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Objective <p>To evaluate the efficacy and safety of the anti-lymphocyte activation gene-3 (LAG-3) antibody IBI110 in combination with sintilimab and chemotherapy in patients with advanced squamous non-small cell lung cancer (sqNSCLC).</p> Methods <p>In this multicenter, randomized, open-label, phase II study, 153 patients with previously untreated advanced sqNSCLC were randomly assigned at a 1:1:1 ratio to one of three groups: IBI110 200&#xa0;mg plus sintilimab (200&#xa0;mg) and chemotherapy (n = 51), IBI110 600&#xa0;mg plus sintilimab and chemotherapy (n = 51), or sintilimab plus chemotherapy (standard-of-care, SOC, n = 51). The primary endpoints included the objective response rate (ORR), progression-free survival (PFS) and safety. LAG-3 expression in tumor tissue was detected by immunohistochemistry (IHC) to explore its correlation with treatment efficacy.</p> Results <p>While no statistically significant differences in ORR, PFS, or overall survival (OS) were observed across the three arms in the overall population, promising efficacy signals emerged in the LAG-3 expression ≥ 2% subgroup. In this subset, compared with the SOC regimen, the IBI110 200&#xa0;mg regimen significantly improved the duration of response (DOR: 13.73 vs. 6.51&#xa0;months, <i>P</i> = 0.037) and PFS (<i>P</i> = 0.0485). The safety results indicated that the IBI110 200&#xa0;mg combination was manageable, with a higher incidence of grade ≥ 3 treatment-related adverse events (56.86% vs. 29.41%) primarily consisting of controllable hematological toxicities.</p> Conclusion <p>The high-LAG-3 subgroup demonstrated enhanced efficacy following the addition of IBI110 to sintilimab and chemotherapy, despite the absence of improvement in the overall population with advanced sqNSCLC, supporting further investigations in biomarker-defined patients.</p> Trial registration <p>The current study has been registered with ClinicalTrial.gov (Identifier: NCT04085185).</p>

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Efficacy and safety of anti-LAG-3 IBI110 in combination with sintilimab and chemotherapy for advanced squamous non-small cell lung cancer: a randomized phase II study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月27日

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  • Qianyi Wang,
  • Anwen Xiong,
  • Chenyu Mao,
  • Wenxiang Wang,
  • Jiuwei Cui,
  • Jian Fang,
  • Wu Zhuang,
  • Kunyu Yang,
  • Wei Zuo,
  • Jun Yang,
  • Lika Ye,
  • Zhiye Zhang,
  • Zengmei Sheng,
  • Zhe Liu,
  • Donglin Wang,
  • Xiaobo Du,
  • Tienan Yi,
  • Sixiang Long,
  • Nong Xu,
  • Caicun Zhou

摘要

Objective

To evaluate the efficacy and safety of the anti-lymphocyte activation gene-3 (LAG-3) antibody IBI110 in combination with sintilimab and chemotherapy in patients with advanced squamous non-small cell lung cancer (sqNSCLC).

Methods

In this multicenter, randomized, open-label, phase II study, 153 patients with previously untreated advanced sqNSCLC were randomly assigned at a 1:1:1 ratio to one of three groups: IBI110 200 mg plus sintilimab (200 mg) and chemotherapy (n = 51), IBI110 600 mg plus sintilimab and chemotherapy (n = 51), or sintilimab plus chemotherapy (standard-of-care, SOC, n = 51). The primary endpoints included the objective response rate (ORR), progression-free survival (PFS) and safety. LAG-3 expression in tumor tissue was detected by immunohistochemistry (IHC) to explore its correlation with treatment efficacy.

Results

While no statistically significant differences in ORR, PFS, or overall survival (OS) were observed across the three arms in the overall population, promising efficacy signals emerged in the LAG-3 expression ≥ 2% subgroup. In this subset, compared with the SOC regimen, the IBI110 200 mg regimen significantly improved the duration of response (DOR: 13.73 vs. 6.51 months, P = 0.037) and PFS (P = 0.0485). The safety results indicated that the IBI110 200 mg combination was manageable, with a higher incidence of grade ≥ 3 treatment-related adverse events (56.86% vs. 29.41%) primarily consisting of controllable hematological toxicities.

Conclusion

The high-LAG-3 subgroup demonstrated enhanced efficacy following the addition of IBI110 to sintilimab and chemotherapy, despite the absence of improvement in the overall population with advanced sqNSCLC, supporting further investigations in biomarker-defined patients.

Trial registration

The current study has been registered with ClinicalTrial.gov (Identifier: NCT04085185).