encelimab (TSR-033) / AnaptysBio - LARVOL DELTA

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=475 | Recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Oct 2024 ➔ Jul 2025 | Trial primary completion date: Oct 2023 ➔ Dec 2024

First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=475 | Recruiting | Sponsor: GlaxoSmithKline

Metastases • New P1 trial • Hepatocellular Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=475 | Recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Jul 2025 ➔ Apr 2027 | Trial primary completion date: Dec 2024 ➔ Apr 2025

First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=369 | Recruiting | Sponsor: Tesaro, Inc. | N=873 ➔ 369 | Trial completion date: Jun 2022 ➔ Jul 2023

Enrollment change • First-in-human • Trial completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=369 | Recruiting | Sponsor: Tesaro, Inc. | Trial primary completion date: Jul 2021 ➔ Apr 2022

First-in-human • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=369 | Recruiting | Sponsor: Tesaro, Inc. | Trial primary completion date: Apr 2022 ➔ Jul 2021

First-in-human • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=369 | Recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Oct 2023 ➔ Jun 2024 | Trial primary completion date: Oct 2021 ➔ Jun 2023

First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=369 | Recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Jun 2024 ➔ Oct 2024 | Trial primary completion date: Jun 2023 ➔ Oct 2023

First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=819 | Recruiting | Sponsor: Tesaro, Inc. | N=627 ➔ 819 | Trial completion date: Jun 2020 ➔ Jun 2022 | Trial primary completion date: Dec 2019 ➔ Dec 2020

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=819 | Recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Jun 2022 ➔ Jun 2020 | Trial primary completion date: Dec 2020 ➔ Dec 2019

First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=873 | Recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Jun 2020 ➔ Jun 2022 | Trial primary completion date: Dec 2019 ➔ Jun 2021

First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=402 | Not yet recruiting | Sponsor: Tesaro, Inc.

First-in-human • New P1 trial • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=402 | Recruiting | Sponsor: Tesaro, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=463 | Active, not recruiting | Sponsor: Tesaro, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2025 ➔ Mar 2027

Enrollment closed • First-in-human • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=627 | Recruiting | Sponsor: Tesaro, Inc. | N=447 ➔ 627

Enrollment change • First-in-human • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

LAG-3 antagonists for cancer treatment: an updated patent review (2020-2025). (PubMed, Expert Opin Ther Pat) - "The trend shows that monospecific antibodies against LAG-3 continue to be the main antagonists, followed by multispecific t, treatment methods using known LAG-3 antagonists, LAG-3 binding peptides, and LAG-3 binding small molecules. The monospecific antibodies encelimab, miptenalimab, and the bispecific antibodies tobemstomig, IBI323, ABL501, fanastomig, and FS118 are added, during this period, to the potential drugs targeting LAG-3."

Journal • Review • Oncology • CD4 • CD8 • IFNG • LAG3

CITRINO: phase 1 dose escalation study of anti-LAG-3 antibody encelimab alone or in combination with anti-PD-1 dostarlimab in patients with advanced/metastatic solid tumours. (PubMed, BJC Rep) - P1 | "Encelimab has a manageable safety profile as a monotherapy and in tested combinations; however, anti-tumour activity was limited."

IO biomarker • Journal • P1 data • CNS Disorders • Colorectal Cancer • Myasthenia Gravis • Oncology • Solid Tumor

CITRINO: Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=111 | Completed | Sponsor: Tesaro, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Nov 2022 ➔ Feb 2023 | Trial primary completion date: Nov 2022 ➔ Jun 2022

Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

CITRINO: Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=111 | Active, not recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Dec 2021 ➔ Nov 2022 | Trial primary completion date: Dec 2021 ➔ Nov 2022

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A phase 1 dose escalation study of TSR-033, an antiLAG3 monoclonal antibody, in patients with advanced solid tumors (SITC 2018) - P1; "Adverse events were manageable and consistent with the safety profiles of other immune checkpoint inhibitors. Dose escalation of TSR-033 in combination with TSR-042 (anti-PD-1) is ongoing."

Clinical • IO biomarker • P1 data • PD(L)-1 Biomarker • Solid Tumor

CITRINO: Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=111; Active, not recruiting; Sponsor: Tesaro, Inc.; Recruiting ➔ Active, not recruiting; N=55 ➔ 111

Clinical • Combination therapy • Enrollment change • Enrollment closed • Oncology • Solid Tumor

Quantifying the efficacy of checkpoint inhibitors on CD8 cytotoxic T cells for immunotherapeutic applications via single-cell interaction. (PubMed, Cell Death Dis) - "We also found that the combination of TSR-042 and TSR-033 appears to synergistically increase tumor cell killing and the single-cell level. This study provides a novel single-cell-based assessment of the impact these checkpoint inhibitors have on cellular interactions with CD8 T cells."

Checkpoint inhibition • Clinical • Journal • Breast Cancer • Oncology • Solid Tumor

CITRINO: Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=55; Recruiting; Sponsor: Tesaro, Inc.; Trial completion date: Feb 2021 ➔ Sep 2021; Trial primary completion date: Feb 2021 ➔ Sep 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • F2

Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=55; Recruiting; Sponsor: Tesaro, Inc.; N=200 ➔ 55

Clinical • Combination therapy • Enrollment change • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • F2

TESARO announces second-quarter 2018 operating results [Lung Cancer & Immuno-oncology] (GlobeNewswire) - "Key development milestones: [1] Initiate Phase 2 registration enabling trial of TSR-042 versus standard of care in first-line NSCLC in early 2019; [2] Following availability of initial data in Q4 2018 from Phase 2 JASPER study of ZEJULA in combination with an anti-PD-1 inhibitor, submit data for presentation at a medical meeting in 1H 2019; [3] Continue to enroll CITRINO trial (combination of TSR-033 plus TSR-042) and report Phase 1 monotherapy dose-escalation data for TSR-033 at the SITC Annual Meeting."

Enrollment status • P1 data • P2 data • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology