Neoadjuvant Danburstotug (IMC-001) therapy in gastric, esophageal, and hepatocellular carcinoma: the NeoChance phase II study
11 affiliations
- 1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
- 2Department of Biomedical Sciences, Korea University College of Medicine, Seoul, Republic of Korea
- 3BK21 Graduate Program, Department of Biomedical Sciences, Korea University College of Medicine, Seoul, Republic of Korea
- 4Department of Liver Transplantation and Hepatobiliary Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
- 5Department of Stomach Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
- 6Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
- 7Department of Thoracic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
- 8Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
- 9Biomedical Research Center, Asan Medical Center, Seoul, Republic of Korea
- 10Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea
- 11PrismCDX Co., Ltd., Hwaseong-si, Gyeonggi-do, Republic of Korea
Abstract
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.
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BibTeX
@article{bang2026neoadjuvant,
title = {{Neoadjuvant Danburstotug (IMC-001) therapy in gastric, esophageal, and hepatocellular carcinoma: the NeoChance phase II study}},
author = {Yeong Hak Bang and Dawon Kang and Seungwon Lee and Seungsoo Kim and Ina Jeon and Eunjin Park and Jungmin Choi and Gi-Won Song and Moon-Won Yoo and Joon Seon Song and In Hye Song and Yong-Hee Kim and Hyeong Ryul Kim and Ho June Song and Do Hoon Kim and Kee Don Choi and Jeong Hoon Lee and Ji Yong Ahn and Ju Hyun Shim and Danbi Lee and Jonggi Choi and Ji Eun Kim and Sang-Yeob Kim and Dong-Jun Bae and Sook Ryun Park},
journal = {NPJ Precision Oncology},
year = {2026},
month = jul,
doi = {10.1038/s41698-026-01571-2},
url = {https://doi.org/10.1038/s41698-026-01571-2},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Neoadjuvant Danburstotug (IMC-001) therapy in gastric, esophageal, and hepatocellular carcinoma: the NeoChance phase II study
AU - Yeong Hak Bang
AU - Dawon Kang
AU - Seungwon Lee
AU - Seungsoo Kim
AU - Ina Jeon
AU - Eunjin Park
AU - Jungmin Choi
AU - Gi-Won Song
AU - Moon-Won Yoo
AU - Joon Seon Song
AU - In Hye Song
AU - Yong-Hee Kim
AU - Hyeong Ryul Kim
AU - Ho June Song
AU - Do Hoon Kim
AU - Kee Don Choi
AU - Jeong Hoon Lee
AU - Ji Yong Ahn
AU - Ju Hyun Shim
AU - Danbi Lee
AU - Jonggi Choi
AU - Ji Eun Kim
AU - Sang-Yeob Kim
AU - Dong-Jun Bae
AU - Sook Ryun Park
PY - 2026
DA - 2026/07/03
JO - NPJ Precision Oncology
DO - 10.1038/s41698-026-01571-2
UR - https://doi.org/10.1038/s41698-026-01571-2
AB - 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.
SN - 2397-768X
ER -