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DRUG:

flotetuzumab (MGD006)

i
Other names: MGD006, S 80880, S80880, CD3xCD123 DART, MGD 006, RES234
Company:
MacroGenics
Drug class:
CD3 agonist, CD123 inhibitor
Related drugs:
3ms
Post-transplant Flotetuzumab for AML (clinicaltrials.gov)
P1, N=3, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Completed | N=16 --> 3 | Trial completion date: Dec 2027 --> Jun 2024 | Trial primary completion date: Dec 2025 --> Jun 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Post-transplantation
|
IL3RA (Interleukin 3 Receptor Subunit Alpha)
|
flotetuzumab (MGD006)
4ms
Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) (clinicaltrials.gov)
P2, N=11, Terminated, Washington University School of Medicine | Trial completion date: Mar 2026 --> Jul 2024 | Active, not recruiting --> Terminated; The sponsor is no longer supporting the drug
Trial completion date • Trial termination
|
flotetuzumab (MGD006)
4ms
Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) (clinicaltrials.gov)
P2, N=11, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | N=25 --> 11 | Trial completion date: Jun 2029 --> Mar 2026 | Trial primary completion date: Jul 2028 --> Mar 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
|
flotetuzumab (MGD006)
6ms
Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) (clinicaltrials.gov)
P2, N=25, Recruiting, Washington University School of Medicine | Trial completion date: Dec 2027 --> Jun 2029 | Trial primary completion date: Jan 2026 --> Jul 2028
Trial completion date • Trial primary completion date
|
flotetuzumab (MGD006)
7ms
Flotetuzumab as a salvage immunotherapy in advanced CD123-positive hematological malignancies, a phase 1 pilot study. (PubMed, Leuk Lymphoma)
Responses only occurred in Cohort B, with a partial response in one patient with Hodgkin's lymphoma and morphological complete remission in the bone marrow in one patient with blastic plasmacytoid dendritic cell neoplasm. In conclusion, flotetuzumab had a manageable safety profile in advanced CD123-positive hematological malignancies.
P1 data • Journal • IO biomarker • Metastases
|
CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
|
CD123 positive • CD123 expression • IL3RA expression • IL3RA positive
|
flotetuzumab (MGD006)
11ms
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies (clinicaltrials.gov)
P1, N=13, Active, not recruiting, City of Hope Medical Center | Trial completion date: Nov 2023 --> May 2026 | Trial primary completion date: Nov 2023 --> May 2026
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
|
CD123 expression
|
flotetuzumab (MGD006)
11ms
PEPN1812: Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=16, Active, not recruiting, Children's Oncology Group | N=47 --> 16 | Trial completion date: Oct 2023 --> Sep 2024
Enrollment change • Trial completion date
|
CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
|
CD123 expression • IL3RA expression
|
cytarabine • flotetuzumab (MGD006) • Starasid (cytarabine ocfosfate)
1year
Spatial Technologies Reveal the Immune Landscape of Pediatric Acute Myeloid Leukemia (ASH 2023)
Moreover, we acquired an additional dataset of pre-treatment immune-related gene expression profiling obtained from the BM of 30 flotetuzumab-treated (CD3 x CD123 bispecific antibody) refractory/relapsed (R/R) adult AML patients (NCT02152956; Vadakekolathu et al., 2020) for TIDE-based immune deconvolution (Jiang et al., 2018)...Lastly, for the first time, we identified TLS-like aggregates in the BM of AML patients, which have been associated with immunotherapy response in many cancers (Schumacher & Thommen, 2022). Additional studies to further characterize the function and relevance of these lymphoid aggregates are ongoing.
Clinical • Tumor mutational burden • IO biomarker
|
TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • KMT2A (Lysine Methyltransferase 2A) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
|
TMB-L • MLL rearrangement
|
nCounter® PanCancer IO 360™ Panel
|
flotetuzumab (MGD006)
1year
Spatially Resolved Transcriptomics Unveils Unique T-Cell Dysfunctional States and Prognostic Gene Expression Signatures in TP53-Mutated Acute Myeloid Leukemia (ASH 2023)
We have previously shown that TP53 abnormalities are associated with a pro-inflammatory and immunosuppressive tumor microenvironment (TME), including high CD274 and FoxP3 expression, with dysfunctional natural killer (NK)/CD8+ T-cell states and with response to flotetuzumab, a CD123 × CD3 bispecific T-cell engager...Conclusions Spatial gene programs of leukemia stemness, T-cell dysfunction and immune suppression are enriched in TP53-m AML. It remains to be determined whether TP53-m AML with a pre-existing but ineffective T-cell response may be amenable to T cell-targeting immunotherapies.
