bleximenib (JNJ-6617) / J&J - LARVOL DELTA (2024)

Table of Contents
CR109124: A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: May 2024 ➔ Mar 2025 Combination therapy • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 CR108998: A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (clinicaltrials.gov) - P1/2 | N=350 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=150 ➔ 350 | Trial completion date: Feb 2026 ➔ Oct 2027 Enrollment change • Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 A PHASE 1B STUDY OF THE MENIN-KMT2A INHIBITOR JNJ-75276617 IN COMBINATION WITH VENETOCLAX AND AZACITIDINE IN RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA WITH ALTERATIONS IN KMT2A OR NPM1 (EHA 2024) - P1, P1/2 | "In this first analysis of a Phase 1b study exploring the triplet combination of JNJ-75276617+VEN+AZA in RRKMT2A-altered and NPM1m AML, the safety profile has been acceptable, with no DLTs observed and theRP2D(s) yet to be determined. To date, no AEs of DS, QTcF prolongation or TLS have been reported. Preliminary antileukemic efficacy with this triplet combination in RR AML was demonstrated, including in ptspreviously exposed to VEN." Combination therapy • P1 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Neutropenia • Oncology • Thrombocytopenia • HEY1 • KMT2A • NPM1 Preclinical efficacy of potent and selective menin-KMT2A inhibitor JNJ-75276617 in KMT2A- and NPM1-altered leukemias. (PubMed, Blood) - P1, P1/2 | "JNJ-75276617 demonstrated synergistic effects with gilteritinib in vitro in AML cells harboring KMT2A-r. JNJ-75276617 further exhibited synergistic effects with venetoclax and azacitidine in AML cells bearing KMT2A-r in vitro, and significantly increased survival in mice...A co-crystal structure of menin in complex with JNJ-75276617 indicates a unique binding mode distinct from other menin-KMT2A inhibitors, including revumenib. JNJ-75276617 is being clinically investigated for acute leukemias harboring KMT2A or NPM1 alterations, as a monotherapy for relapsed/refractory (R/R) acute leukemia (NCT04811560), or in combination with AML-directed therapies (NCT05453903)." Journal • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • KMT2A • MEIS1 • NPM1 PHASE 1B STUDY OF MENIN-KMT2A INHIBITOR JNJ-75276617 IN COMBINATION WITH VENETOCLAX/AZACITIDINE OR HIGH INTENSITY CHEMOTHERAPY IN NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA WITH KMT2A/NPM1 ALTERATIONS (EHA 2024) - "This abstract is embargoed until Friday, June 14, 2024 (09:00 CEST). Presentation during EHA2024: All (e)Poster presentations will be made available as of Friday, June 14, 2024 (09:00 CEST) and will be accessible for on-demand viewing until Thursday, August 15, 2024 on the Congress platform." Combination therapy • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 (ICKSH 2024) - "For BCP-ALL, this mainly concerns the introduction of blinatumomab and inotuzumab ozogamicin, as well as the recently developed menin inhibitor revumenib, which is mainly be of relevance for KMT2A-rearranged (infant) ALL. Other menin inhibitors are also under development, such as ziftomenib and JNJ-75276617. Other targeted therapy options are mainly relevant in Philadelphia-chromosome positive leukemias, and in adult ALL the concept of che- mo-free induction therapy is already under development consisting of combinations of tyrosine kinase inhibitors (TKIs) such as imatinib, da- satinib or ponatinib, in combination with with steroids or blinatumomab, and challenging the need for SCT in this disease...Also for T-cell ALL, newer therapy options are available including CAR T-cell therapy, for example the allogenic off-the-shelf, fractricide-resistant CD7-targeted CAR-T cell therapy studies in the WU-CART-007 study. For AML, immunotherapy is less well advanced, but next to..." Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer • Pediatrics • Solid Tumor • CBFA2T3 • CD123 • CD7 • FLT3 • GLIS2 • IL3RA • KMT2A • NUP98 CR108998: A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P1 ➔ P1/2 Phase classification • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 CR108998: A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=110 ➔ 150 Enrollment change • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 Preclinical Efficacy of the Menin-KMT2A Inhibitor JNJ-75276617 in Combination with Venetoclax and Azacitidine in AML (ASH 2023) - P1 | "Hypomethylating agents (e.g. azacitidine, decitabine) in combination with venetoclax have significantly improved clinical outcomes for AML patients and have become a preferred frontline treatment for AML patients ≥75 years of age, or who have comorbidities that preclude use of intensive induction chemotherapy. These studies suggest that the doublet combinations of either JNJ-75276617 plus venetoclax or azacitidine, or the triplet combination could potentially provide a beneficial treatment option for KMT2A- or NPM1-altered AML, and support the recently initiated clinical trial investigating JNJ-75276617 in combination with AML-directed therapies, including venetoclax and azacitidine (NCT05453903). JNJ-75276617 is also being clinically investigated as a monotherapy for R/R acute leukemia (NCT04811560)." Combination therapy • Preclinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • MEIS1 • NPM1 A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P1b ➔ P1 Combination therapy • Phase classification • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 A First-in-Human Phase 