ASP1948 / Astellas - LARVOL DELTA

KEYNOTE-A87: A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=190 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Phase classification: P1b ➔ P1

Combination therapy • Metastases • Phase classification • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • PD-L1

KEYNOTE KN-A87: A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=190 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Mar 2023 | Trial primary completion date: Jun 2023 ➔ Mar 2023

Combination therapy • Metastases • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • PD-L1

KEYNOTE KN-A87: A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=190 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Apr 2024 ➔ Jun 2023 | Trial primary completion date: Apr 2024 ➔ Jun 2023

Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • PD-L1

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Astellas Pharma Inc | Active, not recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Feb 2022 | Trial primary completion date: Jun 2022 ➔ Feb 2022

Trial completion • Trial completion date • Trial primary completion date • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

KEYNOTE KN-A87: A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=190; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Active, not recruiting; N=479 ➔ 190

Clinical • Combination therapy • Enrollment change • Enrollment closed • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MRI • PD-L1

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=9; Active, not recruiting; Sponsor: Astellas Pharma Inc; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Dec 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MRI

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Astellas Pharma Inc; N=12 ➔ 18

Clinical • Enrollment change • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • ALK • EGFR

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Astellas Pharma Inc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • ALK • EGFR

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Astellas Pharma Inc

Clinical • New P1 trial • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • ALK • EGFR

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Astellas Pharma Inc; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • ALK • EGFR

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=9; Active, not recruiting; Sponsor: Astellas Pharma Inc; Recruiting ➔ Active, not recruiting; N=18 ➔ 9

Clinical • Enrollment change • Enrollment closed • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: Astellas Pharma Inc; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • ALK • EGFR

KEYNOTE KN-A87: A Study of ASP1948, Targeting an Immune Modulatory Receptor, in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=479; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Nov 2023 ➔ Apr 2024; Trial primary completion date: Nov 2023 ➔ Apr 2024

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • 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-A87: A Study of ASP1948, Targeting an Immune Modulatory Receptor, in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=479; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Jul 2022 ➔ Nov 2023; Trial primary completion date: Jul 2022 ➔ Nov 2023

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR