Phase 1 study of the liposomal formulation of eribulin (E7389-LF): Results from the breast cancer expansion cohort

• DOI: 10.1016/j.ejca.2022.03.004
• Publication Date: 2022-04-29T22:04:22Z
• Authors: Norikazu Masuda; Makiko Ono; Toru Mukohara; Hiroyuki Yasojima; Tatsunori Shimoi; Kokoro Kobayashi; Kenichi Harano; Makiko Mizutani; Maki Tanioka; Shunji Takahashi; Takahiro Kogawa; Takuya Suzuki; Shiori Okumura; Takao Takase; Reiko Nagai; Taro Semba; Zi-Ming Zhao; Min Ren; Kan Yonemori
• Keywords: Pegfilgrastim; Eribulin; Leukopenia; Clinical endpoint

BackgroundA liposomal formulation of eribulin, E7389-LF, may provide improved pharmacokinetics and allow increased access to tumour tissues. This expansion a phase 1 study assessed the safety efficacy E7389-LF in patients with human epidermal growth factor receptor type 2-negative metastatic breast cancer.MethodsPatients received 2.0 mg/m2 every three weeks. Tumour assessments were conducted six weeks by investigator Response Evaluation Criteria Solid Tumours v1.1. All adverse events monitored recorded. Serum biomarker conducted.ResultsOf 28 included, 75.0% had hormone receptor-positive cancer (HR+ BC) 25.0% triple-negative (TNBC). The most common grade ≥3 treatment-related treatment-emergent included neutropenia (67.9%), leukopenia (42.9%), thrombocytopenia (32.1%), febrile (25.0%). Rates lower among who prophylactic pegfilgrastim. Objective response rate was 35.7% (95% confidence interval [CI]: 18.6–55.9) for all 42.9% CI: 21.8–66.0) HR+ BC. Median progression-free survival 5.7 months 3.9–8.3). median overall 18.3 13.2–not estimable). Among 54 biomarkers assessed, 27, including 5 7 vascular markers, significantly altered treatment from baseline any time point.ConclusionE7389-LF tolerable favourable antitumour activity observed, particularly Prophylactic pegfilgrastim can be considered at high risk neutropenia.Clinicaltrials.gov numberNCT03207672.