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Ann Oncol. 2018 Oct 1;29(10):2052-2060. doi: 10.1093/annonc/mdy264.

Phase III, randomised trial of avelumab versus physician's choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300.

Author information

1
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
2
Universidad de la Frontera, Temuco, Chile.
3
Department of Digestive Oncology, University Hospitals Gasthuisberg/Leuven, KU Leuven, Leuven, Belgium.
4
Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
5
Department of Gastrointestinal Cancer, M. Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland.
6
Centrul de Oncologie Sf. Nectarie, Craiova, Romania.
7
Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.
8
Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
9
Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea.
10
Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
11
Department of Clinical Oncology and Hematology, Krankenhaus Nordwest, Frankfurt, Germany.
12
Department of Medicine, Samsung Medical Center, Seoul, South Korea.
13
Department of Chemotherapy and Combined Therapy, N. N. Blokhin Russian Oncological Scientific Center, Russian Academy of Medical Sciences, Moscow, Russian Federation.
14
Department of Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
15
Department of Internal Medicine, Johannes Gutenberg University Mainz, Mainz, Germany.
16
Global Clinical Development Immuno-Oncology, EMD Serono, Billerica, USA.
17
Global Research & Development, Merck KGaA, Darmstadt, Germany.
18
Department of Gastroenterology and Digestive Oncology, Université Sorbonne Paris Cité, Paris Descartes University, Georges Pompidou European Hospital, Paris, France.

Abstract

Background:

There currently are no internationally recognised treatment guidelines for patients with advanced gastric cancer/gastro-oesophageal junction cancer (GC/GEJC) in whom two prior lines of therapy have failed. The randomised, phase III JAVELIN Gastric 300 trial compared avelumab versus physician's choice of chemotherapy as third-line therapy in patients with advanced GC/GEJC.

Patients and methods:

Patients with unresectable, recurrent, locally advanced, or metastatic GC/GEJC were recruited at 147 sites globally. All patients were randomised to receive either avelumab 10 mg/kg by intravenous infusion every 2 weeks or physician's choice of chemotherapy (paclitaxel 80 mg/m2 on days 1, 8, and 15 or irinotecan 150 mg/m2 on days 1 and 15, each of a 4-week treatment cycle); patients ineligible for chemotherapy received best supportive care. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.

Results:

A total of 371 patients were randomised. The trial did not meet its primary end point of improving OS {median, 4.6 versus 5.0 months; hazard ratio (HR)=1.1 [95% confidence interval (CI) 0.9-1.4]; P = 0.81} or the secondary end points of PFS [median, 1.4 versus 2.7 months; HR=1.73 (95% CI 1.4-2.2); P > 0.99] or ORR (2.2% versus 4.3%) in the avelumab versus chemotherapy arms, respectively. Treatment-related adverse events (TRAEs) of any grade occurred in 90 patients (48.9%) and 131 patients (74.0%) in the avelumab and chemotherapy arms, respectively. Grade ≥3 TRAEs occurred in 17 patients (9.2%) in the avelumab arm and in 56 patients (31.6%) in the chemotherapy arm.

Conclusions:

Treatment of patients with GC/GEJC with single-agent avelumab in the third-line setting did not result in an improvement in OS or PFS compared with chemotherapy. Avelumab showed a more manageable safety profile than chemotherapy.

Trial registration:

ClinicalTrials.gov: NCT02625623.

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