A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12)
Spartalizumab (PDR001) is a humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We conducted a single-arm, phase 2 trial to investigate the efficacy and safety of spartalizumab in patients with refractory esophageal squamous cell carcinoma (ESCC). Patients with histo...
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Taylor & Francis Group
2024-12-01
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| Series: | OncoImmunology |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/2162402X.2024.2371563 |
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| author | Dong Ki Lee Sook Ryun Park Yeul Hong Kim Yun-Gyoo Lee Su-Jin Shin Beung-Chul Ahn Sung Sook Lee Sun Min Lim Hye Ryun Kim Byoung Chul Cho Min Hee Hong |
| author_facet | Dong Ki Lee Sook Ryun Park Yeul Hong Kim Yun-Gyoo Lee Su-Jin Shin Beung-Chul Ahn Sung Sook Lee Sun Min Lim Hye Ryun Kim Byoung Chul Cho Min Hee Hong |
| author_sort | Dong Ki Lee |
| collection | DOAJ |
| description | Spartalizumab (PDR001) is a humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We conducted a single-arm, phase 2 trial to investigate the efficacy and safety of spartalizumab in patients with refractory esophageal squamous cell carcinoma (ESCC). Patients with histologically confirmed ESCC who experienced disease progression after platinum-based chemotherapy received 300 mg of intravenous spartalizumab every three weeks until disease progression or occurrence of unacceptable toxicity. The primary endpoint was centrally assessed objective response according to the Response Evaluation Criteria in Solid Tumors, version 1.1. Adverse events were closely monitored throughout the study. From March 2020 through April 2021, 44 patients with ESCC were enrolled. Of the 44 patients, the objective response rate was 20.5% (95% confidence interval: 8.5–32.4). With a median follow-up of 10.9 months, median progression-free survival and overall survival were 3.2 months and 11.2 months, respectively. In addition, the median duration of response was 24.7 months. The most common grade 3 or 4 adverse event was grade 3 dysphagia (eight [18%] patients). Biomarker analyses explored programmed cell death ligand 1 and CD20 as potential predictive markers for PD-1 blockade. Spartalizumab showed promising activity with a manageable safety profile, indicating its potential as a new treatment option for patients with refractory ESCC.Trial registration The trial was registered at ClinicalTrials.gov under the identifier NCT03785496. |
| format | Article |
| id | doaj-art-7b1070c787db4a9e95ccef4e55841573 |
| institution | Kabale University |
| issn | 2162-402X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | OncoImmunology |
| spelling | doaj-art-7b1070c787db4a9e95ccef4e558415732024-12-03T13:49:34ZengTaylor & Francis GroupOncoImmunology2162-402X2024-12-0113110.1080/2162402X.2024.2371563A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12)Dong Ki Lee0Sook Ryun Park1Yeul Hong Kim2Yun-Gyoo Lee3Su-Jin Shin4Beung-Chul Ahn5Sung Sook Lee6Sun Min Lim7Hye Ryun Kim8Byoung Chul Cho9Min Hee Hong10Department of Pharmacology, Yonsei University College of Medicine, Seoul, KoreaDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDivision of Medical Oncology, Department of Internal Medicine, Korea University College of Medicine, Seoul, KoreaDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, KoreaDepartment of Pathology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, KoreaCenter for Lung Cancer, National Cancer Center, Goyang-si, South KoreaInje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, South KoreaDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, KoreaDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, KoreaDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, KoreaDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, KoreaSpartalizumab (PDR001) is a humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We conducted a single-arm, phase 2 trial to investigate the efficacy and safety of spartalizumab in patients with refractory esophageal squamous cell carcinoma (ESCC). Patients with histologically confirmed ESCC who experienced disease progression after platinum-based chemotherapy received 300 mg of intravenous spartalizumab every three weeks until disease progression or occurrence of unacceptable toxicity. The primary endpoint was centrally assessed objective response according to the Response Evaluation Criteria in Solid Tumors, version 1.1. Adverse events were closely monitored throughout the study. From March 2020 through April 2021, 44 patients with ESCC were enrolled. Of the 44 patients, the objective response rate was 20.5% (95% confidence interval: 8.5–32.4). With a median follow-up of 10.9 months, median progression-free survival and overall survival were 3.2 months and 11.2 months, respectively. In addition, the median duration of response was 24.7 months. The most common grade 3 or 4 adverse event was grade 3 dysphagia (eight [18%] patients). Biomarker analyses explored programmed cell death ligand 1 and CD20 as potential predictive markers for PD-1 blockade. Spartalizumab showed promising activity with a manageable safety profile, indicating its potential as a new treatment option for patients with refractory ESCC.Trial registration The trial was registered at ClinicalTrials.gov under the identifier NCT03785496.https://www.tandfonline.com/doi/10.1080/2162402X.2024.2371563CD20-positive immune cellEsophageal squamous cell carcinomaimmune checkpoint inhibitorPD-L1 expressionspartalizumab |
| spellingShingle | Dong Ki Lee Sook Ryun Park Yeul Hong Kim Yun-Gyoo Lee Su-Jin Shin Beung-Chul Ahn Sung Sook Lee Sun Min Lim Hye Ryun Kim Byoung Chul Cho Min Hee Hong A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12) OncoImmunology CD20-positive immune cell Esophageal squamous cell carcinoma immune checkpoint inhibitor PD-L1 expression spartalizumab |
| title | A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12) |
| title_full | A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12) |
| title_fullStr | A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12) |
| title_full_unstemmed | A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12) |
| title_short | A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12) |
| title_sort | phase 2 study of spartalizumab pdr001 among patients with recurrent or metastatic esophageal squamous cell carcinoma kcsg hn18 17 k master project 12 |
| topic | CD20-positive immune cell Esophageal squamous cell carcinoma immune checkpoint inhibitor PD-L1 expression spartalizumab |
| url | https://www.tandfonline.com/doi/10.1080/2162402X.2024.2371563 |
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