Abstract 140P
Background
New therapies are needed for pts with LA unresectable or mG/GEJ adenocarcinoma. CLDN18.2 is a novel validated target expressed in healthy gastric mucosa, often retained in G/GEJ tumor cells. The phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies demonstrated clinically meaningful and statistically significant improvement in progression-free and overall survival with first-line (1L) zolbetuximab (anti-CLDN18.2) + chemotherapy (mFOLFOX6 or CAPOX, respectively) vs placebo + chemotherapy in pts with CLDN18.2+/HER2− disease. We report the biomarker analysis of pts in the Asia region (Japan, Malaysia, South Korea, Taiwan, Thailand).
Methods
Pts with LA unresectable or mG/GEJ adenocarcinoma were screened for CLDN18.2 status by immunohistochemistry (IHC) during screening. Tumors with ≥75% tumor cells with moderate-to-strong membranous CLDN18 staining per the investigational VENTANA CLDN18 (43-14A) RxDx Assay were defined as CLDN18.2+. HER2 status was screened per central/local assessment. Pts in mainland China were excluded.
Results
Across SPOTLIGHT and GLOW, 36.4% (465/1276) of pts in the Asia region with valid CLDN18 IHC results had CLDN18.2+ tumors. The prevalence of CLND18.2 positivity was 46.2% (73/158) in pts from Thailand, 40.2% (41/102) in pts from Malaysia, 39.0% (64/164) in pts from Taiwan, 35.3% (153/434) in pts from Japan, and 32.1% (134/418) in pts from South Korea. The prevalence of CLDN18.2 positivity was 41.0% (178/434) in women and 34.1% (287/842) in men; and 38.4% (296/771) in pts ≤65 years of age and 33.5% (169/505) in pts >65 years of age.
Conclusions
A high CLDN18.2 prevalence rate (36.4%) was observed in the Asia region which was similar to the global prevalence observed in both the SPOTLIGHT and GLOW phase 3 studies. These data support the relevance of CLDN18.2 as a biomarker in Asian pts with LA unresectable or mG/GEJ adenocarcinoma, for whom zolbetuximab + chemotherapy represents a potential 1L therapy.
Clinical trial identification
NCT03504397, NCT03653507.
Editorial acknowledgement
Medical writing support, conducted in accordance with Good Publication Practice (GPP 2022) and the International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Ann Ferguson, PhD, of Oxford PharmaGenesis Inc., and was funded by Astellas Pharma Inc.
Legal entity responsible for the study
Astellas Pharma Inc.
Funding
Astellas Pharma Inc.
Disclosure
Y. Bang: Financial Interests, Personal, Research Funding: Astellas Pharma Inc., Genentech, Roche, Merck Serono, Daiichi Sankyo, MSD, Amgen, and BeiGene; Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, Daiichi Sankyo, ALX Oncology, Hanmi Pharmaceutical, Merck Serono, Astellas Pharma Inc., Samyang Biopharm Corporation, and Daewoong Pharmaceutical. L. Shen: Financial Interests, Personal, Other, Consulting fees: Mingji biopharmaceutical, Haichuang pharmaceutical, Herbour biomed; Financial Interests, Personal, Advisory Board: MSD, Merck, BMS, BI, Sanofi, Roche, Servier, AZ; Financial Interests, Institutional, Funding: Beijing Xiantong Biomedical Technology, Qilu Pharmaceutical, ZaiLab Pharmaceutical (Shanghai), Alphamab Oncology, Yaojie Ankang (Nanjing) Technology Co., Ltd., BeiGene, Ltd., Qiyu Biotechnology (Shanghai) Co., Ltd., BriSTAR immunotech; Financial Interests, Institutional, Local PI: Merck Healthcare KGaA, Roche; Financial Interests, Institutional, Trial Chair: Rongchang Pharmaceutical, Innovent, BeiGene, Ltd., NovaRock Biotherapeutics Limited, Qilu Pharmaceutical. Y. Kang: Financial Interests, Personal, Advisory Board: ALX Oncology, Zymeworks, Amgen, Novartis, Macrogenics, Daehwa, Blueprint, Surface Oncology, BMS, Merck, Roche, Liscure. Y. Chao: Financial Interests, Personal, Research Grant: Astellas Pharma Global Development, Inc. H.H.F. Soo, P. Sunpaweravong: Financial Interests, Personal, Research Funding: Astellas Pharma Global Development, Inc. D. Moran, A. Guerrero, R. Li, J. Pavese, M. Matsangou, P. Bhattacharya: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma Global Development, Inc. K. Shitara: Financial Interests, Personal, Advisory Board: Lilly, Bristol Myers Squibb, Takeda, Pfizer, Ono, MSD, Taiho, Novartis, AbbVie, GSK, Daiichi Sankyo, Amgen, Boehringer Ingelheim, Guardant Health Japan Corp, Astellas Pharma Inc.; Financial Interests, Institutional, Research Grant: Astellas, Ono, Daiichi Sankyo, Taiho, Chugai, MSD, Eisai, Amgen; Financial Interests, Personal, Invited Speaker: Janssen Pharmaceutical K.K. R. Xu: Financial Interests, Personal, Invited Speaker: BMS, MSD; Financial Interests, Personal, Advisory Board: Henrui, BeiGene, Astellas, Merck, Junshi.
Resources from the same session
472P - Risk of recurrence and optimal adjuvant treatment in invasive lung adenocarcinomas manifesting as radiological part-solid nodules
Presenter: Yang Wo
Session: Poster Display
Resources:
Abstract
473P - Treatment (tx) patterns in resectable stage IA–IIIA non-small cell lung cancer (NSCLC) in China: Subgroup analysis of a global real-world (rw) study
Presenter: Chih-Chi Yang
Session: Poster Display
Resources:
Abstract
474P - The efficacy of image guided coil localisation for surgical resection of undiagnosed solitary lung nodule
Presenter: Jun Rey Leong
Session: Poster Display
Resources:
Abstract
475P - 5-year overall survival and disease free survival outcome between lobectomy and segmentectomy for early stage lung cancer in a mixed Asian population
Presenter: Jianye Chen
Session: Poster Display
Resources:
Abstract
478P - Peri-operative risks in curative lung resection of early stage primary lung cancer patients above 70 years old in a mixed Asian population
Presenter: Ian Goh
Session: Poster Display
Resources:
Abstract
480P - Aumolertinib as adjuvant therapy for resectable stage I-III EGFR-mutant NSCLC: Also effective in EGFR co-mutation
Presenter: Lin Wu
Session: Poster Display
Resources:
Abstract
481P - Comparative analysis of three NGS platforms assessing tumor mutational burden and mutational landscape in resectable non-small cell lung cancer
Presenter: Jii Bum Lee
Session: Poster Display
Resources:
Abstract
482P - Prevalence of EGFR mutations (EGFRm) and its subtypes in patients (pts) with resected stage I-III NSCLC: Results from EARLY-EGFR Singapore cohort
Presenter: Puey Ling Chia
Session: Poster Display
Resources:
Abstract
483P - Genetic profiles and evolutionary trajectory of early stage lung adenocarcinoma (AAH, AIS, MIA and IAC) revealed by multiplex sequecing
Presenter: lixuan lin
Session: Poster Display
Resources:
Abstract
484P - Treatment (tx) patterns and outcomes in resectable early-stage EGFR-mutated (EGFRm) NSCLC in South Korea: Subgroup analysis of a global real-world (rw) study
Presenter: Myung-Ju Ahn
Session: Poster Display
Resources:
Abstract