A phase II trial of tobemstomig (tobe) plus platinum-based chemotherapy (chemo) vs pembrolizumab (pembro) plus chemo in patients (pts) with untreated locally advanced or metastatic non-small cell lung cancer (NSCLC)
Recommended Citation
Nadal E, Rittmeyer A, De Marinis F, Lee DH, Gadgeel SM, Vilariño N, Bria E, Arulananda S, Cronenberg EH, Antic V, Bennett E, Hu Y, Madden-Raja K, Williams P, Prizant H, Popat S. A phase II trial of tobemstomig (tobe) plus platinum-based chemotherapy (chemo) vs pembrolizumab (pembro) plus chemo in patients (pts) with untreated locally advanced or metastatic non-small cell lung cancer (NSCLC). 2025; (3 suppl 1):S11-S12.
Document Type
Conference Proceeding
Publication Date
3-1-2025
Abstract
Background: Tobemstomig (tobe) is a novel bispecific antibody targeting programmed death-1 (PD-1) and lymphocyte-activation gene 3 (LAG-3). BO44178 (NCT05775289) is a randomised, double-blind, phase II study evaluating tobe + chemo vs pembro + chemo in pts with NSCLC who are ineligible for surgery or definitive chemoradiotherapy. Methods: Eligible pts with previously untreated, locally advanced unresectable or metastatic NSCLC were randomised 1:1 to receive either induction tobe + chemo (carboplatin + paclitaxel/pemetrexed) or pembro + chemo for four 21-day cycles, followed by maintenance tobe or pembro with/without pemetrexed every 3 weeks until disease progression, toxicity or loss of clinical benefit. Pts were stratified by PD ligand 1 expression, histology and smoking status. Primary endpoints: confirmed objective response rate (ORR); progression-free survival (PFS). Secondary endpoints included overall survival (OS), duration of response (DoR) and safety. Results: At data cutoff (20 June 2024), 181 pts were randomised to receive tobe + chemo (n = 90) or pembro + chemo (n = 91). Median duration of follow-up was 6 months. Baseline characteristics were similar across treatment arms; median age was 66 years. There was no improvement in confirmed ORR with tobe + chemo (41.1%) vs pembro + chemo (46.2%) and no PFS difference was observed between treatment arms (HR 0.99; 95% CI 0.63, 1.56; Table). OS data were immature at this analysis. Efficacy results were consistent across subgroups. The rates of grade 3/4 adverse events (AEs), serious AEs and immune-mediated AEs were higher with tobe + chemo vs pembro + chemo; however, the rate of treatment withdrawal due to AEs was similar between arms. Conclusions: At this interim analysis, no ORR or PFS benefit was observed in pts with untreated locally advanced or metastatic NSCLC receiving tobe + chemo over pembro + chemo. OS data remain immature.
Issue
3 suppl 1
First Page
S11
Last Page
S12
