belrestotug (EOS-448) / iTeos, GSK - LARVOL DELTA

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

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

iTeos Reports Third Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Program Highlights - Belrestotug (EOS-448/GSK4428859A):...(i) GALAXIES Lung-301: Enrollment ongoing globally in randomized, double-blind Phase 3 registrational study assessing belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC. EMA granted clearance to advance belrestotug 400mg + dostarlimab as the recommended Phase 3 dose, allowing for the activation of clinical sites in the EU First patient first dose achieved in the EU; (ii) GALAXIES Lung-201: Further interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet in first-line advanced / metastatic PD-L1 high NSCLC anticipated in 2025."

P2 data • Trial status • Non Small Cell Lung Cancer

Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=16 | Terminated | Sponsor: iTeos Therapeutics | Phase classification: P1/2 ➔ P1

Combination therapy • Phase classification • Hematological Malignancies • Multiple Myeloma • Oncology

Comment: Trial updates from GALAXIES Lung-201 and RELATIVITY-104 in NSCLC (ecancer) - "Dr Marina Garassino comments on the interim analysis of GALAXIES Lung-201 and the results from the randomized phase II RELATIVITY-104 study....Dr Garassino comments that in this interim analysis, belrestotug and dostarlimab demonstrat clinically meaningful anti-tumour activity at each dose and a manageable safety profile, supporting further evaluation in patients with previously untreated, unresectable LA/M PD-L1 high NSCLC."

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First-In-Human Study of EOS884448 in Participants with Advanced Cancers. (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: iTeos Therapeutics | Phase classification: P1/2 ➔ P1

Phase classification • Oncology

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

Frontline Belrestotug/Dostarlimab Boosts Responses Vs Dostarlimab Alone in PD-L1–High NSCLC (OncLive) - "'GALAXIES-Lung 201 is the largest, prospectively designed, randomized, dose-ranging, phase 2 study in patients with newly diagnosed PD-L1–high NSCLC, looking at a combination of an anti-TIGIT and anti–PD-1 regimen,' David R. Spigel, MD...said in a presentation of the data. 'A clinically meaningful improvement in ORR was seen in all combination cohorts compared with the dostarlimab monotherapy. This combination regimen had an increase in immune-related adverse effects [AEs], but these were largely considered generally manageable. Ongoing recruitment in the reported arms and additional follow-up will better characterize the efficacy and safety of this combination regimen.'"

Media quote

iTeos Announces Clinically Meaningful Objective Response Rate Observed at Every Dose in Follow-up Interim Analysis of GALAXIES Lung-201 Study of Belrestotug + Dostarlimab in First-Line, PD-L1 High Non-Small Cell Lung Cancer Patients (GlobeNewswire) - P2 | N=300 | GALAXIES LUNG-201 (NCT05565378) | Sponsor: GlaxoSmithKline | "...We...are excited to see longer-term follow-up data in 2025'....As of the June 7, 2024 data cutoff, the late-breaking interim data presented at the ESMO Congress were based on 124 patients eligible for safety and efficacy evaluation (modified intention-to-treat ≥5.6 months follow-up)....Clinically meaningful improvement in the primary endpoint of ORR was observed consistently across each belrestotug + dostarlimab cohort (63.3% Dose A, 65.6% Dose B and 76.7% Dose C compared to 37.5% with dostarlimab alone). cORR, defined as complete or partial response confirmed by repeat imaging ≥4 weeks after response criteria first met, was roughly 60.0% for each dose compared to 28.1% cORR for dostarlimab alone. Of the patients with evaluable paired ctDNA samples (baseline and week 7), median ctDNA reduction was 65% for dostarlimab monotherapy compared to 55% for Dose A, 94% for Dose B, and 97% for Dose C."

Late-breaking abstract • P2 data • Non Small Cell Lung Cancer

iTeos Therapeutics Announces Late-Breaking Oral Presentation of Phase 2 GALAXIES Lung-201 Interim Data at the European Society for Medical Oncology Congress 2024 (GlobeNewswire) - "iTeos Therapeutics, Inc...today announced that interim data from GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos’ development partner GSK, assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer, will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024, being held September 13-17, 2024 in Barcelona, Spain."

Late-breaking abstract • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

iTeos Reports Second Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Program Highlights - Belrestotug (EOS-448/GSK4428859A):...(i) GALAXIES Lung-201: Interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet in first-line advanced / metastatic PD-L1 high NSCLC anticipated in second half of 2024....(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 second half 2024."

P1/2 data • P2 data • Non Small Cell Lung Cancer • 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

GSK Pharma India Gets CDSCO Panel Nod for phase 3 CT of Belrestotug and Dostarlimab (Medical Dialogues) - "The drug major GSK Pharma India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the phase 3 clinical trial of the anti-cancer drug GSK4428859A (Belrestotug) and GSK4057190 (Dostarlimab). This came after GSK Pharma India presented phase 3 clinical study protocol no. 213823 dated 09 January 2024....At the recent SEC meeting for oncology held on July 9, 2024, the expert panel reviewed phase 3 clinical study protocol no. 213823 dated 09 January 2024, presented by GSK Pharma India. After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor