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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

3721 - Phase 1 study results from an esophageal squamous cell carcinoma (ESCC) cohort treated with M7824 (MSB0011359C), a bifunctional fusion protein targeting transforming growth factor _ (TGF-_) and PD-L1


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

Oesophageal Cancer


Chia-Chi Lin


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


C. Lin1, T. Doi2, K. Muro3, M. Hou4, T. Esaki5, H. Hara6, H. Chung7, M. Osada8, C. Helwig9, S. Kondo10

Author affiliations

  • 1 Department Of Oncology, National Taiwan University Hospital, 100 - Taipei city/TW
  • 2 Division Of Endoscopy And Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 3 Department Of Endoscopy, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 4 Division Of Hematology-oncology, Chang Gung Memorial Hospital-Linkou, 333 - Taoyuan/TW
  • 5 Department Of Gastrointestinal And Medical Oncology, National Kyushu Cancer Center, Fukuoka/JP
  • 6 Department Of Gastroenterology, Saitama Cancer Center, Saitama/JP
  • 7 Medical Oncology, Severance Hospital, Seoul/KR
  • 8 Medical Oncology, Merck Serono, Tokyo/JP
  • 9 Medical Oncology, Merck KGaA, Darmstadt/DE
  • 10 Department Of Hepatobiliary And Pancreatic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP


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Abstract 3721


Inhibition of the TGF-β pathway, which promotes tumor immunosuppression, may enhance the clinical response to PD-(L)1 monoclonal antibodies (mAbs). M7824 is an innovative first-in-class bifunctional fusion protein composed of a human anti–PD-L1 IgG1 mAb fused with 2 extracellular domains of the TGFβ receptor II to function as a TGF-β “trap”. We report on the safety and efficacy of M7824 in a cohort of Asian patients (pts) with ESCC. Esophageal cancer is the sixth most common type of cancer in Eastern Asia, with ESCC accounting for ≈90% of cases. ESCC represents an area of high unmet need. Additionally, no immunotherapies have been yet approved for this patient population, and monochemotherapy with a taxane or irinotecan remains the 2L standard of care (ORRs, ≤16%).


In this expansion cohort of the ongoing, phase 1 trial NCT02699515, Asian pts with ESCC unselected for PD-L1 expression, for which no standard therapy exists or has failed, received M7824 1,200 mg q2w until disease progression, unacceptable toxicity, or trial withdrawal. The primary objective is safety and tolerability; secondary objectives include best overall response per RECIST v1.1.


As of January 4, 2018, 30 pts received M7824 for a median of 6.1 (range, 2.0–44.1) weeks; 4 pts remained on treatment. 76.7% of patients had received ≥2 prior lines of treatment. The most common TRAEs were hypothyroidism, maculopapular rash (both 16.7%), rash (13.3%), and interstitial lung disease (ILD; 10.0%). Grade 3 TRAEs occurred in 4 pts (13.3%; eczema, increased amylase, lip SCC, maculopapular rash, rash); 2 grade 4 TRAEs were observed (6.7%; ILD, increased blood creatine phosphokinase). 3 treatment discontinuations, but no deaths, due to TRAEs occurred. 6 pts (confirmed ORR, 20.0%; unconfirmed ORR, 26.7%) had a partial response (duration of response, 1.4+, 2.8+, 4.2+, 4.2+, 5.8, and 7.0 months); 5 pts had stable disease (disease control rate, 36.7%) by investigator read.


M7824 had a manageable safety profile and promising preliminary efficacy in heavily pretreated Asian pts with ESCC and no/limited treatment options.

Clinical trial identification


Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany.


Merck KGaA.

Editorial Acknowledgement

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


T. Doi: Consultancy: Lilly Japan, Chugai Pharma, Kyowa Hakko Kirin, Merck Sharp and Dohme Corp, Daiichi Sankyo, Amgen, Sumitomo Dainippon, Taiho Pharmaceutical; Research funding: Taiho Pharmaceutical, Novartis, Merck Serono, Astellas Pharma, Merck Sharp and Dohme Corp, Janssen, Boehringer Ingelheim, Takeda, Pfizer, Lilly Japan, Sumitomo Group, Chugai Pharma, Kyowa Hakko Kirin, Daiichi Sankyo, Celgene, Bristol-Myers Squibb, Abbvie Quintiles. M-M. Hou: Employee: Chang Gung Memorial Hospital. 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, Merck Sharp & Dohme Corp; Research funding: AstraZeneca, Chugai Pharma, Merck Serono, Merck Sharp & Dohme Corp, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, Boehringer Ingelheim, Dainippon Sumitomo Pharma, Daiichi Sankyo, Lilly, Pfizer, LSK BioPharma, Eisai, Incyte. H-C. Chung: Employee: Yonsei University College of Medicine; Consultancy: Taiho, Celltrion, Merck Sharp and Dohme Corp, Lilly, Quintiles, Bristol-Myers Squibb, Merck-Serono; Research funding: Lilly, GlaxoSmithKline, Merck Sharp and Dohme Corp, Merck-Serono, Bristol-Myers Squibb/Ono, Taiho; Speakers bureau: Merck-Serono, Lilly, Foundation Medicine. M. Osada: Employee: Merck Serono. C. Helwig: Employee: Merck KGaA. All other authors have declared no conflicts of interest.

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