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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

4543 - Updated results from a phase 1 trial of M7824 (MSB0011359C), a bifunctional fusion protein targeting PD-L1 and TGF-_, in patients with pretreated recurrent or refractory gastric cancer


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


Yung-Jue Bang


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


Y. Bang1, T. Doi2, S. Kondo3, H.C. Chung4, K. Muro5, I. Dussault6, C. Helwig7, M. Osada8, Y. Kang9

Author affiliations

  • 1 Internal Medicine (medical Oncology), Seoul National University Hospital, 110-744 - Seoul/KR
  • 2 Medical Oncology, National Cancer Center Hospital East, 277-8577 - Chiba/JP
  • 3 Hepatobiliary And Pancreatic Oncology Division, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 4 Oncology, Yonsei University College of Medicine, Seoul/KR
  • 5 Department Of Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 6 Clinical Biomarkers, Immuno-oncology, EMD Serono, Billerica/US
  • 7 Biostatistics, Merck KGaA, Darmstadt/DE
  • 8 Medical Oncology, Merck Serono, Tokyo/JP
  • 9 Medical Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR


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Abstract 4543


Objective response rates (ORRs) in patients (pts) with gastric cancer (GC) treated with anti–PD-(L)1 antibodies range from 11.2% (PD-L1 unselected) to 15.5% (PD-L1+) for second line therapy. Inhibiting the transforming growth factor β (TGF-β) pathway, which plays a key role in tumor immunosuppression, may enhance the response to anti–PD-L1 treatment. We report results for M7824, an innovative first-in-class bifunctional fusion protein composed of a monoclonal antibody against PD-L1 fused with the extracellular domain of TGF-β receptor II (a TGF-β “trap”) in pts with GC.


Pts in Asia with recurrent GC or gastroesophageal junction adenocarcinoma for whom standard therapy does not exist or has failed were enrolled in this expansion cohort of the ongoing, phase 1, open-label trial NCT02699515 and received M7824 1200 mg q2w until disease progression, unacceptable toxicity, or trial withdrawal. The primary objective is to assess safety/tolerability; secondary objectives include assessment of best overall response (BOR) per RECIST v1.1.


As of February 15, 2018, 31 heavily pretreated pts with advanced GC (74.2% received ≥3 prior therapies) received M7824 for a median duration of 10.1 (range, 2-52) wks; 4 pts remained on treatment. 6 pts (19.4%) had grade 3 treatment-related adverse events (TRAEs): anemia (2), diarrhea (1), abnormal hepatic function (1) and rash (2). No grade 4 TRAEs occurred. 1 Grade 5 AE of death occurred after 5 doses with suspected rupture of pre-existing thoracic aortic aneurysm as per investigator’s assessment. 7 pts had a confirmed objective response based on investigator-assessed BOR (ORR, 22.6%; DCR, 38.7%). There were 5 partial responses (2.4, 3.6+, 4.1+, 8.3+, and 9.7+ mo) and 2 complete responses (0.3+ and 9.0 mo). The initial assessment of PD-L1 tumor expression (22C3 assay) does not hint towards predictivity for ORR.


M7824 monotherapy had a manageable safety profile in heavily pretreated Asian pts (74% ≥3 prior therapies) with GC. Early signs of clinical efficacy, with an ORR of 22.6% and long lasting responses, are encouraging. Updated data will be presented.

Clinical trial identification


Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany.


Merck KGaA, Darmstadt, Germany.

Editorial Acknowledgement

Medical writing support was provided by ClinicalThinking, and was funded by Merck KGaA, Darmstadt, Germany.


Y-J. Bang: Consultancy (Includes expert testimony): AstraZeneca, Novartis, Genentech/Roche, MSD, Pfizer, Bayer, BMS, Eli Lilly, Merck Serano, FivePrime, Taiho, Ono, ADC Therapeutics, GreenCross, Samyang Biopharm; Research funding (institution): AstraZeneca, Novartis, Genentech/Roche, MSD, Merck Serono, Bayer, GSK, BMS, Pfizer, Eli Lilly, Boeringer-Ingelheim, MacroGenics, Boston Biomedical, FivePrime, CKD Pharma, Ono, Otsuka, Taiho, Takeda, BeiGene, Hanmi, Green Cross, Curis, Daiichi Sankyo, Astellas. 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. Kondo: Research funding: MSD, Bayer, ASLAN, Pfizer, AZ, Lilly. H.C. Chung: Consultancy (Includes expert testimony): Taiho, Celltrion, MSD, Lilly, Quintiles, BMS, MerckSerono; Research funding: Lilly, GSK, MSD, MerckSerono, BMS/Ono, Taiho; Speakers bureau MerckSerono, Lilly, Foundation Medicine. I. Dussault: Employee: EMD Serono C. Helwig: Employee, Equity ownership: Merck KGaA, Germany. M. Osada: Employee: Merck Serono, Japan. All other authors have declared no conflicts of interest.

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