IO biomarker
|
PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • CD8 (cluster of differentiation 8) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD4 (CD4 Molecule) • S100A8 (S100 Calcium Binding Protein A8) • S100A9 (S100 Calcium Binding Protein A9) • CD3D (CD3d Molecule) • FOXP3 (Forkhead Box P3) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • PRDM1 (PR/SET Domain 1) • IL1B (Interleukin 1, beta) • ZEB2 (Zinc Finger E-Box Binding Homeobox 2) • CDCP1 (CUB Domain Containing Protein 1)
|
TP53 mutation • TP53 wild-type • TP53 expression • FOXP3 expression
|
flotetuzumab (MGD006)
1year
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies (clinicaltrials.gov)
P1, N=13, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=40 --> 13
Enrollment closed • Enrollment change • Metastases
|
PD-L1 (Programmed death ligand 1) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
|
CD123 expression • IL3RA expression
|
flotetuzumab (MGD006)
1year
Modeling Flotetuzumab‑Associated Cytokine Release Syndrome (CRS) in AML Using In Vitro and In Vivo Preclinical Models (SOHO 2023)
The in vitro killing assay shows that T-cells from the spleens of immune competent C57/Bl6 hCD123eHOM mice bind to both FLZ and hCD123 on transduced murine leukemia cells. Co- culture with T-cells + target cells + FLZ showed killing at 24 hours compared to controls. T-cell activation and proliferation were noted based on cell surface markers.
Preclinical • IO biomarker
|
CD8 (cluster of differentiation 8) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
|
CD123 expression • IL3RA expression
|
flotetuzumab (MGD006)
almost2years
CD123 a Therapeutic Target for Acute Myeloid Leukemia and Blastic Plasmocytoid Dendritic Neoplasm. (PubMed, Int J Mol Sci)
Some of these agents have shown promising results at the clinical level, including tagraxofusp (CD123 conjugated with diphtheria toxin) for the treatment of BPDCN and IMGN632 (anti-CD123 drug-conjugate), and flotetuzumab (bispecific anti-CD123 and anti-CD3 monoclonal antibody) for the treatment of AML. However, the therapeutic efficacy of CD123-targeting treatments is still unsatisfactory and must be improved through new therapeutic strategies and combined treatments with other antileukemic drugs.
Review • Journal
|
CD123 (Interleukin 3 Receptor Subunit Alpha)
|
CD123 expression • CD123 overexpression
|
flotetuzumab (MGD006) • Elzonris (tagraxofusp-erzs) • pivekimab sunirine (IMGN632)
almost2years
Flotetuzumab and other T-Cell Immunotherapies Upregulate MHC Class II Expression on Acute Myeloid Leukemia Cells. (PubMed, Blood)
Finally, we report that FLZ-induced MHC-II upregulation is mediated by IFN-γ. In conclusion, we provide evidence that T-cell immunotherapies targeting relapsed AML can kill AML via both MHC-independent mechanisms and by an MHC-dependent mechanism through local release of IFN-γ and subsequent upregulation of MHC-II expression.
Journal • IO biomarker
|
IFNG (Interferon, gamma) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD33 (CD33 Molecule)
|
MHC-II expression
|
flotetuzumab (MGD006)
almost2years
A Phase 1, First-in-Human, Dose-Escalation Study of MGD024, a CD123 x CD3 Bispecific Dart® Molecule, in Patients with Relapsed or Refractory CD123-Positive (+) Hematologic Malignancies (ASH 2022)
Of note, the CD123-directed therapy tagraxofusp has now become the standard of care (SoC) for blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Pemmaraju NEJM 2019)...This new construct permits intermittent intravenous (IV) dosing due to a longer half-life (Alderson ASH 2021) compared with the first-generation DART molecule flotetuzumab, a continuous-infusion molecule that showed preliminary single-agent activity in refractory acute myeloid leukemia (AML) (Uy Blood 2021)...Secondary objectives include pharmacokinetics, immunogenicity, preliminary assessment of MGD024 clinical activity, and preliminary evaluation of safety/efficacy of tocilizumab in the management of MGD024-induced CRS...Response evaluation is determined using modified European LeukemiaNet (ELN) 2017 criteria for ALM and ALL; International Working Group (IWG) 2006 criteria for MDS; Lugano 2014 criteria for cHL; ELN 2020 criteria for CML; 2017 consensus criteria for HCL; IWG-Myeloproliferative Neoplasms Research and Treatment (MRT) & European Competence Network on Mastocytosis (ECNM) 2013 criteria for ASM; and modified criteria from Pemmaraju NEJM 2019 for BPDCN. Patients benefitting from MGD024 may continue to receive MGD024 after completion of the study treatment period, at physician discretion.
Clinical • P1 data
|
CD123 (Interleukin 3 Receptor Subunit Alpha)
|
CD123 positive • CD123 expression
|
flotetuzumab (MGD006) • Elzonris (tagraxofusp-erzs) • Actemra IV (tocilizumab) • MGD024
2years
Modeling Flotetuzumab-Associated CRS in AML Using in Vitro and in Vivo Preclinical Models (ASH 2022)
The in vitro killing assay shows that T-cells from the spleens of immune competent C57Bl/6 hCD123eHOM mice recognize FLZ and hCD123 on transduced murine leukemia cells. Co-culture with T-cells + target cells + FLZ showed killing at 24 hours compared to controls. T-cell activation and proliferation were noted based on cell surface markers.
Preclinical • IO biomarker
|
FLT3 (Fms-related tyrosine kinase 3) • DNMT3A (DNA methyltransferase 1) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL2RA (Interleukin 2 receptor, alpha) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CD69 (CD69 Molecule) • IL7R (Interleukin 7 Receptor)
|
CD123 expression
|
flotetuzumab (MGD006)
2years
Safety and Activity of Flotetuzumab in Pediatric and Young Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia: Results from the COG PEPN1812 Phase 1 Trial (ASH 2022)
We report the safety, RP2D, and preliminary activity of the CD123xCD3 bispecific antibody flotetuzumab in children with r/r AML. Despite the frequent occurrence of mild CRS and CLS, flotetuzumab was determined to be safe and tolerable at the RP2D of 500 ng/kg/day (DL1) with an overall response rate (CR + PR) of 20% in children and AYAs with r/r AML. This study supports the potential of CD123-targeting immunotherapies in pediatric patients with AML and provides rationale for future phase 2/3 investigation.
Clinical • P1 data • IO biomarker
|
CD123 (Interleukin 3 Receptor Subunit Alpha)
|
CD123 expression
|
flotetuzumab (MGD006)
2years
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
P1/2, N=246, Terminated, MacroGenics | Trial completion date: Dec 2023 --> Jul 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2023 --> Jul 2022; Business decision
Trial completion date • Trial termination • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
Jakafi (ruxolitinib) • flotetuzumab (MGD006)
over2years
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
P1/2, N=330, Active, not recruiting, MacroGenics | Recruiting --> Active, not recruiting | Trial completion date: Jan 2022 --> Dec 2023 | Trial primary completion date: Jan 2022 --> Jul 2023
Enrollment closed • Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
Jakafi (ruxolitinib) • flotetuzumab (MGD006)
over2years
Efficacy of Flotetuzumab in Combination with Cytarabine in Patient-Derived Xenograft Models of Pediatric Acute Myeloid Leukemia. (PubMed, J Clin Med)
MGD006 enhanced T-cell proliferation and decreased the burden of AML blasts in the peripheral blood with or without cytarabine treatment. These data demonstrate the efficacy of MGD006 in prolonging survival in pediatric AML PDX models in the presence of effector T cells and show that the inclusion of cytarabine in the treatment regimen does not interfere with MGD006 activity.
