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Войти в исследования Targeted oncology · 2026
Vibostolimab Coformulated with Pembrolizumab Plus Chemotherapy as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer.
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Sands Jacob, Lu Shun, Aerts Joachim G, Reck Martin, Navarro Alejandro, Shentzer Kutiel Talia, Peled Nir, Casarini Ignacio, Kerr Samuel J, Takahashi Toshiaki, Bilici Ahmet, Cheng Ying, Wang Mengzhao, Lee Shin Yup, Łowczak Anna, Mazieres Julien, Hu Haixia, Wu Jianyu, Aggarwal Himani, El-Osta Hazem, Paz-Ares Luis
Аннотация
BACKGROUND: Vibostolimab, an anti-T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) antibody, showed antitumor activity with pembrolizumab in non-small-cell lung cancer.
OBJECTIVE: The KEYVIBE-008 study evaluated vibostolimab coformulated with pembrolizumab (vibostolimab/pembrolizumab) plus etoposide and platinum-based chemotherapy (EP) versus atezolizumab plus EP as first-line therapy for extensive-stage small-cell lung cancer.
METHODS: Participants aged ≥18 years with untreated extensive-stage small-cell lung cancer were randomized 1:1 to vibostolimab/pembrolizumab (200 mg each) or atezolizumab (1200 mg) every 3 weeks, with EP and cisplatin/carboplatin for the first four cycles. The primary endpoint was overall survival. The prespecified interim analysis included a non-binding futility analysis of overall survival (futility threshold for actual number of events, P = 0.4816).
RESULTS: Four hundred and sixty participants were randomized (both arms, n = 230). Median time from randomization to data cutoff (4 June, 2024) was 16.6 (range 11.3‒26.1) months. The prespecified futility criterion for overall survival was met (hazard ratio 1.26; 95% confidence interval 1.00‒1.59; P = 0.9762). There was no difference in progression-free survival (hazard ratio 1.01; 95% confidence interval 0.82‒1.23) or objective response rates (71.7% with vibostolimab/pembrolizumab vs 74.8% with atezolizumab). Grade ≥3 treatment-related adverse events occurred in 66.8% of participants treated with vibostolimab/pembrolizumab and 57.2% treated with atezolizumab. Immune-mediated adverse events and infusion reactions occurred in 39.3% and 29.7% of participants, respectively.
CONCLUSIONS: In this interim analysis of vibostolimab/pembrolizumab plus EP versus atezolizumab plus EP as first-line therapy for extensive-stage small-cell lung cancer, the prespecified futility criterion for overall survival was met. Grade ≥3 treatment-related adverse events and immune-mediated adverse events were more frequent with vibostolimab/pembrolizumab versus atezolizumab. Given the overall benefit/risk profile, treatment with vibostolimab/pembrolizumab was discontinued.
CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT05224141.
OBJECTIVE: The KEYVIBE-008 study evaluated vibostolimab coformulated with pembrolizumab (vibostolimab/pembrolizumab) plus etoposide and platinum-based chemotherapy (EP) versus atezolizumab plus EP as first-line therapy for extensive-stage small-cell lung cancer.
METHODS: Participants aged ≥18 years with untreated extensive-stage small-cell lung cancer were randomized 1:1 to vibostolimab/pembrolizumab (200 mg each) or atezolizumab (1200 mg) every 3 weeks, with EP and cisplatin/carboplatin for the first four cycles. The primary endpoint was overall survival. The prespecified interim analysis included a non-binding futility analysis of overall survival (futility threshold for actual number of events, P = 0.4816).
RESULTS: Four hundred and sixty participants were randomized (both arms, n = 230). Median time from randomization to data cutoff (4 June, 2024) was 16.6 (range 11.3‒26.1) months. The prespecified futility criterion for overall survival was met (hazard ratio 1.26; 95% confidence interval 1.00‒1.59; P = 0.9762). There was no difference in progression-free survival (hazard ratio 1.01; 95% confidence interval 0.82‒1.23) or objective response rates (71.7% with vibostolimab/pembrolizumab vs 74.8% with atezolizumab). Grade ≥3 treatment-related adverse events occurred in 66.8% of participants treated with vibostolimab/pembrolizumab and 57.2% treated with atezolizumab. Immune-mediated adverse events and infusion reactions occurred in 39.3% and 29.7% of participants, respectively.
CONCLUSIONS: In this interim analysis of vibostolimab/pembrolizumab plus EP versus atezolizumab plus EP as first-line therapy for extensive-stage small-cell lung cancer, the prespecified futility criterion for overall survival was met. Grade ≥3 treatment-related adverse events and immune-mediated adverse events were more frequent with vibostolimab/pembrolizumab versus atezolizumab. Given the overall benefit/risk profile, treatment with vibostolimab/pembrolizumab was discontinued.
CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT05224141.