belrestotug (EOS-448) / GSK, Concentra Biosciences - LARVOL DELTA

Interim analysis of GALAXIES Lung-201: Phase II, randomized, open-label platform study of belrestotug plus dostarlimab in patients (pts) with previously untreated locally advanced/metastatic (LA/M) PD-L1 high (TPS >/=50%) non-small cell lung cancer (NSCLC) (ESMO 2024) - P2 | "At this IA, belrestotug + dostarlimab demonstrated clinically meaningful anti-tumor activity at each dose and a manageable safety profile, supporting further evaluation in pts with previously untreated, unresectable LA/M PD-L1 high NSCLC. 1. Reck M, et al."

Clinical • IO biomarker • Late-breaking abstract • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1 • TIGIT

A Phase 1 First-Time-in-Human, Open-Label Study of Nelistotug Administered to Patients with Advanced Solid Tumors. (PubMed, Clin Cancer Res) - "Nelistotug as monotherapy and in combination with dostarlimab and belrestotug had an acceptable safety and tolerability profile; however, efficacy was limited in this heavily pretreated patient population with advanced solid tumors."

Clinical • First-in-human • Journal • P1 data • Oncology • Solid Tumor • CD96 • TIGIT

GALAXIES Lung-301: A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=88 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Feb 2027 ➔ Aug 2027 | Trial primary completion date: Feb 2027 ➔ Jun 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

GALAXIES LUNG-201: A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) - P2 | N=351 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Feb 2027 ➔ Dec 2027 | Trial primary completion date: Feb 2027 ➔ Nov 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202 (clinicaltrials.gov) - P2 | N=316 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jul 2027 ➔ Dec 2027 | Trial primary completion date: Jul 2027 ➔ Sep 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=152 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=158 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Sep 2028 ➔ Aug 2027 | Trial primary completion date: Sep 2028 ➔ Aug 2027

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=107 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202 (clinicaltrials.gov) - P2 | N=316 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Immune checkpoint inhibitor–induced psoriasis successfully treated with tildrakizumab in an oncologic patient (EADV 2025) - " We present the case of a 53-year-old male with stage IVB squamous cell carcinoma of the lung (PD-L1 50%) enrolled in a clinical trial receiving combination immunotherapy with dostarlimab (anti–PD-1), belrestotug (anti– TIGIT), and nelistotug (anti–CD96)...Initial treatment with topical corticosteroids and vitamin D analogues plus oral acitretin at 25 mg/day for three months failed to produce significant improvement, the Psoriasis Area and Severity Index (PASI) was 12, body surface area (BSA) 10%, and Physician Global Assessment (PGA) 3... IL-23 inhibitors, such as tildrakizumab, have demonstrated a favorable safety profile in both clinical trials and real- world settings, including in patients with malignancies. In this case, tildrakizumab provided a fast and sustained therapeutic response in immune checkpoint inhibitor–induced psoriasis refractory to standard treatments, with no compromise in oncologic control. This case highlights its potential role in managing severe..."

Checkpoint inhibition • Clinical • Dermatology • Immunology • Inflammatory Arthritis • Lung Cancer • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Solid Tumor • Squamous Cell Carcinoma • CD96 • IL23A • PD-L1 • TIGIT

GALAXIES LUNG-201: A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) - P2 | N=351 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Oct 2028 ➔ Feb 2027 | Trial primary completion date: Oct 2025 ➔ Feb 2027

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

GALAXIES Lung-301: A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=88 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=1000 ➔ 88 | Trial completion date: Sep 2029 ➔ Feb 2027 | Trial primary completion date: Sep 2028 ➔ Feb 2027

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

GALAXIES LUNG-201: A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) - P2 | N=351 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

iTeos Reports Topline Interim Results from GALAXIES Lung-201 Study of Belrestotug + Dostarlimab in First-Line, PD-L1 High Non-Small Cell Lung Cancer Patients (GlobeNewswire) - P2 | N=340 | GALAXIES Lung-201 (NCT05565378) | N=360 | GALAXIES H&N-202 (NCT06062420) | Sponsor: GlaxoSmithKline | "The GALAXIES Lung-201 data continued to demonstrate clinically meaningful improvements in the trial’s primary endpoint of objective response rate (ORR), however the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression free survival in the belrestotug + dostarlimab combination cohorts versus dostarlimab monotherapy...an interim analysis of the GALAXIES H&N-202 Phase 2 trial showed a trend below the meaningful threshold for ORR in the belrestotug combination cohorts vs. dostarlimab monotherapy in PD-L1 positive head and neck squamous cell carcinoma...Based on these results, iTeos and GSK have made the decision to terminate the belrestotug development program and end the collaboration. All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301...is ending."

