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    DRUG:

    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)

    i
    Other names: RG7446 SC, RO5541267 SC, MPDL-3280A SC, atezolizumab/rHuPH20, RG7446/rHuPH20, MPDL3280A SC, RG-7446 SC, RO-5541267 SC, MPDL 3280A SC, RG 7446 SC, RO 5541267 SC
    Company:
    Roche
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    4ms
    ORIGAMA: Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice (clinicaltrials.gov)
    P2/3, N=49, Terminated, Hoffmann-La Roche | N=440 --> 49 | Trial completion date: Jul 2026 --> Jul 2024 | Active, not recruiting --> Terminated; Study terminated by sponsor.
    Enrollment change • Trial completion date • Trial termination • HEOR
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    5ms
    ORIGAMA: Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice (clinicaltrials.gov)
    P2/3, N=440, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed • HEOR
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over1year
    A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=176, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over1year
    A phase II, multicenter, open-label study of PolyPEPI1018 in combination with atezolizumab in participants with relapsed or refractory microsatellite-stable metastatic colorectal (MSS mCRC) cancer (Oberto-301): Initial results (ESMO 2023)
    Methods Patients with MSS mCRC who have progressed on 2-3 lines of prior chemotherapy regimen received PolyPEPI1018 (1.2 mg, sc) and atezolizumab (1,200 mg, iv) Q3W. PolyPEPI1018 induced immunological responses at both peripheral and tumor level, converted "cold" tumor into "hot", although to date no responses per RECIST have been noted. The study is on-going.
    Combination therapy • P2 data • Clinical • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker • Metastases
    |
    MSI (Microsatellite instability) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    Immunoscore®
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) • PolyPEPI 1018
    over1year
    IMscin001 Part 2: A randomised phase III, open-label, multicentre study examining the pharmacokinetics (PK), efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous in previously treated locally advanced or metastatic non-small-cell lung cancer and PK comparison to other approved indications. (PubMed, Ann Oncol)
    Compared with IV, atezolizumab SC demonstrated noninferior drug exposure at cycle 1. Efficacy, safety, and immunogenicity were similar between arms and consistent with the known profile for atezolizumab IV. Similar drug exposure and clinical outcomes following SC and IV administration support the use of atezolizumab SC as an alternative to atezolizumab IV.
    P3 data • PK/PD data • Journal • Metastases
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over1year
    ORIGAMA: Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice (clinicaltrials.gov)
    P2/3, N=440, Recruiting, Hoffmann-La Roche | Phase classification: P2 --> P2/3
    Phase classification • HEOR
    |
    PD-L1 (Programmed death ligand 1) • IL6 (Interleukin 6)
    |
    PD-L1 expression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over1year
    A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=175, Recruiting, Hoffmann-La Roche | Trial completion date: Mar 2024 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over1year
    ORIGAMA: Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice (clinicaltrials.gov)
    P2, N=440, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open • HEOR
    |
    PD-L1 (Programmed death ligand 1) • IL6 (Interleukin 6)
    |
    PD-L1 expression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    almost2years
    Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=37, Recruiting, University of Southern California | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    almost2years
    ORIGAMA: Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice (clinicaltrials.gov)
    P2, N=440, Not yet recruiting, Hoffmann-La Roche
    New P2 trial • HEOR
    |
    PD-L1 (Programmed death ligand 1) • IL6 (Interleukin 6)
    |
    PD-L1 expression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    2years
    Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=37, Not yet recruiting, University of Southern California | Trial completion date: Sep 2026 --> Dec 2026 | Initiation date: Sep 2022 --> Dec 2022 | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    2years
    A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=140, Recruiting, Hoffmann-La Roche | Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Apr 2023 --> Jul 2023
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    2years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=438, Active, not recruiting, Hoffmann-La Roche | Trial completion date: May 2024 --> Dec 2024
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over2years
    Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=37, Not yet recruiting, University of Southern California | Trial completion date: May 2025 --> Sep 2026 | Initiation date: May 2022 --> Sep 2022 | Trial primary completion date: May 2025 --> Sep 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over2years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=437, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over2years
    Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=37, Not yet recruiting, University of Southern California
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over2years
    A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=140, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    almost3years
    A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=140, Not yet recruiting, Hoffmann-La Roche
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    almost4years
    A Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients with Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrialsregister.eu)
    P3, N=375, Ongoing, F. Hoffman-La Roche Ltd.
    Clinical • New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    4years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=375, Recruiting, Hoffmann-La Roche | Phase classification: P1/2 --> P3 | Trial completion date: Jun 2024 --> Mar 2024
    Clinical • Phase classification • Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    4years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=375, Recruiting, Hoffmann-La Roche | N=260 --> 375 | Trial completion date: Sep 2023 --> Jun 2024 | Trial primary completion date: Apr 2021 --> Jun 2022
    Clinical • Enrollment change • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over4years
    CMP-001-003: Study Evaluating CMP-001 in Combination With Atezolizumab in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1b, N=29, Completed, Checkmate Pharmaceuticals | Active, not recruiting --> Completed | N=70 --> 29 | Trial completion date: Jun 2020 --> Dec 2019
    Clinical • Trial completion • Enrollment change • Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR T790M
    |
    vidutolimod (CMP-001) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over4years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2; Trial completion date: Nov 2022 --> Sep 2023
    Trial completion date • Clinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    5years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2; Phase classification: P1 --> P1/2
    Phase classification • Clinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over5years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1; Phase classification: P1/2 --> P1
    Phase classification • Clinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    over5years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2; Phase classification: P1 --> P1/2
    Phase classification • Clinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    almost6years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1; Not yet recruiting --> Recruiting
    Enrollment open • Clinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    almost6years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1; Phase classification: P1/2 --> P1
    Phase classification • Clinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    6years
    IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2; N=245; Not yet recruiting; Sponsor:Hoffmann-La Roche
    PK/PD data • New P1 trial • New P1/2 trial • Clinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)