latikafusp (AMG 256) / Amgen, BeiGene - LARVOL DELTA

Translatability of findings from cynomolgus monkey to human suggests a mechanistic role for IL-21 in promoting immunogenicity to an anti-PD-1/IL-21 mutein fusion protein. (PubMed, Front Immunol) - "ADA responses were not associated with any type of adverse event. The AMG 256 program represents a unique case where nonclinical studies informed on the risk of immunogenicity in humans, due to the IL-21-driven nature of the response."

Journal • Preclinical • Oncology • Solid Tumor • IL21

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Metastases • Trial completion • Oncology • Solid Tumor

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Nov 2024 ➔ Sep 2023 | Trial primary completion date: Nov 2024 ➔ Sep 2023

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

[VIRTUAL] Design and rationale of a phase 1 study evaluating AMG 256, a novel, targeted, IL-21 receptor agonist and anti-PD-1 antibody, in patients with advanced solid tumors (SITC 2020) - P1 | "Secondary objectives will evaluate PK parameters, preliminary antitumor activity (objective response, duration of response, progression-free survival, disease control rate, duration of stable disease, overall survival), and immunogenicity of AMG 256 via incidence of anti-AMG 256 antibodies. Results N/A Conclusions N/A"

Clinical • IO Biomarker • P1 data • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • IL21

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: Amgen | N=100 ➔ 34 | Trial completion date: May 2026 ➔ Nov 2024 | Trial primary completion date: May 2026 ➔ Nov 2024

Enrollment change • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ May 2026 | Trial primary completion date: Oct 2025 ➔ May 2026

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Amgen | Trial primary completion date: Aug 2023 ➔ Oct 2025

Trial primary completion date • Oncology • Solid Tumor

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Amgen; Trial completion date: Mar 2025 ➔ Aug 2025; Trial primary completion date: Mar 2023 ➔ Aug 2023

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

[VIRTUAL] Design and rationale of a phase 1 study evaluating AMG 256, a novel, targeted, IL-21 receptor agonist and anti-PD-1 antibody, in patients with advanced solid tumors (SITC 2020) - P1 | "Secondary objectives will evaluate PK parameters, preliminary antitumor activity (objective response, duration of response, progression-free survival, disease control rate, duration of stable disease, overall survival), and immunogenicity of AMG 256 via incidence of anti-AMG 256 antibodies. Results N/A Conclusions N/A"

Clinical • IO Biomarker • P1 data • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • IL21

[VIRTUAL] Design and rationale of a phase 1 study evaluating AMG 256, a novel, targeted, PD-1 antibody x IL-21 mutein bifunctional fusion protein, in patients with advanced solid tumors (AACR 2021) - P1 | "The primary endpoints are incidence of dose-limiting toxicities and adverse events, MTD, and recommended phase 2 dose. Secondary objectives will evaluate PK parameters, preliminary antitumor activity (objective response, duration of response, progression-free survival, disease control rate, duration of stable disease, overall survival), and immunogenicity of AMG 256 via incidence of anti-AMG 256 antibodies."

Clinical • P1 data • Brain Cancer • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • IL21

Amgen Reports First Quarter 2021 Financial Results (PRNewswire) - "The following programs continue to enroll patients in dose escalation studies: (i) BiTE® molecules AMG 330 and AMG 427, targeting CD33 and fms-like tyrosine kinase 3 (FLT3), respectively, for acute myeloid leukemia; (ii) AMG 176, a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1) for hematologic malignancies; (iii) HLE BiTE molecules AMG 199 and AMG 910, targeting mucin 17 (MUC17) and claudin 18.2 (CLDN18.2), respectively, for gastric and gastroesophageal junction cancer; (iv) AMG 509, a bivalent T-cell engager XmAb® 2+1 antibody targeting six transmembrane epithelial antigen of the prostate 1 (STEAP1) for prostate cancer. AMG 256, a bifunctional interleukin-21 agonist for PD-1 positive solid tumors."

Enrollment status • Acute Myelogenous Leukemia • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer • Solid Tumor

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Amgen; Trial completion date: Aug 2025 ➔ Mar 2025; Trial primary completion date: Nov 2023 ➔ Mar 2023

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Amgen; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=100; Not yet recruiting; Sponsor: Amgen; Trial completion date: Jul 2022 ➔ Aug 2025; Trial primary completion date: Feb 2022 ➔ Nov 2023

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=100; Not yet recruiting; Sponsor: Amgen

Clinical • New P1 trial • Oncology • Solid Tumor