ASP1951 / Astellas - LARVOL DELTA

KEYNOTE-B02: A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=119 | Terminated | Sponsor: Astellas Pharma Global Development, Inc. | Completed ➔ Terminated; Study was terminated for lack of efficacy.

Combination therapy • Metastases • Trial termination • Colorectal 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 • PD-L1

KEYNOTE-B02: A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Phase classification: P1b ➔ P1

Phase classification • Colorectal 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 • PD-L1

KEYNOTE KN-B02: A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=120 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • 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 • PD-L1

KEYNOTE KN-B02: A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=120 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Mar 2024 ➔ Dec 2023 | Trial primary completion date: Mar 2024 ➔ Dec 2023

Combination therapy • Trial completion date • Trial primary completion date • Cervical 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 • PD-L1

Notice Regarding Impairment Loss for Products under Development (Astellas Press Release) - "It has decided to terminate the development of the GITR agonistic antibody ASP1951, which is currently in Phase 1 study for cancer patients. As a result of this termination, Astellas will book an impairment loss of goodwill as other expenses."

Discontinued • Oncology

KEYNOTE KN-B02: A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=120 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Recruiting ➔ Active, not recruiting | N=435 ➔ 120

Combination therapy • Enrollment change • Enrollment closed • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • PD-L1

KEYNOTE KN-B02: A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=435; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Oct 2023 ➔ Apr 2024; Trial primary completion date: Oct 2023 ➔ Apr 2024

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • PD-L1

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

A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=435; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Active, not recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • ALK • EGFR

A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=435; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer

A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1b; N=435; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Phase classification: P1 ➔ P1b; N=213 ➔ 435

Clinical • Combination therapy • Enrollment change • Phase classification

A Study of ASP1951 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=213; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.

Clinical • New P1 trial