Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024;20(26):1861-1877.
doi: 10.1080/14796694.2024.2342107. Epub 2024 May 24.

Zolbetuximab plus chemotherapy for locally advanced unresectable or metastatic stomach or gastroesophageal junction cancers: a plain language summary

Kohei Shitara  1 , Manish A Shah  2 , Florian Lordick  3 , Yung-Jue Bang  4 , David Ilson  5 , Eric Van Cutsem  6 , Peter Enzinger  7 , Sunnie S Kim  8 , Samuel J Klempner  9 , Diarmuid Moran  10 , Jung Wook Park  10 , Pranob Bhattacharya  10 , Jaffer A Ajani  11 , Rui-Hua Xu  12
Affiliations

Zolbetuximab plus chemotherapy for locally advanced unresectable or metastatic stomach or gastroesophageal junction cancers: a plain language summary

Kohei Shitara et al. Future Oncol. 2024.

Abstract

What is this summary about?: This is a summary of two articles. The first article is about a clinical trial called SPOTLIGHT and it was published in the medical journal The Lancet in in April of 2023. The second article is about a clinical trial called GLOW and it was published in the medical journal Nature Medicine in July of 2023.

What are the key takeaways?: Until recently, chemotherapy was the first treatment given to people with stomach cancer or gastroesophageal junction (or GEJ) cancer that is locally advanced unresectable or metastatic. When cancer cells have high amounts of the protein CLDN18.2 but do not have high amounts of the protein HER2, the cancer is known as CLDN18.2-positive (or CLDN18.2+) and HER2-negative (or HER2-). New medicines to treat cancer are being developed. These medicines attach to proteins on cancer cells to help the body recognize and kill cancer cells.The clinical trials SPOTLIGHT and GLOW included participants with CLDN18.2+ and HER2- stomach or GEJ cancer that was locally advanced unresectable or metastatic. These trials looked at whether adding a medicine called zolbetuximab to chemotherapy as the first treatment for cancer helped people live longer before their tumors grew bigger or new tumors grew, after starting the trial. These studies also looked at whether adding zolbetuximab to chemotherapy helped people live longer after starting the trial.

What were the main conclusions reported by the researchers?: In SPOTLIGHT and GLOW, on average, participants assigned to zolbetuximab plus chemotherapy lived 1.4 to 1.9 months longer before their tumors grew bigger or new tumors grew, after starting the trial, than participants assigned to a placebo plus chemotherapy. On average, participants assigned to zolbetuximab plus chemotherapy also lived 2.2 to 2.7 months longer, after starting the trial, than participants assigned to a placebo plus chemotherapy. These results suggest that zolbetuximab plus chemotherapy could be a new first treatment for people with CLDN18.2+ and HER2- stomach or GEJ cancer that is locally advanced unresectable or metastatic.Clinical Trial Registration: NCT03504397 (SPOTLIGHT); NCT03653507 (GLOW).

Keywords: CLDN18.2+; HER2–; lay summary; locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer; plain language summary; zolbetuximab.

Plain language summary

The clinical trials SPOTLIGHT and GLOW showed that, on average, participants with stomach or GEJ cancer assigned to zolbetuximab plus chemotherapy lived 2.2 to 2.7 months longer than participants assigned to a placebo plus chemotherapy.

