Supplementary Table 2 from Phase 1b/2 Study of a Liposomal Formulation of Eribulin (E7389-LF) Plus Nivolumab in Patients with Advanced Solid Tumors: Results from Phase 1b

Ida, Hanae; Shimizu, Toshio; Nishino, Makoto; Nakamura, Yoshiaki; Yazaki, Shu; Katsuya, Yuki; Sato, Jun; Koyama, Takafumi; Iwasa, Satoru; Sudo, Kazuki; Kondo, Shunsuke; Yonemori, Kan; Shitara, Kohei; Shiono, Satoshi; Matsuoka, Daiko; Yasuda, Keisuke; Otake, Yohei; Suzuki, Takuya; Takase, Takao; Takashima, Shuya; Yamaguchi, Kohei; Semba, Taro; Yamamoto, Noboru

doi:10.1158/2767-9764.23523731.v1

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Supplementary Table 2 from Phase 1b/2 Study of a Liposomal Formulation of Eribulin (E7389-LF) Plus Nivolumab in Patients with Advanced Solid Tumors: Results from Phase 1b

journal contribution

posted on 2023-06-15, 14:20 authored by Hanae Ida, Toshio Shimizu, Makoto Nishino, Yoshiaki Nakamura, Shu Yazaki, Yuki Katsuya, Jun Sato, Takafumi Koyama, Satoru Iwasa, Kazuki Sudo, Shunsuke Kondo, Kan Yonemori, Kohei Shitara, Satoshi Shiono, Daiko Matsuoka, Keisuke Yasuda, Yohei Otake, Takuya Suzuki, Takao Takase, Shuya Takashima, Kohei Yamaguchi, Taro Semba, Noboru Yamamoto

Supplementary Table 2. Representativeness of Study Patients

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ARTICLE ABSTRACT

Purpose: To determine a recommended dose of liposomal eribulin (E7389-LF) in combination with nivolumab in patients with advanced solid tumors, and to evaluate the safety, efficacy, pharmacokinetics, and biomarker impact of this regimen. Patients and Methods: Japanese patients with advanced, nonresectable, or recurrent solid tumors and no existing alternative standard/effective therapy (except nivolumab monotherapy) were assigned to either E7389-LF 1.7 mg/m2 plus nivolumab 360 mg every 3 weeks (Q3W), E7389-LF 2.1 mg/m2 plus nivolumab 360 mg Q3W, E7389-LF 1.1 mg/m2 plus nivolumab 240 mg every 2 weeks (Q2W), or E7389-LF 1.4 mg/m2 plus nivolumab 240 mg Q2W. Primary objectives were to evaluate the safety/tolerability of each dose cohort and to determine the recommended phase 2 dose (RP2D). Secondary/exploratory objectives, including safety (dose-limiting toxicities [DLTs] and adverse events [AEs]), pharmacokinetics, efficacy (including objective response rate [ORR]), and biomarker results were used in determining the RP2D. Results:Twenty-five patients were enrolled to treatment (E7389-LF 1.7 mg/mg2 Q3W [n=6], E7389-LF 2.1 mg/m2 Q3W [n=6], E7389-LF 1.1 mg/m2 Q2W [n=7], E7389-LF 1.4 mg/m2 Q2W [n=6]). Twenty-four patients were evaluated for DLTs, of whom 3 had DLTs (1 at E7389-LF 1.7 mg/m2 Q3W, 1 at 1.1 mg/m2 Q2W, and 1 at 1.4 mg/m2 Q2W). All patients had ≥1 treatment related treatment-emergent AE (TEAE); 68.0% had ≥1 grade 3-4 treatment-related TEAE. Changes in vasculature and interferon-related biomarkers were seen in each cohort. The overall ORR was 16%. Conclusions: E7389-LF plus nivolumab was tolerable overall; the recommended dose for future studies was 2.1 mg/m2 plus nivolumab 360 mg Q3W.