Gastric cancer (GC) cohort of a phase 2 trial of E7389-LF (liposomal formulation of eribulin) in combination with nivolumab.

• DOI: 10.1200/jco.2023.41.4_suppl.339
• Publication Date: 2023-01-24T21:05:07Z
• Authors: Kei Muro; Satoru Iwasa; Naotoshi Sugimoto; Hisato Kawakami; Takashi Oshima; Kensei Yamaguchi; Kaori Hino; Motohiro Hirao; Yukinori Kurokawa; Takeshi Kawakami; Naoki Takegawa; Hiroki Hara; Naoki Sumiyoshi; Daiko Matsuoka; Yohei Otake; Keisuke Yasuda; Takao Takase; Shuya Takashima; Taro Semba; Akihito Kawazoe
• Keywords: Eribulin; Taxane; Regimen; Combination therapy; Progression-free survival

339 Background: Due to a lack of efficacy and long-term survival seen in previously-studied therapies, new therapies for pretreated advanced GC are warranted. E7389-LF is formulation that uses liposomes encapsulate eribulin; this anticipated improve eribulin concentration tumor tissues. nivolumab have both shown as monotherapy GC. may also synergize well with PD-1 inhibitors by acting cytotoxic therapy modulating the microenvironment. Methods: Patients (pts) unresectable measurable GC, esophageal cancer, or small cell lung cancer who were previously treated 1 (2 GC) chemotherapy regimens enrolled phase 2 part Study 120 2.1 mg/m plus 360 mg every 3 weeks (Q3W). In cohort, pts had show disease progression from combination including platinum drug + fluoropyrimidine (1 st -line therapy) taxane-containing regimen nd therapy). The primary objective was evaluate response rate (ORR); secondary objectives included safety, progression-free (PFS), pharmacokinetics. Other (including overall [OS]) biomarker exploratory. Tumor responses assessed investigators per RECIST v1.1. Results: 31 included; median age 63 years; 18 male, 13 female. By data cutoff date (May 31, 2022), 29 discontinued (26 due progression, adverse events). 8 Pts partial (PR); ORR 25.8% (95% CI 11.9–44.6). PFS 2.69 months 1.91–2.99). OS 7.85 4.47–not estimable). 6-month 61.3%; 9-month 44.7%. 30 ≥1 treatment-related TEAE, most commonly neutropenia (n = 24); 25 at least grade ≥3 22). 16 TEAE resulting dose reduction E7389-LF. 4 withdrawal nivolumab, asthma, cerebral hemorrhage, decreased appetite, pulmonary edema, upper gastrointestinal hemorrhage (each n 1). an evaluable PD-L1 combined positive score (CPS); 5 20 (25.0%) CPS < 9 (22.2%) ≥5 PR. Increases pharmacodynamic markers vasculature-related observed; antitumor immunity observed changes interferon gamma (IFNγ) IFNγ-related markers. Conclusions: Q3W promising evidenced notable OS. No safety signals identified combination. Biomarker suggested vascular remodeling activity enhancement via IFNγ signaling. Clinical trial information: NCT04078295 .