Meeting
2024 ASCO Gastrointestinal Cancers Symposium
HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.
Authors
Jin Li
Department of Medical Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China
Jin Li , Yong Gao , Ning Li , Meng Qiu , Yan-Qiao Zhang , Mudan Yang , Linzhi Lu , Wei Li , Yuntao Ma , Xiaoming Hou , Guoping Sun , Mingquan Cai , Jingran Wang , Jianwei Lu , Diansheng Zhong , Futang Yang , Jing Li , Qingyu Wang , Jun Zhu
Organizations
Department of Medical Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China, Department of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China, Department of Abdominal Oncology, West China School of Medicine and West China Hospital, Sichuan University, Chengdu, China, Department of Gastrointestinal Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China, Department of Gastroenterology, Shanxi Cancer Hospital, Taiyuan, China, Department of Gastroenterology, Gansu Wuwei Tumour Hospital, Wuwei, China, Cancer Center, The First Hospital of Jilin University, Changchun, China, Department of General Surgery, Gansu Provincial Hospital, Lanzhou, China, Department of Medical Oncology, The First Hospital of Lanzhou University, Lanzhou, China, Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China, Department of Medical Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, China, Department of Oncology, Shijiazhuang People’s Hospital, Shijiazhuang, China, Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China, Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin, China, Shanghai Henlius Biotech, Inc., Shanghai, China
Research Funding
Shanghai Henlius Biotech, Inc.
Background: Gastric/gastroesophageal junction (G/GEJ) cancer represents a global healthcare challenge. With more than 1 million new cases estimated in 2020, it ranked fifth among all cancers. HER2 amplification or overexpression were reported in around 20% of advanced G/GEJ cancer cases. Despite the improved overall survival with trastuzumab plus chemotherapy, the prognosis remains unsatisfactory, and thus more effective treatments are needed. This study aimed to evaluate the combination of HLX22 (a novel anti-HER2 monoclonal antibody), HLX02 (a trastuzumab biosimilar), and chemotherapy for patients with G/GEJ cancer in the first-line setting. Methods: The study was unblinded 3 months after the last patient was enrolled. Patients with locally advanced or metastatic HER2-positive G/GEJ cancer and had not received prior systemic antitumor therapy were enrolled. The study consisted of 2 parts; current report will focus on part 1. In part 1, patients were randomized 1:1:1 to receive HLX22 25 mg/kg + HLX02 + XELOX (group A), HLX22 15 mg/kg + HLX02 + XELOX (group B), or placebo + HLX02 + XELOX (group C) in 3-week cycles. Primary endpoints were PFS and ORR assessed by IRRC per RECIST v1.1. Secondary endpoints included other efficacy measures and safety. Results: As of July 30, 2023 (data cutoff), 53 patients were randomized to group A (n=18), B (n=17), and C (n=18), and were followed up for a median of 14.3 months. 44 (83.0%) patients were male. Main efficacy results are presented in Table. Tumor assessments reported in Table were performed by IRRC. Treatment-related adverse events (TRAEs) occurred in 18 (100.0%), 16 (94.1%), and 17 (94.4%) patients in the respective groups. Serious TRAEs were observed in 5 (27.8%) patients in group A, 1 (5.9%) in group B, and 1 (5.6%) in group C. Only 1 (5.6%) patient in group C had a grade 5 TRAE. Conclusions: Adding HLX22 to HLX02 + XELOX improved survival and antitumor response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile. Clinical trial information: NCT04908813.
| Group A (n=18) | Group B (n=17) | Group C (n=18) | |
|---|---|---|---|
| Median PFS, months (95% CI) | 15.1 (6.8, NE) | NR (9.9, NE) | 8.2 (5.7, 12.7) |
| HR* (95% CI) | 0.5 (0.2, 1.3) | 0.1 (0.0, 0.5) | - |
| Confirmed ORR, % (95% CI) | 77.8 (52.4, 93.6) | 82.4 (56.6, 96.2) | 88.9 (65.3, 98.6) |
| ORR at week 36, % (95% CI) | 44.4 (21.5, 69.2) | 64.7 (38.3, 85.8) | 27.8 (9.7, 53.5) |
| ORR at week 48, % (95% CI) | 38.9 (17.3, 64.3) | 58.8 (32.9, 81.6) | 16.7 (3.6, 41.4) |
| Median OS, months (95% CI) | NR (12.4, NE) | NR (NE, NE) | NR (6.4, NE) |
| HR* (95% CI) | 0.4 (0.1, 1.5) | 0.3 (0.1, 1.3) | - |
| Median DOR, months (95% CI) | 12.4 (5.5, NE) | NR (8.6, NE) | 6.8 (4.4, NE) |
| HR* (95% CI) | 0.6 (0.2, 1.6) | 0.1 (0.0, 0.5) | - |
*Hazard ratio (HR) was estimated between group A and C, as well as between group B and C. NE, not evaluable; NR, not reached.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Track
Esophageal and Gastric Cancer,Other GI Cancer
Sub Track
Therapeutics
Clinical Trial Registration Number
NCT04908813
Citation
J Clin Oncol 42, 2024 (suppl 3; abstr 354)
DOI
10.1200/JCO.2024.42.3_suppl.354
Abstract #
354
Poster Bd #
G15
Abstract Disclosures
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