Commercial • Discontinued • P2 data • Trial status • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

iTeos Reports First Quarter 2025 Financial Results and Provides Business Updates (GlobeNewswire) - "Program Highlights:...(i) GALAXIES H&N-202: Interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet and triplet with nelistotug in first-line patients with PD-L1 positive recurrent/metastatic HNSCC anticipated in 2025 to include safety and ORR from >150 patients; (ii) TIG-006 HNSCC: Topline data from the TIG-006 study in cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in 2025 to include safety, ORR, and PFS from a total of 42 patients."

P2 data • Squamous Cell Carcinoma of Head and Neck

iTeos Reports First Quarter 2025 Financial Results and Provides Business Updates (GlobeNewswire) - "Program Highlights:...GALAXIES Lung-201: Topline interim data from open label Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, in first-line advanced / metastatic PD-L1 high NSCLC anticipated in 2Q25 to include safety, ORR, and ctDNA data from >240 patients, with pembrolizumab monotherapy ORR for 30 patients and PFS data from initial 124 patients treated. Data are expected to be submitted for presentation at a scientific congress in 2H 2025."

P2 data • Non Small Cell Lung Cancer

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 3 (clinicaltrials.gov) - P2 | N=62 | Completed | Sponsor: GlaxoSmithKline

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=107 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=244 ➔ 107 | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

iTeos Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "TIG-006 HNSCC: Topline data from the TIG-006 study in cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in 2025 to include safety, ORR, and PFS from a total of 42 patients....TRM-010: Investigative New Drug (IND) application was submitted and allowed to proceed for a Phase 1 of EOS-215. Patient enrollment is anticipated in 2Q25."

IND • New P1 trial • P1/2 data • Squamous Cell Carcinoma of Head and Neck

GALAXIES Lung-201 Interim Analysis: Belrestotug Plus Dostarlimab in Patients With PD-L1 High Non-Small Cell Lung Cancer (JSMO 2025) - No abstract available

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

iTeos Announces 2025 Strategic Priorities and Anticipated Milestones (GlobeNewswire) - "GALAXIES Lung-201: Topline interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, in first-line advanced / metastatic PD-L1 high NSCLC anticipated in 2Q25 to include safety, ORR, and ctDNA data from >240 patients, with pembrolizumab monotherapy ORR for 30 patients and PFS data from initial 124 patients treated. Data are expected to be submitted for presentation at a scientific congress in 2H 2025. GALAXIES H&N-202: Interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet and triplet with nelistotug in first-line patients with PD-L1 positive recurrent/metastatic HNSCC anticipated in 2025 to include safety and ORR from >150 patients."

P2 data • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

CDSCO Panel Approves GSK Protocol Amendment proposal for Belrestotug and Dostarlimab study (Medical Dialogues) - "The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major GSK's protocol amendment proposal for anticancer drug GSK4428859A (Belrestotug), GSK 4057190 (Dostarlimab) study. This came after the firm presented protocol amendment 2 dated 13 September 2024 protocol no.213823."

Clinical protocol • Non Small Cell Lung Cancer

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=176 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ May 2024 | Trial primary completion date: Jul 2025 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF

GALAXIES LUNG-201: A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) - P2 | N=340 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jan 2028 ➔ Oct 2028 | Trial primary completion date: Jan 2025 ➔ Oct 2025

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

iTeos Reports Third Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Program Highlights - Belrestotug (EOS-448/GSK4428859A):...(i) GALAXIES H&N-202: Interim data from randomized Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, versus dostarlimab in first-line patients with PD-L1 positive recurrent / metastatic HNSCC anticipated in 2025; (ii) TIG-006 HNSCC: Topline data from the first portion of TIG-006 study in cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in 2025."

P1/2 data • P2 data • Squamous Cell Carcinoma of Head and Neck