Preclinical • Journal • Combination therapy
|
CD123 (Interleukin 3 Receptor Subunit Alpha)
|
CD123 positive
|
cytarabine • flotetuzumab (MGD006)
almost3years
HOVON162AML: Study to Assess an Interphase Cycle With Flotetuzumab. (clinicaltrials.gov)
P2, N=0, Withdrawn, Stichting Hemato-Oncologie voor Volwassenen Nederland | N=25 --> 0 | Not yet recruiting --> Withdrawn
Clinical • Enrollment change • Trial withdrawal
|
NPM1 (Nucleophosmin 1)
|
NPM1 mutation
|
flotetuzumab (MGD006)
3years
Combinatorial Anti-Tumor Activity in Animal Models of a Novel CD123 x CD3 Bispecific Dart® Molecule (MGD024) with Cytarabine, Venetoclax or Azacitidine Supports Combination Therapy in Acute Myeloid Leukemia (ASH 2021)
Introduction: Notwithstanding recent progress, acute myeloid leukemia (AML) remains an incurable disease, particularly in patients (pts) with relapsing/refractory disorder or ineligible for intensive induction therapy (unfit pts). Consistent with its decreased affinity for CD3, MGD024 demonstrated reduced in vitro potency in killing CD123-positive target cells compared to flotetuzumab or RES234M1.1, but proportionally greater reduction in cytokine release. MGD024, however, achieved maximal cytolytic activity as flotetuzumab or RES234M1.1, albeit at increased concentrations. Similarly, MGD024 showed reduced potency in vivo against CD123-positive tumors compared to RES234M1.1; nevertheless, tumor growth reduction of the same magnitude as that observed with RES234M1.1 was attained at higher doses of MGD024 (0.5-1 mg/kg IV 2QW MGD024 vs.
Preclinical • Combination therapy • IO biomarker
|
CD123 (Interleukin 3 Receptor Subunit Alpha) • IL2RA (Interleukin 2 receptor, alpha)
|
CD123 positive
|
Venclexta (venetoclax) • cytarabine • azacitidine • flotetuzumab (MGD006) • MGD024
3years
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies (clinicaltrials.gov)
P1, N=40, Recruiting, City of Hope Medical Center | Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023
Clinical • Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
flotetuzumab (MGD006)
3years
Immune Evasion and Immunotherapy in Myeloid Malignancies - Live Q&A (ASH 2021)
Dr. Rutella will also review the cellular constituents and signaling pathways found to impact response to bispecific antibody immunotherapy, flotetuzumab...Dr. Gill will review this work and outline its implications for other immunotherapy targets and diseases.
IO biomarker
|
TP53 (Tumor protein P53) • CD19 (CD19 Molecule)
|
TP53 mutation
|
flotetuzumab (MGD006)
3years
HOVON162AML: Study to Assess an Interphase Cycle With Flotetuzumab. (clinicaltrials.gov)
P2, N=25, Not yet recruiting, Stichting Hemato-Oncologie voor Volwassenen Nederland
Clinical • New P2 trial
|
NPM1 (Nucleophosmin 1)
|
NPM1 mutation
|
flotetuzumab (MGD006)
over3years
An Update on the Clinical Evaluation of Antibody-Based Therapeutics in Acute Myeloid Leukemia. (PubMed, Curr Hematol Malig Rep)
Gemtuzumab ozogamicin, a CD33 directed antibody-drug conjugate, has provided the proof of concept for the potential efficacy of monoclonal antibody-based therapies in AML...The first-in-class anti-CD47 antibody magrolimab and anti-CD70 antibody cusatuzumab in combination with hypomethylating agent (HMA) azacitidine, in newly diagnosed AML, and flotetuzumab, a bispecific DART® (dual-affinity retargeting) antibody to CD3ε and CD123 as salvage option in relapsed/refractory AML appear promising...Ongoing research will define the choice of an appropriate complementary therapeutic agent in antibody-based combination therapy, and whether one or more than one antigen should be simultaneously targeted. Further studies will likely refine the role of antibody-based therapy in post hematopoietic cell transplant setting.
