BJC Reports (Sep 2024)

Phase 1b/2 study of the liposomal formulation of eribulin (E7389-LF) in combination with nivolumab: Results from the phase 2 esophageal cancer cohort

  • Takashi Oshima,
  • Sachiko Yamamoto,
  • Hisato Kawakami,
  • Tomoki Makino,
  • Akihito Kawazoe,
  • Toshiki Masuishi,
  • Takahiro Tsushima,
  • Motohiro Hirao,
  • Masahiro Tsuda,
  • Kaori Hino,
  • Noboru Yamamoto,
  • Hiroki Hara,
  • Shota Kaname,
  • Daiko Matsuoka,
  • Yohei Otake,
  • Keisuke Yasuda,
  • Takao Takase,
  • Shuya Takashima,
  • Taro Semba,
  • Akira Ooki

DOI
https://doi.org/10.1038/s44276-024-00066-6
Journal volume & issue
Vol. 2, no. 1
pp. 1 – 7

Abstract

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Abstract Background Esophageal cancer is one of the most common types of cancer in Japan. Herein, we report the efficacy and safety of E7389-LF plus the immune checkpoint inhibitor, nivolumab, from the esophageal cancer cohort of the phase 2 part of Study 120. Methods Eligible patients received E7389-LF 2.1 mg/m2 plus nivolumab 360 mg intravenously Q3W. The primary objective was to evaluate the objective response rate (ORR); other objectives included safety, progression-free survival (PFS), and overall survival (OS). Results Of the 35 Japanese patients enrolled, 7 (20.0%) had a partial response as their best overall response, and 14 (40.0%) had stable disease. The ORR was 20.0% (95% CI 8.4–36.9). The duration of response was 5.6 months (95% CI 1.7–not estimable [NE]). The median PFS was 2.81 months (95% CI 1.31–4.17). The median OS was not reached (95% CI 6.54 months–NE). The most common treatment-emergent adverse events were neutropenia (65.7%), pyrexia (60.0%), and leukopenia (57.1%). Select plasma endothelial cell markers levels increased from day 1 of cycle 1 and changes were pronounced between days 8–15 of each cycle. Conclusions E7389-LF plus nivolumab showed antitumor activity in patients with unresectable and pretreated esophageal cancer and should be evaluated further in a broader population. Clinical Trial Registration NCT04078295.