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    DRUG:

    Lymphir (denileukin diftitox-cxdl)

    i
    Other names: E7777
    Company:
    Citius Oncology, Eisai
    Drug class:
    IL-2 stimulant
    Related drugs:
    3d
    Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. (PubMed, J Clin Oncol)
    Efficacy and safety results show that DD-cxdl would potentially fulfill a serious, unmet medical need for patients with R/R CTCL.
    Journal
    |
    IL2 (Interleukin 2)
    |
    Ontak (denileukin diftitox) • Lymphir (denileukin diftitox-cxdl)
    1year
    A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study) (clinicaltrials.gov)
    P=N/A, N=118, Completed, Eisai Inc. | Recruiting --> Completed | N=85 --> 118 | Trial completion date: Nov 2026 --> Mar 2023 | Trial primary completion date: Nov 2026 --> Mar 2023
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    Lymphir (denileukin diftitox-cxdl)
    1year
    Targeting regulatory T cells by E7777 enhances CD8 T-cell-mediated anti-tumor activity and extends survival benefit of anti-PD-1 in solid tumor models. (PubMed, Front Immunol)
    This study evaluated whether adding E7777 (a new formulation of denileukin diftitox [DD]) improved the efficacy of anti-PD-1 antibody therapy. Treatment with E7777 was safe and well-tolerated. Combined E7777 and anti-PD-1 therapy was well tolerated and more effective than monotherapy with either drug.
    Preclinical • Journal
    |
    IL2 (Interleukin 2)
    |
    Ontak (denileukin diftitox) • Lymphir (denileukin diftitox-cxdl)
    2years
    Safety and Tolerability of E7777 (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma: Results from Pivotal Study 302 (ASH 2022)
    No new safety signals were observed with E7777 when compared to the safety profile of ONTAK. There is no evidence of cumulative toxicity. Most patients had at least 1 TEAE which were mostly Grade 1/2.
    Clinical
    |
    IL2 (Interleukin 2)
    |
    Lymphir (denileukin diftitox-cxdl)
    2years
    Efficacy and Safety of E7777 (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma: Results from Pivotal Study 302 (ASH 2022)
    Approximately half (34 of 69; 49.3%) of patients had prior exposure to 1 or more FDA-approved targeted therapeutics: romidepsin, brentuximab, or mogamulizumab. In study 302, E7777 at a dose of 9 mcg/kg/day demonstrated clinical efficacy and clinically meaningful benefit in heavily pre-treated patients with relapsed/refractory CTCL. The ORR of 36.2% per IRC (42.3% by investigator assessment) showed that a substantial proportion of these heavily pretreated patients experienced clinical benefit after E7777 treatment similar to ONTAK. The observed tumor responses were rapid, durable, and deep.
    Clinical
    |
    IL2 (Interleukin 2)
    |
    Adcetris (brentuximab vedotin) • Istodax (romidepsin) • Poteligeo (mogamulizumab-kpkc) • Lymphir (denileukin diftitox-cxdl)
    2years
    T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=70, Recruiting, Haider Mahdi | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition • Metastases
    |
    MSI (Microsatellite instability) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Lymphir (denileukin diftitox-cxdl)
    over2years
    Preclinical and clinical researches of Denileukin Diftitox (Genetical Recombination) (Remitoro), a novel agent for T-cell lymphoma (PubMed, Nihon Yakurigaku Zasshi)
    Therefore, safety monitoring activities have been continued along with alerting related events. Based on these results, E7777 obtained a new drug approval in Japan in March 2021 for the indication of relapsed or refractory PTCL/CTCL.
    Preclinical • Journal
    |
    IL2RA (Interleukin 2 receptor, alpha)
    |
    IL2RA expression
    |
    Lymphir (denileukin diftitox-cxdl)
    over2years
    T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=70, Not yet recruiting, Haider Mahdi | Initiation date: Mar 2022 --> Jul 2022
    Trial initiation date • Checkpoint inhibition
    |
    MSI (Microsatellite instability) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Lymphir (denileukin diftitox-cxdl)
    over2years
    T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=70, Not yet recruiting, Haider Mahdi | Trial completion date: Jan 2027 --> Dec 2027 | Trial primary completion date: Jan 2025 --> Dec 2025
    Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    MSI (Microsatellite instability) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Lymphir (denileukin diftitox-cxdl)
    almost3years
    T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=70, Not yet recruiting, Haider Mahdi
    New P1/2 trial • Checkpoint inhibition
    |
    MSI (Microsatellite instability) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Lymphir (denileukin diftitox-cxdl)
    almost3years
    A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov)
    P3, N=115, Completed, Eisai Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2)
    |
    Lymphir (denileukin diftitox-cxdl)
    3years
    A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov)
    P3, N=115, Active, not recruiting, Eisai Inc. | Trial completion date: Sep 2021 --> Feb 2022 | Trial primary completion date: Sep 2021 --> Feb 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2)
    |
    Lymphir (denileukin diftitox-cxdl)
    over3years
    A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov)
    P3, N=115, Active, not recruiting, Eisai Inc. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2)
    |
    Lymphir (denileukin diftitox-cxdl)