PubMed Disclaimer

Conflict of interest statement

KS reports receiving research funding from Astellas Pharma Inc., Ono Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical, Chugai Pharmaceutical Co., MSD, Amgen, Eisai, and Medi Science; receiving consulting fees from Eli Lilly and Company, Bristol Myers Squibb, Takeda Pharmaceutical Company, Pfizer, Ono Pharmaceutical, Novartis, AbbVie, Daiichi Sankyo, Taiho Pharmaceutical, GSK, Amgen, Boehringer Ingelheim, MSD, Astellas Pharma Inc., Guardant Health Japan, and Janssen Pharmaceuticals; and receiving payment or honoraria from Bristol Myers Squibb, Takeda Pharmaceutical Company, and Janssen Pharmaceuticals. MAS reports receiving research funding from Astellas Pharma Inc., Merck, Bristol Myers Squibb, and Oncolys BioPharma; and serving a leadership or judiciary role in board, society, committee, or advocacy groups for the ASCO Leadership Council. FL reports receiving research funding from Astellas Pharma Inc.; receiving consulting fees from Amgen, Astellas Pharma Inc., Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly and Company, MSD, Novartis, and Roche; receiving payment or honoraria from Amgen, Astellas Pharma Inc., AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly and Company, Elsevier, Falk Foundation, Incyte Corporation, Medscape, MedUpdate GmbH, Merck, MSD, Novartis, Roche, Servier Laboratories, Springer Nature, and Streamed Up; receiving support for travel and/or meeting attendance from Bristol Myers Squibb; and participating on data safety monitoring boards or advisory boards for BioNTech SE. Y-JB reports receiving research funding from Astellas Pharma Inc., Genentech, Roche, Merck Serono, Daiichi Sankyo, Merck Sharp & Dohme, Amgen and BeiGene and receiving consulting fees from Merck Sharp & Dohme, Daiichi Sankyo, ALX Oncology, Hanmi Pharmaceutical, Merck Serono, Astellas Pharma Inc., Samyang Biopharm Corporation and Daewoong Pharmaceutical. DI reports receiving research funding from Astellas Pharma Inc.; receiving consulting fees from Amgen, Bayer, Astellas Pharma Inc., Merck, Daiichi Sankyo, Taiho Pharmaceutical, Natera Inc, Bristol Myers Squibb, Eli Lilly and Company, Roche, and AstraZeneca; and participating on data safety monitoring boards or advisory boards for MacroGenics, and Merck. EVC reports receiving research funding from Astellas Pharma Inc., Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Ipsen, Eli Lilly and Company, MSD, Merck KGaA, Novartis, Roche, and Servier Laboratories; and receiving consulting fees from AbbVie, Array BioPharma, Astellas Pharma Inc., AstraZeneca, Bayer, BeiGene, Biocartis, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Halozyme, GSK, Helsinn Healthcare SA, Incyte Corporation, Ipsen, Janssen Pharmaceuticals, Eli Lilly and Company, MSD, Merck KGaA, Mirati Therapeutics Inc, Novartis, Laboratoires Pierre Fabre, Roche, Seagen, Servier Laboratories, Sirtex Medical, Terumo Corporation, Taiho Pharmaceutical, TRIGR, and Zymeworks. PE reports receiving research funding from Astellas Pharma Inc.; and receiving consulting fees from ALX Oncology, Arcus Biosciences, Astellas Pharma Inc., AstraZeneca, Blueprint Medicines, Bristol Myers Squibb, Chimeric Therapeutics, Celgene, Coherus BioSciences, Daiichi Sankyo, Five Prime Therapeutics, Inc., IDEAYA Biosciences, Istari Oncology, Legend Biotech, Eli Lilly and Company, Loxo Oncology, Merck, Novartis, Ono Pharmaceutical, Servier Laboratories, Taiho Pharmaceutical, Takeda Pharmaceutical Company, Turning Point Therapeutics, Inc., Xencor, and Zymeworks. SSK reports receiving research funding from Astellas Pharma Inc. and Merck and receiving consulting fees from Merck, Astellas Pharma Inc., and I-MAB. SJK reports receiving research funding from Astellas Pharma Inc.; reports holding stock/equity in Turning Point Therapeutics and Nuvalent; and has served a consultant/advisory role for Bristol Myers Squibb, Merck, Eli Lilly, Astellas, Daiichi-Sankyo, Pieris, Natera, Novartis, AstraZeneca, Mersana, Sanofi-Aventis, Servier, and Coherus. DM, JWP, and PB are a full-time employees of Astellas Pharma Inc. JAA reports receiving study funding from Astellas Pharma Inc., Turning Point Therapeutics, Inc., Bristol Myers Squibb, Merck, Taiho Pharmaceutical, Delta-Fly Pharma, Inc., Roche, ProLynx Inc, Zymeworks, Daiichi Sankyo, Leap Therapeutics, Inc., Gilead Sciences, Inc., and Lanova Pharma; receiving consulting fees from Bristol Myers Squibb, Merck, Astellas Pharma Inc., Amgen, Taiho Pharmaceutical, Zymeworks, BeiGene, AstraZeneca, Daiichi Sankyo, Bayer, GRAIL, Novartis, Geneos, Servier Laboratories, and Gilead Sciences, Inc.; receiving support for travel and/or meeting attendance from Daiichi Sankyo, Bristol Myers Squibb, and Merck; and participating on data safety monitoring board or advisory board for BeiGene. R-HX reports receiving research funding from Astellas Pharma Inc. These trials were sponsored by Astellas Pharma Inc. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Similar articles

See all similar articles

Publication types

MeSH terms

Associated data