MEDI-570 / AstraZeneca - LARVOL DELTA

Progression-Free Survival and Overall Survival in Relapsed/Refractory T-cell Lymphoma Patients on Chemotherapy vs Targeted Therapy (SOHO 2025) - "Options include chemotherapy, brentuximab, pralatrexate, romidepsin, and duvelisib...Other treatment options used were immunotherapy (n = 2), tipifarnib (n = 2), pentostatin (n = 1), MEDI-570 (n = 1), duvelisib (n = 1), and vorinostat (n = 1)... Our study showed a benefit to the use of targeted therapy in relapsed/refractory TCL that was more pronounced in the third-line setting, likely due to increased resistance to chemotherapy with repeated exposure."

Clinical • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • TNFRSF8

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma (clinicaltrials.gov) - P1 | N=21 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2025 ➔ Dec 2025 | Trial primary completion date: Aug 2023 ➔ Dec 2024

IO biomarker • Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma (clinicaltrials.gov) - P1 | N=21 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=38 ➔ 21 | Trial completion date: Dec 2023 ➔ Feb 2025 | Trial primary completion date: Dec 2023 ➔ Aug 2023

Enrollment change • IO biomarker • Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4

[VIRTUAL] A Phase I Study of Anti-ICOS Antibody MEDI-570 for Relapsed/Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL) and Angioimmunoblastic T-Cell Lymphoma (AITL) (NCI-9930) (ASH 2020) - P1 | "MEDI-570 was safe, well tolerated and showed promising clinical activity in poor-risk refractory and heavily pretreated AITL. A RP2D was established. MEDI-570 results in sustained reduction of the targeted ICOS+T lymphocytes."

P1 data • Cutaneous T-cell Lymphoma • Dermatology • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Renal Disease • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • Transplantation • ICOS

Targeting the Inducible T-cell Costimulator (ICOS) in patients with Relapsed/Refractory T-Follicular Helper Phenotype Peripheral T-Cell and Angioimmunoblastic T-Cell Lymphoma. (PubMed, Clin Cancer Res) - P1 | "MEDI-570 was well tolerated and showed promising clinical activity in refractory AITL. MEDI-570 resulted in sustained reduction of ICOS+ T lymphocytes."

Journal • Hematological Disorders • Hematological Malignancies • Immune Modulation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD4 • ICOS

Targeting the Inducible T-cell Costimulator (ICOS) in patients with Relapsed/Refractory T-Follicular Helper Phenotype Peripheral T-Cell and Angioimmunoblastic T-Cell Lymphoma (Clin Cancer Res) - P1 | N=38 | NCT02520791 | "Twenty-three patients were enrolled and received MEDI-570 at five dose levels (0.01 mg/kg to 3 mg/kg). Sixteen (70%) had angioimmunoblastic T-cell lymphoma (AITL); median age was 67 years (29 - 86) and the median prior lines of therapies was 3 (1 - 16). Most common grade 3 or 4 adverse events were decreased CD4+ T-cells (57%), lymphopenia (22%), anemia (13%), and infusion related reactions (9%). No DLTs were observed. The RP2D was determined at 3 mg/kg. Analysis of T-cell subsets showed reductions in CD4+ICOS+ T cells reflecting its effects on TFH cells. The response rate in AITL was 44%."

P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma (clinicaltrials.gov) - P1 | N=38 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Follicular Lymphoma • Hematological Malignancies • Immune Modulation • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma (clinicaltrials.gov) - P1; N=38; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Follicular Lymphoma • Hematological Malignancies • Immune Modulation • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4 • MRI

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma (clinicaltrials.gov) - P1; N=38; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Cutaneous T-cell Lymphoma • Dermatology • Follicular Lymphoma • Hematological Malignancies • Immune Modulation • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma (clinicaltrials.gov) - P1; N=38; Recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Follicular Lymphoma • Hematological Malignancies • Immune Modulation • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

AstraZeneca Demonstrates Strength in Hematology With Robust Data at ASH 2020 (Businesswire) - “AstraZeneca will present new research aimed at addressing key unmet needs facing patients with blood cancers at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, held virtually from 5 to 8 December 2020.The Company will present 27 abstracts spanning five medicines and potential new medicines and eight different hematology conditions that demonstrate the Company’s commitment to advancing hematology research and treatments for patients living with hematologic malignancies.”

Clinical data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2b; N=792; Recruiting; Sponsor: AstraZeneca; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cardiovascular • Coronary Artery Disease • Heart Failure • Immunology • Inflammation • Myocardial Infarction

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2b; N=792; Not yet recruiting; Sponsor: AstraZeneca

Clinical • New P2b trial • Cardiovascular • Coronary Artery Disease • Heart Failure • Immunology • Inflammation • Myocardial Infarction

A Study to Evaluate the Efficacy and Safety of MEDI6570 in Participantswith a Prior Heart Attack (clinicaltrialsregister.eu) - P2; N=792; Ongoing; Sponsor: AstraZeneca AB

Clinical • New P2 trial • Cardiovascular • Immunology • Inflammation • Myocardial Infarction

Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1; N=88; Completed; Sponsor: MedImmune LLC; Active, not recruiting ➔ Completed

Trial completion • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma (clinicaltrials.gov) - P1; N=46; Not yet recruiting; Sponsor: National Cancer Institute (NCI); Initiation date: Nov 2015 ➔ Jul 2016

Trial initiation date • Biosimilar • Hematological Malignancies • Immunology • Non-Hodgkin’s Lymphoma • Oncology

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma (clinicaltrials.gov) - P1; N=46; Recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Trial primary completion date

Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1; N=88; Active, not recruiting; Sponsor: MedImmune LLC; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: MedImmune LLC; Trial completion date: Jan 2020 ➔ Jun 2020; Trial primary completion date: Jan 2020 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date