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

Y. J. Bang, E. Yañez Ruiz, E. Van Cutsem, K. W. Lee, L. Wyrwicz, M. Schenker, M. Alsina, M. H. Ryu, H. C. Chung, L. Evesque, S. E. Al-Batran, S. H. Park, M. Lichinitser, N. Boku, M. H. Moehler, J. Hong, H. Xiong, R. Hallwachs, I. Conti, J. Taieb

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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/m 2 on days 1, 8, and 15 or irinotecan 150 mg/m 2 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)¼1.1 [95% confidence interval (CI) 0.9-1.4]; P ¼ 0.81} or the secondary end points of PFS [median, 1.4 versus 2.7 months; HR¼1.73 (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.

Original languageEnglish
Pages (from-to)2052-2060
Number of pages9
JournalAnnals of Oncology
Volume29
Issue number10
DOIs
Publication statusPublished - 2018

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

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    Bang, Y. J., Yañez Ruiz, E., Van Cutsem, E., Lee, K. W., Wyrwicz, L., Schenker, M., Alsina, M., Ryu, M. H., Chung, H. C., Evesque, L., Al-Batran, S. E., Park, S. H., Lichinitser, M., Boku, N., Moehler, M. H., Hong, J., Xiong, H., Hallwachs, R., Conti, I., & Taieb, J. (2018). 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. Annals of Oncology, 29(10), 2052-2060. https://doi.org/10.1093/annonc/mdy264