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<p>Neoadjuvant immunotherapy may improve long-term outcomes by activating antitumor immunity before surgery. We evaluated danburstotug (IMC-001), an anti–PD-L1 antibody, in resectable gastric cancer (GC), esophageal squamous cell carcinoma (ESCC), and hepatocellular carcinoma (HCC). In this phase II trial, patients received two cycles of danburstotug (20 mg/kg every 2 weeks) before surgery. The primary endpoint was major pathologic response (MPR, &lt;10% viable tumor). Key secondary endpoints included safety, radiologic/metabolic response, survival outcomes, and translational immune profiling. Forty-eight patients were evaluable (16 per cohort). The study did not meet its pre-specified primary endpoint, with MPR achieved in 2/48 patients (4.2%)—one ESCC and one HCC (6.3% per cohort). However, pathologic tumor regression to ≤50% viable tumor was observed in 11/48 patients (22.9%; GC 25.0%, ESCC 31.3%, HCC 12.5%). Among evaluable patients, partial responses were observed radiographically in 17.6% and metabolically in 23.3%. Treatment was well tolerated, with grade ≥3 treatment-related adverse events in 6.0% and no grade 4–5 events; two surgical delays were observed, of which one was treatment-related. All patients underwent surgery with R0 resection. Immune profiling revealed cancer type-specific immune-remodeling. Neoadjuvant danburstotug was safe, did not compromise surgical outcomes, and provided exploratory insights into treatment-induced immune microenvironment remodeling. ClinicalTrials.gov ID: NCT04196465, date of registration: August 28, 2019.</p>

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Neoadjuvant Danburstotug (IMC-001) therapy in gastric, esophageal, and hepatocellular carcinoma: the NeoChance phase II study

  • 期刊论文

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  • 发表日期：

    2026年7月3日

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  • Yeong Hak Bang,
  • Dawon Kang,
  • Seungwon Lee,
  • Seungsoo Kim,
  • Ina Jeon,
  • Eunjin Park,
  • Jungmin Choi,
  • Gi-Won Song,
  • Moon-Won Yoo,
  • Joon Seon Song,
  • In Hye Song,
  • Yong-Hee Kim,
  • Hyeong Ryul Kim,
  • Ho June Song,
  • Do Hoon Kim,
  • Kee Don Choi,
  • Jeong Hoon Lee,
  • Ji Yong Ahn,
  • Ju Hyun Shim,
  • Danbi Lee,
  • Jonggi Choi,
  • Ji Eun Kim,
  • Sang-Yeob Kim,
  • Dong-Jun Bae,
  • Sook Ryun Park

摘要

Neoadjuvant immunotherapy may improve long-term outcomes by activating antitumor immunity before surgery. We evaluated danburstotug (IMC-001), an anti–PD-L1 antibody, in resectable gastric cancer (GC), esophageal squamous cell carcinoma (ESCC), and hepatocellular carcinoma (HCC). In this phase II trial, patients received two cycles of danburstotug (20 mg/kg every 2 weeks) before surgery. The primary endpoint was major pathologic response (MPR, <10% viable tumor). Key secondary endpoints included safety, radiologic/metabolic response, survival outcomes, and translational immune profiling. Forty-eight patients were evaluable (16 per cohort). The study did not meet its pre-specified primary endpoint, with MPR achieved in 2/48 patients (4.2%)—one ESCC and one HCC (6.3% per cohort). However, pathologic tumor regression to ≤50% viable tumor was observed in 11/48 patients (22.9%; GC 25.0%, ESCC 31.3%, HCC 12.5%). Among evaluable patients, partial responses were observed radiographically in 17.6% and metabolically in 23.3%. Treatment was well tolerated, with grade ≥3 treatment-related adverse events in 6.0% and no grade 4–5 events; two surgical delays were observed, of which one was treatment-related. All patients underwent surgery with R0 resection. Immune profiling revealed cancer type-specific immune-remodeling. Neoadjuvant danburstotug was safe, did not compromise surgical outcomes, and provided exploratory insights into treatment-induced immune microenvironment remodeling. ClinicalTrials.gov ID: NCT04196465, date of registration: August 28, 2019.