lomvastomig (RG7769) / Roche - LARVOL DELTA

A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus (clinicaltrials.gov) - P2 | N=206 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Jan 2025 | Trial primary completion date: Jun 2025 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=134 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Metastases • Trial completion • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma

A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=134 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Apr 2024 ➔ Aug 2024 | Trial primary completion date: Apr 2024 ➔ Aug 2024

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma

A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=134 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Aug 2023 ➔ Apr 2024 | Trial primary completion date: Aug 2023 ➔ Apr 2024

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma

A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus (clinicaltrials.gov) - P2 | N=210 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma • CD4 • CD8 • HAVCR2 • LAG3 • PD-1

[VIRTUAL] RG7769 (PD1-TIM3), a novel heterodimeric avidity-driven T cell specific PD-1/TIM-3 bispecific antibody lacking Fc-mediated effector functions for dual checkpoint inhibition to reactivate dysfunctional T cells (AACR-II 2020) - P1 | "RG7769 binds to PD-1 with higher affinity than pembrolizumab and nivolumab. In summary, these preclinical data support the use of RG7769 as a monotherapy and as combination partner for the treatment of patients with solid/hematological tumors. A phase I study is currently ongoing in patients with advanced metastatic solid tumors (NCT03708328)."

Checkpoint inhibition • IO biomarker • Melanoma • Oncology • Solid Tumor • FCGR2A • IFNG • LAG3 • PD-1 • PDCD1LG2

A Dose Escalation and Expansion Study of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=134 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Feb 2023 ➔ Aug 2023 | Trial primary completion date: Feb 2023 ➔ Aug 2023

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma

A Study of RO7121661 and RO7247669 Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Oct 2024 ➔ May 2025 | Trial primary completion date: Oct 2024 ➔ May 2025

IO biomarker • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma • CD4 • CD8 • HAVCR2 • LAG3 • PD-1

A Dose Escalation and Expansion Study of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=134 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: May 2023 ➔ Feb 2023 | Trial primary completion date: May 2023 ➔ Feb 2023

Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma

RO7121661: NME submission in US for solid tumors in 2024 or later (Roche) - FY 2021 Results: Regulatory submission in EU for solid tumors in 2024 or later

BLA • European regulatory • Oncology • Solid Tumor

A Dose Escalation and Expansion Study of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=134; Active, not recruiting; Sponsor: Hoffmann-La Roche; Recruiting ➔ Active, not recruiting; N=280 ➔ 134

Clinical • Enrollment change • Enrollment closed • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma

RO7121661: NME submission in US for solid tumors in 2024 or later (Roche) - Q2 2021 Results: Regulatory submission in EU for solid tumors in 2024 or later

BLA • European regulatory • Oncology • Solid Tumor

A Study of RO7121661 and RO7247669 Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus (clinicaltrials.gov) - P2; N=255; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • IO biomarker • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma • CD4 • CD8 • HAVCR2 • LAG3 • PD-1

MORPHEUS mUC: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (clinicaltrials.gov) - P1/2; N=735; Recruiting; Sponsor: Hoffmann-La Roche; N=385 ➔ 735

Clinical • Enrollment change • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • PD-L1

A Study of RO7121661 and RO7247669 Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus (clinicaltrials.gov) - P2; N=255; Not yet recruiting; Sponsor: Hoffmann-La Roche

Clinical • IO biomarker • New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma • CD4 • CD8 • HAVCR2 • LAG3 • PD-1

A human receptor occupancy assay to measure anti-PD-1 binding in patients with prior anti-PD-1. (PubMed, Cytometry A) - "Using this reagent, we developed a total-drug-bound RO assay format for RG7769, a bi-specific P329GLALA containing mAb targeting PD-1 and TIM3 on T cells...We show that this is due to steric hindrance exerted by competing mAbs masking the available drug binding sites. Our findings highlight the importance of quantitative mAb assessment in addition to relative RO especially in the context of patients who have previously received anti-PD-1 treatment."

Clinical • IO biomarker • Journal • Oncology • HAVCR2

MORPHEUS mUC: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy (clinicaltrials.gov) - P1/2; N=385; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Mar 2023 ➔ Nov 2024; Trial primary completion date: Sep 2020 ➔ Nov 2024

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • Urothelial Cancer • PD-L1

MORPHEUS mUC: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy (clinicaltrials.gov) - P1/2; N=385; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Feb 2021 ➔ Mar 2023

Clinical • Trial completion date • Oncology • Solid Tumor • Urothelial Cancer • PD-L1

A Dose Escalation and Expansion Study of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=300; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Sep 2022 ➔ May 2023; Trial primary completion date: Sep 2022 ➔ May 2023

Clinical • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

Newly added product (clinicaltrials.gov) - P1, NSCLC, Metastatic Melanoma

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