Pneumologie 2025; 79(S 01): S46-S47
DOI: 10.1055/s-0045-1804639
Abstracts
B1 – Pneumologische Onkologie

Interim Analysis of GALAXIES Lung-201: Phase 2, 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)

M Thomas
1   University Hospital Heidelberg; Thoraxklinik at Heidelberg; Department of Thoracic Oncology
,
D Spigel
2   Sarah Cannon Research Institute; Medical Oncology,
,
E Korbenfeld
3   Hospital Británico de Buenos Aires; Medical Oncology
,
H Hayashi
4   Kindai University Faculty of Medicine; Department of Medical Oncology
,
R Corre
5   Service de Pneumologie, Ch Quimper,
,
B Cho
6   Yonsei Cancer Center, Yonsei University College of Medicine,; Division of Medical Oncology,
,
A Psyrri
7   National and Kapodistrian University of Athens, Attikon University Hospital,; Section of Medical Oncology,
,
M Cobo Dols
8   University Hospital Regional Málaga; Regional and Virgen de la Victoria University Hospitals; Medical Oncology Intercenter Unit,
,
E Parkhomenko
9   Development Biostatistics, Gsk,
,
D Baxter
10   Oncology Clinical Development, Gsk,
,
N Patel
10   Oncology Clinical Development, Gsk,
,
F Trinchese
11   Oncology Clinical Development, Gsk
,
I Diaz-Padilla
10   Oncology Clinical Development, Gsk,
,
M Reck
12   Lungenclinic Grosshansdorf, Airway Research Center North (Arcn), Member of the German Center for Lung Research (Dzl); Onkologischer Schwerpunkt, Lungenclinic Grosshansdorf, Großhansdorf; Airway Research Center North (Arcn), Deutsches Zentrum für Lungenforschung (Dzl)
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Background: Less than 50% of pts with unresectable LA/M PD-L1 high NSCLC respond to 1L immunotherapy (IO) necessitating new treatment approaches [1] [2] [3]]. GALAXIES Lung-201 (NCT05565378) is a Phase 2, open-label, randomized platform study evaluating novel IO combinations including belrestotug (anti-TIGIT)+dostarlimab (anti–PD-1) in previously untreated PD-L1 high LA/M NSCLC.

Methods: Pts with previously untreated, unresectable, PD-L1 high (tumor positive score [TPS]≥50% confirmed locally or centrally via DAKO 22C3 [local only] or VENTANA SP263) LA/M NSCLC with no actionable mutations were randomized to dostarlimab 500 mg alone or with belrestotug (Substudy 1) at 100 mg (A), 400 mg (B) or 1000 mg (C) every 3 weeks until disease progression, intolerable toxicity or death. The primary endpoint is objective response rate (ORR) per RECIST 1.1 by investigator assessment.

Results: At data cut off, 32, 30, 32 and 30 pts in dostarlimab, A, B and C were included in this follow up (FU) interim analysis (IA) of preliminary efficacy and safety (modified intent-to-treat population defined as≥5.6 months FU). Median overall FU was 7.3 months and 65% of pts remain ongoing. A, B and C had greater ORR and a higher incidence of Grade (Gr) 3+treatment related adverse events (TRAEs), which were considered manageable, vs dostarlimab ([Fig. 1]).

Zoom Image
Fig. 1  

Conclusions: At this IA, belrestotug+dostarlimab demonstrated clinically meaningful anti-tumor activity at each dose and a manageable safety profile, supporting further evaluation in a phase 3 study (NCT06472076) in pts with previously untreated, unresectable LA/M PD-L1 high NSCLC.



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Artikel online veröffentlicht:
18. März 2025

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