQP1351, APG-1351, APG 1351, HQP1351, GZD824, D824, IBI-348, APG1351, D 824, GZD 824, HQP 1351, IBI 348, D-824, GZD-824, HQP-1351, IBI348
    Company:
    Ascentage Pharma, Innovent Biologics, Takeda
    Drug class:
    Bcr-abl inhibitor
    Related drugs:
    13d
    Chronic myeloid leukemia: incorporation of recent advances into current treatment algorithms. (PubMed, Blood Cancer J)
    In patients experiencing failure of frontline therapy due to resistance or intolerance, multiple second- and third-line options are available, including second-generation TKIs, ponatinib, and asciminib, as well as novel investigational agents, including the ABL1 kinase domain inhibitors olverembatinib and ELVN-001 and the STAMP inhibitors TGRX-678 and TERN-701. In this review, we discuss the recent advances in the treatment of CML-CP and challenge some established management practices.
    Review • Journal
    |
    ABL1 (ABL proto-oncogene 1)
    |
    Iclusig (ponatinib) • Scemblix (asciminib) • Nailike (olverembatinib) • TGRX-678 • ELVN-001 • TERN-701
    20d
    Olverembatinib, a novel BCR-ABL tyrosine kinase inhibitor, exhibits anti-tumor activity and synergizes with gemcitabine in pancreatic ductal adenocarcinoma. (PubMed, NPJ Precis Oncol)
    Clinically, olverembatinib exhibited promising efficacy in patients with advanced PDAC who had failed multiple prior lines of therapies, including gemcitabine-based treatment. These findings suggest that olverembatinib, either as monotherapy or in combination with gemcitabine, represents a promising novel therapeutic strategy for the treatment of PDAC.
    Journal
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • JAK1 (Janus Kinase 1) • STAT1 (Signal Transducer And Activator Of Transcription 1)
    |
    gemcitabine • Nailike (olverembatinib)
    28d
    ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL (clinicaltrials.gov)
    P=N/A, N=92, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting --> Recruiting | N=30 --> 92
    Enrollment open • Enrollment change • IO biomarker
    |
    ABL2 (ABL Proto-Oncogene 2, Non-Receptor Tyrosine Kinase)
    |
    Venclexta (venetoclax) • cytarabine • Jakafi (ruxolitinib) • cyclophosphamide • Blincyto (blinatumomab) • Nailike (olverembatinib) • fludarabine IV
    28d
    Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL (clinicaltrials.gov)
    P=N/A, N=110, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    ABL1 (ABL proto-oncogene 1) • BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • cytarabine • Blincyto (blinatumomab) • Nailike (olverembatinib)
    1m
    A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1) (clinicaltrials.gov)
    P3, N=350, Recruiting, Ascentage Pharma Group Inc. | N=71 --> 350 | Trial completion date: Oct 2028 --> Jun 2029 | Trial primary completion date: Dec 2024 --> Dec 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Nailike (olverembatinib)
    1m
    APG2575AC101: Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML (clinicaltrials.gov)
    P1/2, N=682, Recruiting, Ascentage Pharma Group Inc. | N=458 --> 682
    Enrollment change
    |
    azacitidine • Nailike (olverembatinib) • lisaftoclax (APG-2575) • Synribo (omacetaxine mepesuccinate)
    2ms
    SJ-0003: A Study of HQP1351 in Patients With GIST or Other Solid Tumors (clinicaltrials.gov)
    P1, N=100, Recruiting, Ascentage Pharma Group Inc. | Trial completion date: Dec 2026 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    NF1 (Neurofibromin 1) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B)
    |
    Nailike (olverembatinib)
    3ms
    Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL (clinicaltrials.gov)
    P=N/A, N=100, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New trial • IO biomarker
    |
    ABL1 (ABL proto-oncogene 1) • BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • cytarabine • Blincyto (blinatumomab) • Nailike (olverembatinib)
    3ms
    Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, M.D. Anderson Cancer Center | Trial completion date: Sep 2031 --> Sep 2033 | Initiation date: Feb 2026 --> Aug 2026 | Trial primary completion date: Sep 2026 --> Sep 2031
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1)
    |
    Nailike (olverembatinib)
    3ms
    ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL (clinicaltrials.gov)
    P=N/A, N=30, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New trial • IO biomarker
    |
    ABL2 (ABL Proto-Oncogene 2, Non-Receptor Tyrosine Kinase)
    |
    Venclexta (venetoclax) • cytarabine • Jakafi (ruxolitinib) • cyclophosphamide • Blincyto (blinatumomab) • Nailike (olverembatinib) • fludarabine IV
    3ms
    Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Therapy Followed by HSCT in Ph+ ALL (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P2 trial
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
    |
    Besponsa (inotuzumab ozogamicin) • Nailike (olverembatinib)
    4ms
    Olverembatinib and high-dose methotrexate in acute lymphoblastic leukemia: delayed methotrexate clearance and increased nephrotoxicity. (PubMed, Leuk Lymphoma)
    Flumatinib likewise lowered MTX clearance and raised ≥ grade 2 nephrotoxicity to 29.4%, yet neither effect reached statistical significance. Temporary withdrawal of olverembatinib before HD-MTX infusion may prevent MTX-related nephrotoxicity.
    Journal
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    methotrexate • Nailike (olverembatinib) • Hansoh Xinfu (flumatinib) • methotrexate IV