encelimab (TSR-033) / AnaptysBio - LARVOL DELTA

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

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

Metastases • 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

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

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

Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung 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=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 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

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

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

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

Clinical • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung 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=111; Active, not recruiting; Sponsor: Tesaro, Inc.; Recruiting ➔ Active, not recruiting; N=55 ➔ 111

Clinical • Combination therapy • Enrollment change • Enrollment closed • 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

Clinical • Enrollment change • Trial completion date • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

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

Clinical • Trial primary completion date • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

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

Clinical • Trial primary completion date • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

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

Clinical • New P1 trial • P1 data • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

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

Clinical • Trial completion date • Trial primary completion date • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

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

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

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

Clinical • Enrollment open • P1 data • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

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

Clinical • Trial completion date • Trial primary completion date • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

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

Clinical • Enrollment change • P1 data • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

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

Tesaro announces data presentations at the SITC 2018 Annual Meeting (GlobeNewswire) - P1, N=627; AMBER (NCT02817633); P1, N=540; GARNET (NCT02715284); P1, N=260; CITRINO (NCT03250832); Sponsor: Tesaro; "Tesaro...announced that data from a total of five abstracts will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting from November 7-11, 2018...'we are excited that several abstracts will be presented highlighting data from our rapidly advancing immuno-oncology portfolio, including an oral presentation of the first clinical data of TSR-022, our anti-TIM-3 antibody, in combination with TSR-042, our anti-PD-1 antibody'...'In addition, data from the GARNET trial of TSR-042 in recurrent NSCLC patients...[phase 1 dose escalation study (CITRINO) of TSR-033 in advanced solid tumors] will be featured in a poster presentation'."

P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology

Tesaro announces immuno-oncology data presentations at SITC 2018 Annual Meeting (GlobeNewswire) - P1, N=30; CITRINO (NCT03250832); Sponsor: Tesaro; "There were no Grade ≥3 treatment-related treatment emergent adverse events reported. Exposure and peripheral receptor occupancy increased in a dose proportional manner from 20 milligrams to 720 milligrams.These preliminary findings indicate that TSR-033 was generally well tolerated across multiple dose levels, with a safety profile consistent to those of other immune checkpoint inhibitors. Enrollment is ongoing for patients treated with TSR-033 in combination with 500 milligrams of TSR-042."

Enrollment status • P1 data • Oncology