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    DRUG:

    Asparlas (calaspargase pegol-mknl)

    i
    Other names: SHP663, EZN-2285, SC-PEG E. coli L-asparaginase, succinimidyl carbonate monomethoxypolyethylene glycol E. coli L-asparaginase, Cal-PEG, SC-PEG2100 E. coli L-asparaginase, S95015, CalPEG, Cal PEG, EZN2285, EZN 2285, S-95015, S 95015, SHP-663, SHP 663
    Company:
    Leadiant Biosci, Servier, Takeda
    Drug class:
    Asparagine depleter, Aspartate-ammonia ligase inhibitor
    Related drugs:
    11d
    Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, St. Jude Children's Research Hospital | N=98 --> 35 | Trial completion date: Jul 2029 --> Mar 2025 | Trial primary completion date: Aug 2025 --> Jun 2024
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • dasatinib • cytarabine • cyclophosphamide • etoposide IV • Blincyto (blinatumomab) • vincristine • navitoclax (ABT 263) • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl)
    16d
    AALL1821: A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov)
    P2, N=300, Suspended, National Cancer Institute (NCI) | N=550 --> 300
    Enrollment change • Combination therapy • Checkpoint inhibition
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Opdivo (nivolumab) • cytarabine • Blincyto (blinatumomab) • methotrexate • vincristine • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Hemady (dexamethasone tablets) • ABP 206 (nivolumab biosimilar) • Asparec (PEGylated recombinant Erwinia chrysantemi-derived L-asparaginase) • Starasid (cytarabine ocfosfate) • dexamethasone injection
    18d
    CASPER: Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1, N=15, Recruiting, OHSU Knight Cancer Institute | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial primary completion date
    |
    Cotellic (cobimetinib) • Asparlas (calaspargase pegol-mknl)
    1m
    Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (clinicaltrials.gov)
    P2, N=171, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2027 --> Dec 2028 | Initiation date: Oct 2024 --> Jan 2025 | Trial primary completion date: Dec 2027 --> Dec 2028
    Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
    |
    MCL1 (Myeloid cell leukemia 1) • KMT2A (Lysine Methyltransferase 2A) • BCL2L1 (BCL2-like 1)
    |
    BCL2 expression
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate) • prednisolone
    1m
    A Study Comparing the Combination of Dasatinib and Chemotherapy Treatment With or Without Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or Philadelphia Chromosome-Like (Ph-Like) ABL-Class B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov)
    P3; Initiation date: Jul 2024 --> Feb 2025
    Trial initiation date
    |
    ABL1 (ABL proto-oncogene 1) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • CD19 (CD19 Molecule) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • CSF1R (Colony stimulating factor 1 receptor)
    |
    CD19 expression
    |
    TruSight RNA Pan-Cancer Panel
    |
    dasatinib • imatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Starasid (cytarabine ocfosfate)
    3ms
    A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy) (clinicaltrials.gov)
    P2, N=22, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    Venclexta (venetoclax) • decitabine • Asparlas (calaspargase pegol-mknl)
    3ms
    SPARK-ALL: Calaspargase Pegol in Adults With ALL (clinicaltrials.gov)
    P2/3, N=122, Recruiting, Institut de Recherches Internationales Servier | Trial primary completion date: Dec 2023 --> Feb 2027
    Trial primary completion date
    |
    Asparlas (calaspargase pegol-mknl)
    4ms
    Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma (clinicaltrials.gov)
    P2, N=128, Not yet recruiting, St. Jude Children's Research Hospital
    New P2 trial
    |
    dasatinib • cytarabine • cyclophosphamide • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • vincristine • daunorubicin • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine
    4ms
    AALL1631: Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P3; Recruiting --> Active, not recruiting
    Combination therapy • Enrollment closed • IO biomarker
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • IKZF1 (IKAROS Family Zinc Finger 1) • CSF1R (Colony stimulating factor 1 receptor)
    |
    TruSight RNA Pan-Cancer Panel
    |
    imatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Neupogen (filgrastim) • Starasid (cytarabine ocfosfate) • dexrazoxane
    5ms
    CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov)
    P1, N=20, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2027 --> May 2027 | Trial primary completion date: Nov 2024 --> May 2025
    Trial completion date • Trial primary completion date
    |
    Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Asparlas (calaspargase pegol-mknl)
    6ms
    AALL1621: Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=80, Recruiting, Children's Oncology Group | Trial completion date: Dec 2024 --> Mar 2026 | Trial primary completion date: Dec 2024 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    KMT2A (Lysine Methyltransferase 2A) • CD22 (CD22 Molecule)
    |
    cytarabine • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • leucovorin calcium • Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Starasid (cytarabine ocfosfate)
    6ms
    Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax (clinicaltrials.gov)
    P1/2, N=98, Active, not recruiting, St. Jude Children's Research Hospital | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Venclexta (venetoclax) • dasatinib • cytarabine • cyclophosphamide • etoposide IV • Blincyto (blinatumomab) • vincristine • navitoclax (ABT 263) • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl)
    6ms
    Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL) (clinicaltrials.gov)
    P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=154 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • vincristine • daunorubicin • navitoclax (ABT 263) • Oncaspar liquid (pegaspargase) • nelarabine • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
    7ms
    SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (clinicaltrials.gov)
    P2, N=240, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Jul 2025 --> Jul 2027
    Trial completion date
    |
    Asparlas (calaspargase pegol-mknl)
    7ms
    Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL) (clinicaltrials.gov)
    P2, N=145, Not yet recruiting, St. Jude Children's Research Hospital
    New P2 trial
    |
    Venclexta (venetoclax) • dasatinib • cytarabine • bortezomib • cyclophosphamide • vincristine • daunorubicin • nelarabine • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine
    7ms
    Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (clinicaltrials.gov)
    P2, N=171, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date • Combination therapy
    |
    MCL1 (Myeloid cell leukemia 1) • KMT2A (Lysine Methyltransferase 2A) • BCL2L1 (BCL2-like 1)
    |
    BCL2 expression
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate) • prednisolone
    7ms
    Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL) (clinicaltrials.gov)
    P2, N=154, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2024 --> Aug 2024
    Trial initiation date
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • vincristine • daunorubicin • navitoclax (ABT 263) • Oncaspar liquid (pegaspargase) • nelarabine • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
    7ms
    A Study Comparing the Combination of Dasatinib and Chemotherapy Treatment With or Without Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or Philadelphia Chromosome-Like (Ph-Like) ABL-Class B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov)
    P3; Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date
    |
    ABL1 (ABL proto-oncogene 1) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • CD19 (CD19 Molecule) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • CSF1R (Colony stimulating factor 1 receptor)
    |
    CD19 expression
    |
    TruSight RNA Pan-Cancer Panel
    |
    dasatinib • imatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Starasid (cytarabine ocfosfate)
    7ms
    AALL1621: Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=80, Recruiting, Children's Oncology Group | Active, not recruiting --> Recruiting
    Enrollment open
    |
    KMT2A (Lysine Methyltransferase 2A) • CD22 (CD22 Molecule)
    |
    MLL rearrangement • CD22 expression
    |
    cytarabine • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • leucovorin calcium • Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl) • Starasid (cytarabine ocfosfate)
    8ms
    A Study of SNDX-5613 in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia (clinicaltrials.gov)
    P2, N=78, Recruiting, Children's Oncology Group | Active, not recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    MLL rearrangement
    |
    cytarabine • methotrexate • vincristine • revumenib (SNDX-5613) • fludarabine IV • Asparlas (calaspargase pegol-mknl) • Starasid (cytarabine ocfosfate)
    8ms
    Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (clinicaltrials.gov)
    P2, N=171, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial • Combination therapy
    |
    MCL1 (Myeloid cell leukemia 1) • KMT2A (Lysine Methyltransferase 2A) • BCL2L1 (BCL2-like 1)
    |
    BCL2 expression
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate) • prednisolone
    8ms
    2157GCCC:Phase 1 of Calaspargase Pegol-mknl w/ Cytarabine and Idarubicin in Newly Dx AML (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, University of Maryland, Baltimore | Recruiting --> Active, not recruiting | N=24 --> 6
    Enrollment closed • Enrollment change • Combination therapy
    |
    MCL1 (Myeloid cell leukemia 1) • BCL2L1 (BCL2-like 1)
    |
    BCL2 expression
    |
    cytarabine • idarubicin hydrochloride • Asparlas (calaspargase pegol-mknl)
    8ms
    A Study Comparing the Combination of Dasatinib and Chemotherapy Treatment With or Without Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or Philadelphia Chromosome-Like (Ph-Like) ABL-Class B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov)
    P3; Initiation date: Jan 2024 --> Apr 2024
    Trial initiation date
    |
    ABL1 (ABL proto-oncogene 1) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • CD19 (CD19 Molecule) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • CSF1R (Colony stimulating factor 1 receptor)
    |
    CD19 expression
    |
    TruSight RNA Pan-Cancer Panel
    |
    dasatinib • imatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Starasid (cytarabine ocfosfate)
    9ms
    Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax (clinicaltrials.gov)
    P1/2, N=90, Recruiting, St. Jude Children's Research Hospital | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial primary completion date
    |
    Venclexta (venetoclax) • dasatinib • cytarabine • cyclophosphamide • etoposide IV • Blincyto (blinatumomab) • vincristine • navitoclax (ABT 263) • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl)
    9ms
    AALL1732: Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy (clinicaltrials.gov)
    P3, N=4997, Recruiting, Children's Oncology Group | Trial completion date: Jun 2029 --> Mar 2030 | Trial primary completion date: Jun 2029 --> Mar 2030
    Trial completion date • Trial primary completion date
    |
    cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
    9ms
    A Study of SNDX-5613 in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia (clinicaltrials.gov)
    P2, N=78, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    MLL rearrangement
    |
    cytarabine • methotrexate • vincristine • revumenib (SNDX-5613) • fludarabine IV • Asparlas (calaspargase pegol-mknl) • Starasid (cytarabine ocfosfate)
    9ms
    Calaspargase Pegol in Adults With ALL (clinicaltrials.gov)
    P2/3, N=122, Recruiting, Institut de Recherches Internationales Servier | Trial completion date: Aug 2026 --> Feb 2027
    Trial completion date
    |
    Asparlas (calaspargase pegol-mknl)
    9ms
    CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov)
    P1, N=20, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Phase classification: P1b --> P1 | Trial primary completion date: Sep 2027 --> Nov 2024
    Phase classification • Trial primary completion date
    |
    Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Asparlas (calaspargase pegol-mknl)
    10ms
    Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL) (clinicaltrials.gov)
    P2, N=154, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • vincristine • daunorubicin • navitoclax (ABT 263) • Oncaspar liquid (pegaspargase) • nelarabine • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
    10ms
    Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma (clinicaltrials.gov)
    P3, N=440, Recruiting, Children's Oncology Group | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    CRLF2 (Cytokine Receptor Like Factor 2) • PNPLA3 (Patatin Like Phospholipase Domain Containing 3) • SOD2 (Superoxide Dismutase 2)
    |
    Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl)
    12ms
    A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia (clinicaltrials.gov)
    P2, N=78, Recruiting, Children's Oncology Group | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    MLL rearrangement
    |
    cytarabine • methotrexate • vincristine • revumenib (SNDX-5613) • Oncaspar liquid (pegaspargase) • fludarabine IV • Asparlas (calaspargase pegol-mknl) • Starasid (cytarabine ocfosfate)
    12ms
    Real-World Treatment Patterns Among Patients with Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) Who Initiated an Asparaginase Treatment after the Approval of Recombinant Erwinia (Rylaze) (ASH 2023)
    Four asparaginase molecules were included in this study, 2 Erwinia-derived - recombinant Erwinia(Rylaze) and native Erwinia (Erwinaze), and 2 E. coli-derived - pegaspargase (Oncaspar) and calaspargase pegol-mknl (Asparlas). Limitations of this study included the nature of the database used, containing mostly outpatient data, and the relatively short study time frame. Future studies with additional data are needed to fully understand the real-world asparaginase use patterns in these patient populations.
    Clinical • HEOR • Real-world evidence • Real-world
    |
    Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
    12ms
    Long-Acting E. coli-Derived Asparaginase Potentiates the Anti-Leukemic Effect of BCL2 Inhibition, but Not MCL1 Inhibition, in Preclinical Models of Acute Myeloid Leukemia (ASH 2023)
    Our previous studies have shown that pegcrisantaspase (PegC), a long-acting pegylated crisantaspase, synergizes with the BCL2 inhibitor, Venetoclax (Ven), to kill several AML cell lines and patient-derived primary AML cells with complex karyotype in vitro and in vivo in a xenograft mouse model... Using a panel of 4 human AML cell lines (MOLM14, MV411, MonoMac6, HL60) as well as primary AML patient samples, weestablished the anti-leukemic activity of the BCL2 inhibitor S55746 and the MCL1 inhibitor S63845 alone and in combination with the long-acting E. coli asparaginase, calaspargase pegol-mknl (CalPegA)... We report that the E. coli asparaginase, CalPegA, enhances the anti-leukemic effect of the BCL2 inhibitor, S55746, but does not impact the activity of the MCL1 inhibitor, S63845, in AML cell lines, patient derived primary AML samples, and in an AML xenograft mouse model. Ongoing studies are further investigating the anti-leukemic mechanism of S55476/S63845 + CalPegA and examining the efficacy and pharmacodynamic/pharmacokinetic effects of these agents in a patient derived xenograft model of AML.
    Preclinical
    |
    EIF4EBP1 (Eukaryotic translation initiation factor 4E binding protein 1)
    |
    Venclexta (venetoclax) • S63845 • Asparlas (calaspargase pegol-mknl) • S55746 • Asparec (PEGylated recombinant Erwinia chrysantemi-derived L-asparaginase)
    1year
    A Study Comparing the Combination of Dasatinib and Chemotherapy Treatment With or Without Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or Philadelphia Chromosome-Like (Ph-Like) ABL-Class B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov)
    P3; N=680; Not yet recruiting; Sponsor:National Cancer Institute (NCI)
    New P3 trial
    |
    ABL1 (ABL proto-oncogene 1) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • CD19 (CD19 Molecule) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • CSF1R (Colony stimulating factor 1 receptor)
    |
    CD19 expression
    |
    TruSight RNA Pan-Cancer Panel
    |
    dasatinib • imatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Starasid (cytarabine ocfosfate)
    1year
    Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma (clinicaltrials.gov)
    P1, N=40, Recruiting, New York Medical College | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • Adcetris (brentuximab vedotin) • prednisone • Asparlas (calaspargase pegol-mknl)
    1year
    AALL1621: Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=80, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD22 (CD22 Molecule)
    |
    CD22 expression
    |
    cytarabine • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • leucovorin calcium • Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl) • Starasid (cytarabine ocfosfate)
    1year
    Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma (clinicaltrials.gov)
    P3, N=440, Recruiting, Children's Oncology Group | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CRLF2 (Cytokine Receptor Like Factor 2)
    |
    Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl)
    over1year
    A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia (clinicaltrials.gov)
    P2, N=78, Not yet recruiting, Children's Oncology Group | Initiation date: Jun 2023 --> Oct 2023
    Trial initiation date • Combination therapy
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    MLL rearrangement
    |
    cytarabine • methotrexate • vincristine • revumenib (SNDX-5613) • Oncaspar liquid (pegaspargase) • fludarabine IV • Asparlas (calaspargase pegol-mknl) • Starasid (cytarabine ocfosfate)
    over1year
    Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma (clinicaltrials.gov)
    P3, N=440, Not yet recruiting, Children's Oncology Group | Initiation date: May 2023 --> Oct 2023
    Trial initiation date
    |
    CRLF2 (Cytokine Receptor Like Factor 2)
    |
    Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl)
    over1year
    Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma (clinicaltrials.gov)
    P2/3, N=793, Active, not recruiting, St. Jude Children's Research Hospital | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BCL2 (B-cell CLL/lymphoma 2) • CEP72 (Centrosomal Protein 72)
    |
    dasatinib • cytarabine • bortezomib • doxorubicin hydrochloride • Jakafi (ruxolitinib) • cyclophosphamide • etoposide IV • Blincyto (blinatumomab) • methotrexate • vincristine • prednisone • daunorubicin • Zolinza (vorinostat) • clofarabine • idarubicin hydrochloride • Oncaspar liquid (pegaspargase) • nelarabine • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • thioguanine • Purixan (mercaptopurine oral suspension) • prednisolone
    over1year
    A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia (clinicaltrials.gov)
    P2, N=78, Not yet recruiting, Children's Oncology Group
    New P2 trial • Combination therapy
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    MLL rearrangement
    |
    cytarabine • methotrexate • vincristine • revumenib (SNDX-5613) • Oncaspar liquid (pegaspargase) • fludarabine IV • Asparlas (calaspargase pegol-mknl) • Starasid (cytarabine ocfosfate)
    over1year
    AALL1631: Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P3, N=475, Recruiting, Children's Oncology Group | Trial completion date: Mar 2027 --> Sep 2027 | Trial primary completion date: Mar 2027 --> Sep 2027
    Trial completion date • Trial primary completion date • Combination therapy
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • CSF1R (Colony stimulating factor 1 receptor)
    |
    BCR-ABL1 fusion
    |
    TruSight RNA Pan-Cancer Panel
    |
    imatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Neupogen (filgrastim) • Starasid (cytarabine ocfosfate) • dexrazoxane