nelistotug (GSK6097608) / GSK, 23andMe - LARVOL DELTA

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

GSK abandons hopes for CD226 cancer therapies, dropping remaining phase 2 assets (FierceBiotech) - "One of these is nelistotug, also known as GSK6097608...The other nail in GSK’s CD226 coffin is the pharma’s decision to halt work on its anti-PVRIG antibody GSK4381562....GSK has given up on its CD226 dream..."

Discontinued • Breast Cancer • Clear Cell Renal Cell Carcinoma • Endometrial Cancer • Gastric Cancer • Non Small Cell Lung Cancer • 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-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 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

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

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=141 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Oct 2026 ➔ Sep 2028 | Trial primary completion date: Oct 2026 ➔ Sep 2028

Combination therapy • Metastases • 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

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=360 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Aug 2027 ➔ May 2027 | Trial primary completion date: Sep 2025 ➔ May 2027

Metastases • 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

Phase 2 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 (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2027 ➔ Aug 2027 | Trial primary completion date: Mar 2027 ➔ Sep 2025

Enrollment open • Metastases • 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

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Mar 2026 ➔ Jan 2028

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

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=244 | Recruiting | Sponsor: GlaxoSmithKline | N=184 ➔ 244 | Trial completion date: Jul 2024 ➔ Sep 2025 | Trial primary completion date: Jul 2024 ➔ Sep 2025

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Phase 2 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 (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Dec 2025 ➔ Mar 2027 | Trial primary completion date: Sep 2025 ➔ Mar 2027

Metastases • 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

Phase 2 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 (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: GlaxoSmithKline

Metastases • New P2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Oct 2024 ➔ Jan 2025

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

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=184 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Apr 2025 ➔ Jul 2024 | Trial primary completion date: Apr 2025 ➔ Jul 2024

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=184 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Aug 2024 ➔ Apr 2025 | Trial primary completion date: Aug 2024 ➔ Apr 2025

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase II study of anti-TIGIT GSK4428859A (GSK’859A)/EOS-448 + anti-CD96 GSK6097608 (GSK’608) + anti-PD-1 dostarlimab in non-small cell lung cancer (NSCLC) (ESMO 2022) - P1, P1/2, P2 | "Patients will receive IV GSK'859A/EOS-448 + dostarlimab + GSK'608 (dose escalation) q3w for ≤35 cycles or 2 years or until disease progression, consent withdrawal, intolerability, or death. Part 1 endpoints are safety and tolerability (primary) and efficacy and pharmacokinetics (secondary)."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD96 • NECTIN2 • PVR • TIGIT