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Original Article
- Zolbetuximab Plus Chemotherapy as First-Line Treatment in Patients with Claudin 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: Korean Population Subgroup—Combined Efficacy and Safety Analysis from SPOTLIGHT and GLOW
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Keun-Wook Lee1
, Sang Cheul Oh2, Jong Gwang Kim3, Sun Jin Sym4, Byoung Yong Shim5, Seok Yun Kang6, In-Ho Kim7, Jwa Hoon Kim8, Hong Jae Chon9, Sang-Hee Cho10, Eun-Kee Song11, Do-Youn Oh12,13, Jin-Soo Kim14, Young Iee Park15, Won Ki Kang16, Hyung-Don Kim17, Janise Lee18, Miri Yi19, Min-Hee Ryu17
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DOI: https://doi.org/10.4143/crt.2025.935 [Accepted]
Published online: December 5, 2025
1Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
2Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea
3Department of Oncology/Hematology, Kyungpook National University Chilgok Hospital, Daegu, Korea
4Department of Medical Oncology, Gachon University Gil Medical Center, Incheon, Korea
5Division of Medical Oncology, Department of Internal Medicine, The Catholic University of Korea St. Vincent's Hospital, Suwon, Korea
6Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea
7Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
8Division of Medical Oncology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea
9Department of Medical Oncology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea
10Division of Hemato-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea
11Division of Oncology and Hematology, Department of Internal Medicine, Jeonbuk National University Hospital, Jeonbuk National University Medical School, Jeonju, Korea
12Division of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
13Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea
14Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea
15Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea
16Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
17Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
18Astellas Pharma Singapore Pte. Ltd., Singapore
19Medical Affairs, Astellas Pharma Korea Inc., Seoul, Korea
*Some content from this manuscript was previously presented at the 2024 American Association for Cancer Research – Korean Cancer Association (AACR-KCA) Joint Conference on Precision Medicine in Cancer; November 21-22, 2024; Seoul, Korea
2Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea
3Department of Oncology/Hematology, Kyungpook National University Chilgok Hospital, Daegu, Korea
4Department of Medical Oncology, Gachon University Gil Medical Center, Incheon, Korea
5Division of Medical Oncology, Department of Internal Medicine, The Catholic University of Korea St. Vincent's Hospital, Suwon, Korea
6Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea
7Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
8Division of Medical Oncology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea
9Department of Medical Oncology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea
10Division of Hemato-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea
11Division of Oncology and Hematology, Department of Internal Medicine, Jeonbuk National University Hospital, Jeonbuk National University Medical School, Jeonju, Korea
12Division of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
13Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea
14Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea
15Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea
16Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
17Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
18Astellas Pharma Singapore Pte. Ltd., Singapore
19Medical Affairs, Astellas Pharma Korea Inc., Seoul, Korea
*Some content from this manuscript was previously presented at the 2024 American Association for Cancer Research – Korean Cancer Association (AACR-KCA) Joint Conference on Precision Medicine in Cancer; November 21-22, 2024; Seoul, Korea
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Corresponding author:
Min-Hee Ryu
Tel: 82-2-3010-5935
Email: miniryu@amc.seoul.kr
Received: 28 August 2025 • Accepted: 4 December 2025
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Abstract
Purpose
The phase 3 SPOTLIGHT and GLOW trials, in patients with claudin 18 isoform 2–positive, human epidermal growth factor receptor 2–negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) with first-line zolbetuximab plus chemotherapy versus placebo plus chemotherapy. This analysis evaluated efficacy and safety in the Korean subgroup from SPOTLIGHT and GLOW.
Materials and Methods
Patients were randomized 1:1 to receive zolbetuximab plus chemotherapy or placebo plus chemotherapy (mFOLFOX6 [modified folinic acid, 5-fluorouracil, and oxaliplatin] or CAPOX [capecitabine and oxaliplatin]). Primary endpoint was PFS, assessed per RECIST v1.1 by independent review committee. Other efficacy and safety parameters were assessed.
Results
The Korean subgroup consisted of 49 patients in the zolbetuximab group and 47 in the placebo group. Median PFS (95% confidence interval [CI]) was 12.3 months (7.3-15.3), and median OS was 30.5 months (16.1-45.5) with zolbetuximab versus 8.1 months (4.2-10.4) and 15.8 months (11.8-19.7) with placebo, respectively. Most common TEAEs in patients who received zolbetuximab versus placebo were nausea (79.6% vs. 53.2%), vomiting (55.1% vs. 21.3%), and decreased appetite (53.1% vs. 23.4%). Treatment-related TEAEs led to discontinuation of zolbetuximab and placebo in 4.1% and 2.1% of patients, respectively.
Conclusion
Zolbetuximab plus chemotherapy demonstrated favorable PFS and OS versus placebo plus chemotherapy in the Korean subgroup, with numerically greater efficacy compared with the overall pooled population. This may be potentially attributable to low rates of zolbetuximab discontinuation and toxicity management.
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