Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Rilvegostomig for Metastatic Non-Small-Cell Lung Cancer: A First-In-Human Phase I/II Clinical Study.
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Rohrberg Kristoffer S, Brandão Mariana, Castañón Álvarez Eduardo, Felip Enriqueta, Gort Eelke, Hiltermann T Jeroen N, Izumi Hiroki, Kim Dong-Wan, Kim Sang-We, Paz-Ares Luis, Solomon Benjamin, Smit Egbert F, Wauters Els, Yoshida Tatsuya, Ayyoub Amal, Chen Huifang Ariel, Colebrook Steve, Hamidi Negar Nikki, Kuziora Michael, Lim KyoungSoo, Achour Ikbel, Drachsler Moritz W, Karanovic Djuro, Liu Nelson, Cho Byoung Chul
Аннотация
PURPOSE: Rilvegostomig, an anti-PD-1/TIGIT bispecific antibody, was evaluated in this first-in-human, multicenter, phase I/II, open-label study (NCT04995523) in checkpoint inhibitor (CPI)-experienced patients with programmed death ligand-1 (PD-L1)-positive advanced or metastatic non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS: In Part A, patients (n = 51) received intravenous rilvegostomig at escalating doses of 70, 210, 750, and 1500 mg, once every 3 weeks (Q3W). Dose expansion in Part B (n = 32) was initiated once the recommended phase II dose (RP2D) was declared in Part A. Safety, tolerability, pharmacodynamics, pharmacokinetics and preliminary antitumor activity were evaluated.
RESULTS: In Part A no dose-limiting toxicities were observed, the maximum tolerated dose was not reached and the rilvegostomig RP2D for dose expansion in Part B was 750 mg Q3W. At data cut-off (April 21, 2025), 90.4% of patients had treatment-emergent adverse events (TEAEs) of any grade, 18.1% of patients had investigator-assessed immune-mediated AEs, and 54.2% had treatment-related AEs (TRAEs), including 8.4% with grade 3 TRAEs, with few treatment-related discontinuations (2.4%). At the RP2D, objective response rate was 5.6%, 6-month disease control rate was 31.5%, median progression-free survival (PFS) was 3.8 months, and 12-month PFS was 11.9%.
CONCLUSIONS: The evidence of clinical efficacy in a pretreated population, favorable tolerability and low rate of treatment discontinuation observed in Parts A and B support further evaluation of rilvegostomig in Parts C-E of the study, which assess safety and efficacy in CPI-naïve patients with nonsquamous and/or squamous NSCLC with PD-L1 tumor proportion score ≥1% or ≥50%.
PATIENTS AND METHODS: In Part A, patients (n = 51) received intravenous rilvegostomig at escalating doses of 70, 210, 750, and 1500 mg, once every 3 weeks (Q3W). Dose expansion in Part B (n = 32) was initiated once the recommended phase II dose (RP2D) was declared in Part A. Safety, tolerability, pharmacodynamics, pharmacokinetics and preliminary antitumor activity were evaluated.
RESULTS: In Part A no dose-limiting toxicities were observed, the maximum tolerated dose was not reached and the rilvegostomig RP2D for dose expansion in Part B was 750 mg Q3W. At data cut-off (April 21, 2025), 90.4% of patients had treatment-emergent adverse events (TEAEs) of any grade, 18.1% of patients had investigator-assessed immune-mediated AEs, and 54.2% had treatment-related AEs (TRAEs), including 8.4% with grade 3 TRAEs, with few treatment-related discontinuations (2.4%). At the RP2D, objective response rate was 5.6%, 6-month disease control rate was 31.5%, median progression-free survival (PFS) was 3.8 months, and 12-month PFS was 11.9%.
CONCLUSIONS: The evidence of clinical efficacy in a pretreated population, favorable tolerability and low rate of treatment discontinuation observed in Parts A and B support further evaluation of rilvegostomig in Parts C-E of the study, which assess safety and efficacy in CPI-naïve patients with nonsquamous and/or squamous NSCLC with PD-L1 tumor proportion score ≥1% or ≥50%.