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

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2024年9月4日

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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

摘要

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.