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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
Enrollment closed • HEOR
|
PD-L1 (Programmed death ligand 1)
|
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
1year
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
Phase classification • HEOR
|
PD-L1 (Programmed death ligand 1) • IL6 (Interleukin 6)
|
PD-L1 expression
|
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
over1year
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
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
New P2 trial • 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, 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
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
2years
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
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
Enrollment open
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
almost3years
New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
almost4years
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
Trial completion date • Clinical
|
EGFR (Epidermal growth factor receptor)
|
Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
5years
Phase classification • Clinical
|
EGFR (Epidermal growth factor receptor)
|
Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
over5years
Phase classification • Clinical
|
EGFR (Epidermal growth factor receptor)
|
Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
over5years
Phase classification • Clinical
|
EGFR (Epidermal growth factor receptor)
|
Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
almost6years
Enrollment open • Clinical
|
EGFR (Epidermal growth factor receptor)
|
Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
almost6years
Phase classification • Clinical
|
EGFR (Epidermal growth factor receptor)
|
Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
6years
PK/PD data • New P1 trial • New P1/2 trial • Clinical
|
EGFR (Epidermal growth factor receptor)
|
Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)