ASP8374 / Astellas, Dana-Farber Cancer Institute - LARVOL DELTA

ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor

KEYNOTE-A72: A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=169 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Phase classification: P1b ➔ P1

Phase classification • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR

ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Dec 2022 ➔ Dec 2024

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Immune Modulation • Oncology • Solid Tumor

ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Recruiting ➔ Active, not recruiting | N=24 ➔ 14

Enrollment change • Enrollment closed • Brain Cancer • Glioblastoma • Glioma • Immune Modulation • Oncology • Solid Tumor

ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial primary completion date: Jun 2022 ➔ Oct 2022

Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • Immune Modulation • Oncology • Solid Tumor

KEYNOTE KN-A72: A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=169 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Active, not recruiting ➔ Completed

Checkpoint inhibition • Combination therapy • Trial completion • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR

ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Dana-Farber Cancer Institute | N=65 ➔ 24

Enrollment change • Brain Cancer • Glioblastoma • Glioma • Immune Modulation • Oncology • Solid Tumor • MRI

ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Glioblastoma • Glioma • Immune Modulation • Oncology • Solid Tumor

ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - P1; N=65; Not yet recruiting; Sponsor: Dana-Farber Cancer Institute; Initiation date: Sep 2021 ➔ Dec 2021

Clinical • Trial initiation date • Brain Cancer • Glioblastoma • Glioma • Immune Modulation • Oncology • Solid Tumor • MRI

KEYNOTE KN-A72: A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=169; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Mar 2022 ➔ Jun 2022; Trial primary completion date: Aug 2021 ➔ Mar 2022

Checkpoint inhibition • Clinical • Combination therapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MRI

Characterization of ASP8374, a fully-human, antagonistic anti-TIGIT monoclonal antibody. (PubMed, Cancer Treat Res Commun) - "When used in combination with pembrolizumab, an anti-programmed death-1 (PD-1) antibody, ASP8374 induced higher T-cell activation in vitro than either treatment alone. In an additional syngeneic mouse tumor model (CT26), while mSEC1 alone did not demonstrate anti-tumor efficacy, mSEC1 combined with an anti-PD-1 antibody enhanced anti-tumor efficacy above that of the anti-PD-1 antibody alone. These data provide evidence that ASP8374 has therapeutic potential for advanced malignancies."

Journal • Immune Modulation • Inflammation • Oncology • TIGIT

ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - P1; N=65; Not yet recruiting; Sponsor: Dana-Farber Cancer Institute

New P1 trial • Brain Cancer • Glioblastoma • Glioma • Immune Modulation • Oncology • Solid Tumor

KEYNOTE KN-A72: A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=169; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; N=300 ➔ 169; Trial completion date: Feb 2023 ➔ Mar 2022; Trial primary completion date: Dec 2021 ➔ Aug 2021

Checkpoint inhibition • Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR

Astellas cuts Potenza anti-TIGIT asset in quarterly cull (FierceBiotech) - "In 2018, Astellas spent $405 million to buy out long-term biotech partner Potenza Therapeutics and its small group of early-stage cancer drugs...These included phase 1 drug ASP8374/PTZ-201, an anti-TIGIT antibody immune checkpoint inhibitor; ASP1948/PTZ-329, an anti-NRP1 antibody inhibiting T-regulatory cells; and ASP1951/PTZ-522....Now that list is down by one, as Astellas announced in its financial update today that it was culling PTZ-201, saying simply that it: 'Discontinued Phase 1 program for cancer.'"

Pipeline update • Oncology • Solid Tumor

KEYNOTE KN-A72: A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=300; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Active, not recruiting

Checkpoint inhibition • Clinical • Combination therapy • Enrollment closed • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • KLK3

A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=300; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Apr 2022 ➔ Feb 2023; Trial primary completion date: Jul 2021 ➔ Dec 2021

Checkpoint inhibition • Clinical • Combination therapy • Trial completion date • Trial primary completion date • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • KLK3

Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Astellas Pharma Inc; Active, not recruiting ➔ Completed; Trial completion date: Dec 2022 ➔ Jun 2020; Trial primary completion date: Dec 2022 ➔ Jun 2020

Checkpoint inhibition • Clinical • Trial completion • Trial completion date • Trial primary completion date • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Thoracic Cancer

Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=6; Active, not recruiting; Sponsor: Astellas Pharma Inc; Recruiting ➔ Active, not recruiting

Checkpoint inhibition • Clinical • Enrollment closed • ALK • EGFR

A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=363; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial primary completion date: Mar 2022 ➔ Jul 2021

Checkpoint inhibition • Clinical • Combination therapy • Trial primary completion date

A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=200; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Clinical • Combination therapy • Enrollment open

A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=400; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Phase classification: P1 ➔ P1b; N=200 ➔ 400; Trial completion date: May 2021 ➔ Mar 2022; Trial primary completion date: May 2021 ➔ Mar 2022

Checkpoint inhibition • Clinical • Combination therapy • Enrollment change • Phase classification • Trial completion date • Trial primary completion date

A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=200; Not yet recruiting; Sponsor: Astellas Pharma Global Development, Inc.

Checkpoint inhibition • Clinical • Combination therapy • New P1 trial

Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Astellas Pharma Inc; Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Clinical • Enrollment open

Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=9; Not yet recruiting; Sponsor: Astellas Pharma Inc

Checkpoint inhibition • Clinical • New P1 trial