Clinical • Review • Journal
|
CD123 (Interleukin 3 Receptor Subunit Alpha) • CD33 (CD33 Molecule) • CD70 (CD70 Molecule)
|
azacitidine • Mylotarg (gemtuzumab ozogamicin) • magrolimab (ONO-7913) • flotetuzumab (MGD006) • cusatuzumab (ARGX-110)
almost4years
Clinical • New P1 trial
|
PD-L1 (Programmed death ligand 1)
|
flotetuzumab (MGD006)
almost4years
Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer (clinicaltrials.gov)
P2, N=0, Withdrawn, City of Hope Medical Center | N=52 --> 0 | Trial completion date: Dec 2021 --> Oct 2020 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2021 --> Oct 2020
Clinical • Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
flotetuzumab (MGD006)
4years
[VIRTUAL] Flotetuzumab and Other Cellular Immunotherapies Upregulate MHC Class II Expression on Acute Myeloid Leukemia Cells in Vitro and In Vivo (ASH 2020)
T-cell immunotherapies represent a promising treatment approach for AML patients relapsing after allo-HCT and may lead to enhanced immune recognition in the 30-50% of patients who relapse after allo-HCT. Based on these results, a clinical trial treating patients relapsing after allo-HCT with FLZ is planned.
IO biomarker
|
IFNG (Interferon, gamma) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD33 (CD33 Molecule) • CSF2 (Colony stimulating factor 2) • GLI2 (GLI Family Zinc Finger 2)
|
IFNG expression • CSF2 expression
|
flotetuzumab (MGD006)
4years
TP53 abnormalities correlate with immune infiltration and associate with response to flotetuzumab immunotherapy in AML. (PubMed, Blood Adv)
Patients with TP53 abnormalities who achieved a complete response experienced prolonged survival (median, 10.3 months; range, 3.3-21.3 months). These results encourage further study of flotetuzumab immunotherapy in patients with TP53-mutated AML.
Journal • PD(L)-1 Biomarker
|
TP53 (Tumor protein P53) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • CD123 (Interleukin 3 Receptor Subunit Alpha) • FOXP3 (Forkhead Box P3)
|
TP53 mutation • IFNG expression • FOXP3 expression
|
flotetuzumab (MGD006)
4years
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
P1/2, N=330, Recruiting, MacroGenics | N=179 --> 330 | Trial completion date: Apr 2021 --> Jan 2022 | Trial primary completion date: Dec 2020 --> Jan 2022
Clinical • Enrollment change • Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
flotetuzumab (MGD006)
4years
Flotetuzumab as Salvage Immunotherapy for Refractory Acute Myeloid Leukemia. (PubMed, Blood)
We have recently shown an association between an immune-infiltrated tumor microenvironment (TME) and resistance to cytarabine-based chemotherapy but responsiveness to flotetuzumab, a bispecific DART® antibody-based molecule to CD3ε and CD123...Stepwise dosing during week 1, pre-treatment dexamethasone, prompt use of tocilizumab and temporary dose reductions/interruptions successfully prevented severe IRR/CRS, resulting in acceptable tolerability...Flotetuzumab represents an innovative experimental approach associated with acceptable safety and encouraging evidence of activity in PIF/ER AML patients. Trial registration number: NCT02152956.
Journal
|
CD123 (Interleukin 3 Receptor Subunit Alpha)
|
cytarabine • dexamethasone • flotetuzumab (MGD006) • Actemra IV (tocilizumab)
over4years
Targeting the alpha subunit of IL-3 receptor (CD123) in patients with acute leukemia. (PubMed, Hum Vaccin Immunother)
There are currently 31 ongoing clinical trials examining the utility of CD123-based targeted therapies. Here we focus our review on current efforts to target CD123 in acute leukemia through various therapeutic constructs.
Clinical • Journal
|
CD123 (Interleukin 3 Receptor Subunit Alpha)
|
flotetuzumab (MGD006) • Elzonris (tagraxofusp-erzs)
over4years
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
P1/2, N=179, Recruiting, MacroGenics | Trial completion date: Apr 2020 --> Apr 2021 | Trial primary completion date: Jan 2020 --> Dec 2020
Clinical • Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
flotetuzumab (MGD006)
over4years
[VIRTUAL] TP53 abnormalities correlate with immune infiltration and are associated with response to flotetuzumab, an investigational immunotherapy, in acute myeloid leukemia (AACR-I 2020)
This study provides evidence for a correlation between IFN-γ-dominant immune subtypes of AML and TP53 abnormalities. The ORR seen in this patient subgroup encourages further study of this immunotherapeutic approach.
Tumor Mutational Burden • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • HRAS (Harvey rat sarcoma viral oncogene homolog) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IDO1 (Indoleamine 2,3-dioxygenase 1) • IRF1 (Interferon Regulatory Factor 1)
|
TP53 mutation • IRF1 expression
|
flotetuzumab (MGD006)