Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4456 - Avelumab (anti–PD-L1) in Japanese patients with advanced gastric or gastroesophageal junction cancer (GC/GEJC): updated results from the phase 1b JAVELIN Solid Tumor JPN trial


21 Oct 2018


Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology


Clinical Research

Tumour Site

Gastric Cancer


Toshihiko Doi


Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282


T. Doi1, S. Iwasa2, K. Muro3, T. Satoh4, S. Hironaka5, T. Esaki6, T. Nishina7, H. Hara8, N. Machida9, Y. Komatsu10, Y. Shimada11, S. Otsu12, S. Shimizu13, V. Chand14, M. Watanabe15

Author affiliations

  • 1 Department Of Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2 Department Of Experimental Therapeutics, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 3 Department Of Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 4 Department Of Frontier Science For Cancer And Chemotherapy, Osaka University Hospital, Osaka/JP
  • 5 Clinical Trial Promotion Department, Chiba Cancer Center, Chiba/JP
  • 6 Department Of Gastrointestinal And Medical Oncology, National Kyushu Cancer Center, Fukuoka/JP
  • 7 Department Of Gastrointestinal Medical Oncology, Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 8 Department Of Gastroenterology, Saitama Cancer Center, Saitama/JP
  • 9 Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 4118777 - Shizuoka/JP
  • 10 Cancer Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 11 Clinical Oncology, Kochi Health Sciences Center, Kochi/JP
  • 12 Department Of Medical Oncology And Hematology, Oita University Hospital, Oita/JP
  • 13 Biostatistics, Merck Serono Co., Ltd, Tokyo/JP
  • 14 Clinical Development, EMD Serono, Inc, Billerica/US
  • 15 Clinical Development, Merck Serono Co., Ltd, Tokyo/JP


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 4456


Avelumab, a human anti–PD-L1 IgG1 monoclonal antibody that can induce innate effector function against tumor cells in preclinical models, is an approved treatment for metastatic Merkel cell carcinoma in various countries and platinum-treated advanced urothelial carcinoma in the US and Canada. We report updated results from the dose-expansion part of a phase 1b trial of avelumab in Japanese patients (pts) with advanced GC/GEJC (NCT01943461).


Pts had stage IV GC/GEJC adenocarcinoma and progression after 1 or 2 prior lines of chemotherapy including a platinum and fluoropyrimidine agent (initially enrolled pts) or progression after platinum/fluoropyrimidine followed by a taxane or irinotecan (later pts). Pts received avelumab 10 mg/kg Q2W by IV infusion until confirmed progression, unacceptable toxicity or withdrawal. PD-L1 expression was assessed using the Dako PD-L1 IHC 73-10 assay (≥1% tumor cell cutoff).


At data cutoff on Aug 10, 2016, 40 pts had received avelumab (median treatment duration 2.7 mo; range 0.5–21.4). 21 pts (52.5%) had received ≥3 prior lines of therapy for advanced disease. The objective response rate (ORR) was 10.0% (95% CI 2.8–23.7), including complete response in 1 pt and partial response in 3 pts. 17 pts had stable disease as best response and the disease control rate was 52.5%. Median progression-free survival was 2.5 mo (95% CI 1.4–2.8). Median overall survival (OS) was 9.1 mo (95% CI 7.2–11.2) and the 12-mo OS rate was 31.0% (95% CI 15.6–47.8). In evaluable pts with PD-L1 + (n = 11) or PD-L1 − (n = 27) tumors, ORR was 27.3% and 3.7%, respectively. Treatment-related adverse events (TRAEs) of any grade occurred in 32 pts (80.0%), including infusion-related reaction (27.5%; all grade 1/2), pruritus (15.0%), pyrexia (12.5%) and rash (10.0%) in ≥ 10% of pts. Grade 3 TRAEs occurred in 3 pts (7.5%; ALT increase, anemia and hyponatremia); no pt had a grade ≥4 TRAE. 5 pts had an immune-related AE (all grade 1/2); the most common were pruritus (n = 3) and maculopapular rash (n = 2).


Avelumab showed acceptable safety and clinical activity in Japanese pts with advanced GC/GEJC progressed after chemotherapy.

Clinical trial identification

EMR 100070-002 (NCT01943461).

Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany.


Merck KGaA, Darmstadt, Germany and Pfizer.

Editorial Acknowledgement

Medical writing support was provided by Clinical Thinking Inc, Hamilton, NJ, USA.


T. Doi: Consultancy (Includes expert testimony): Lilly, Japan Chugai Pharma, Kyowa, Hakko, Kirin, MSD, Daiichi Sankyo, Amgen, Sumitomo, Dainippon, Taiho Pharmaceutical; Research funding: Taiho Pharmaceutical, Novartis, Merck Serono, Astellas Pharma, MSD, Janssen, Boehringer Ingelheim, Takeda, Pfizer, Lilly, Japan Sumitomo Group, Chugai Pharma, Kyowa, Hakko, Kirin, Daiichi Sankyo, Celgene, Bristol-Myers Squibb, Abbvie, Quintiles. S. Iwasa: Honoraria: Chugai, Takeda; Research funding for institution: Otsuka, Taiho, Chugai, AstraZeneca, Novartis, Sanofi, Ono, Eli Lilly, Merck Serono, Daiichi-Sankyo, Nano Carrier, Teijin Pharma, Dainippon-Sumitomo, Astellas, Bayer, Abbvie, Eisai. K. Muro: Honoraria: Chugai, Taiho, Merck Serono, Yakult, Takeda. T. Satoh: Honoraria: Merck-Serono, Bristol-Myers Squibb, Chugai Pharmaceutical; Consulting or advisory role: Chugai Pharmaceutical, Eli Lilly, Merck Serono, Bristol-Myers Squibb; Research funding: Chugai Pharmaceutical, Yakult Honsha. S. Hironaka: Honoraria: Taiho, Yakult Honsha, Takeda, Novartis; Consulting or advisory role: Eli Lilly, Yakult Honsha. T. Esaki: Research funding: Merck Serono. T. Nishina: Honoraria: Merck Serono. H. Hara: Honoraria: Chugai Pharma; Taiho Pharmaceutical, Merck Serono, Yakult Honsha, Lilly, Ono Pharmaceutical, Takeda; Consulting or Advisory role: Ono Pharmaceutical, Chugai Pharma, Merck Serono, MSD; Research Funding for institution: AstraZeneca, Chugai Pharma, Merck Serono, MSD, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, Boehringer Ingelheim, Dainippon Sumitomo Pharma, Daiichi Sankyo, Lilly, Pfizer, LSK Biopharma, Eisai, Incyte. Y. Komatsu: Honoraria: Novartis, Pfizer, Bayer; Speakers\' bureau: Taiho, Lilly, Chugai, Merck, Novartis, Pfizer, Bayer; Research funding: Taiho, Lilly, MSD, Ono, Novartis, Bayer, Chugai, Yakult. S. Shimizu: Employee: Merck Serono Co, Ltd. V. Chand: Employee: EMD Serono Research & Development Institute, Inc; Stock Shareholder: Bristol-Meyers Squibb M. Watanabe: Employee: Merck Serono Co., Ltd. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.