1 Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Adult Patients with Relapsed/Refractory Acute Leukemia Harboring KMT2A or NPM1 Alterations (ASH 2023) - P1 | "Dose escalation in 75276617ALE1001 is ongoing with the RP2D(s) yet to be determined. Pts in dose expansion will receive JNJ-75276617 at the identified RP2D(s). Preliminary results of this FIH Phase 1 study demonstrate that JNJ-75276617 monotherapy has an acceptable safety profile, encouraging antileukemic activity, and emerging biologic activity consistent with the proposed mechanism of action in pts with R/R acute leukemia harboring KMT2A or NPM1 alterations." Clinical • P1 data • Acute Myelogenous Leukemia • Anemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • Thrombocytopenia • Transplantation • FLT3 • HOXA9 • ITGAM • KMT2A • MEIS1 • NPM1 ASH: Novel menin inhibitors show promise for patients with advanced acute myeloid leukemias (Eurekalert) - P1 | N=110 | NCT04811560 | Sponsor: Janssen Research & Development, LLC | "According to data from a Phase I trial led by Elias Jabbour, M.D., professor of Leukemia, the menin inhibitor JNJ-75276617 showed early clinical activity in patients with relapsed or refractory acute leukemias and genetic alterations in KMT2A or NPM1, which are associated with poor clinical outcomes. Among 66 patients able to be evaluated after one month of treatment, JNJ-75276617 monotherapy reduced bone marrow disease burden in 71%, and 33 of those patients had a decrease in bone marrow blasts of more than 50%. Median time to first response was less than two months. Similar response rates were observed across patient groups with both genetic alterations." P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2026 ➔ Jan 2030 Combination therapy • Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • KMT2A • NPM1 • NUP214 • NUP98 A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2025 ➔ Oct 2025 Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 Targeting the undruggable: menin inhibitors ante portas. (PubMed, J Cancer Res Clin Oncol) - "To date at least six different menin-MLL inhibitors are undergoing clinical evaluation as first- and second-line monotherapy in acute leukaemias: DS-1594, BMF-219, JNJ-75276617, DSP-5336, revumenib, and ziftomenib, however, only for revumenib and ziftomenib early clinical data have been reported. The clinical development of novel menin-MLL inhibitors is well in line with the currently ongoing paradigm shift towards targeted therapies seen in the AML treatment landscape. Moreover, the clinical assessment of combinations of these inhibitors with established therapy options in AML could be the fuel for an improved outcome of MLL/NPM1 patients." Journal • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • MEIS1 • NPM1 Pharmacological Characterization of JNJ-75276617, a Menin-KMT2A Inhibitor, As Targeted Treatment for KMT2A-Altered and NPM1-Mutant Acute Leukemia (ASH 2022) - P1 | "JNJ-75276617 is a novel, orally bioavailable, potent, and selective protein-protein interaction inhibitor of the binding between KMT2A (wild-type [WT] and fusion) and menin. JNJ-75276617 binds with high affinity to the KMT2A binding pocket on human, mouse, and dog menin. JNJ-75276617 has a high biochemical potency across species evaluated by a hom*ogenous time-resolved fluorescence (HTRF) assay." Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • ITGAM • KMT2A • MEIS1 • NPM1 A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2026 ➔ Jun 2025 Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2025 ➔ Jun 2026 Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 A Phase I/Ib Study of JNJ-75276617 in Pediatric and Young Adult Participants with Relapsed/Refractory Acute Leukemias Estudio fase I/Ib de JNJ-75276617 en sujetos pediátricos y adultos jóvenes con leucemias agudas en recaída o refractarias (clinicaltrialsregister.eu) - P1 | N=80 | Ongoing | Sponsor: Janssen-Cilag International NV Combination therapy • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • HOXA9 • KMT2A • MEIS1 • NPM1 • NUP214 • NUP98 A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC | Initiation date: Dec 2022 ➔ Feb 2024 Combination therapy • Trial initiation date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • KMT2A • NPM1 • NUP214 • NUP98 A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov) - P1b | N=150 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2024 ➔ Jan 2026 Combination therapy • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC Combination therapy • New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • KMT2A • NPM1 • NUP214 • NUP98 A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov) - P1b | N=150 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting Combination therapy • Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2024 ➔ Jun 2025 Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov) - P1b | N=150 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC Combination therapy • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1 References

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Likelihood of Approval and Phase Transition Success Rate Model - JNJ-6617 in Relapsed Acute Myeloid LeukemiaA First-in-Human Phase 1 Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Adult Patients with Relapsed/Refractory Acute Leukemia Harboring KMT2A or NPM1 AlterationsNews - bleximenib (JNJ-6617) - LARVOL VERI

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