Eribulin plus pembrolizumab in patients with metastatic triple-negative breast cancer (ENHANCE 1): A phase Ib/II study

Sara M. Tolaney, Kevin Kalinsky, Virginia G. Kaklamani, David R. D'Adamo, Gursel Aktan, Michaela L. Tsai, Ruth M. O'Regan, Peter A. Kaufman, Sharon T. Wilks, Eleni Andreopoulou, Debra A. Patt, Yuan Yuan, Grace Wang, Claudio Savulsky, Dongyuan Xing, Ella Kleynerman, Vassiliki Karantza, Sami Diab

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: As monotherapies, eribulin (chemotherapy) and pembrolizumab (immunotherapy) have shown promise for patients with metastatic triple-negative breast cancer (mTNBC). This phase Ib/II study examined eribulin plus pembrolizumab as a potential mTNBC treatment in first-line and later-line settings. Patients and Methods: In this open-label, single-arm, phase Ib/II study, eligible patients had mTNBC, measurable disease, and ≤2 prior systemic anticancer therapies in the metastatic setting. Patients were enrolled by number of prior systemic anticancer therapies (stratum 1: 0 vs stratum 2: 1-2) in the metastatic setting and further analyzed by tumor programmed death-ligand 1 (PD-L1) expression status. All patients received intravenous eribulin 1.4 mg/m2 on day 1 and day 8, plus intravenous pembrolizumab 200 mg on day 1, of 21-day cycles. The primary objectives were the safety, tolerability, and objective response rate (ORR) of this combination. Results: The study included 167 patients (phase Ib, n ¼ 7; phase II, n ¼ 160). The most common treatment-emergent adverse events were fatigue (66%), nausea (58%), peripheral sensory neuropathy (41%), alopecia (40%), and constipation (37%). ORRs were 25.8% [95% confidence interval (CI): 15.8-38.0] for stratum 1 (n ¼ 66) and 21.8% (95% CI: 14.2-31.1) for stratum 2 (n ¼ 101). Patients with PD-L1-positive tumors (combined positive score ≥1) had numerically higher ORR than those with PD-L1-negative tumors, particularly in stratum 1 [stratum 1: 34.5% (95% CI: 17.9-54.3) vs 16.1% (95% CI: 5.5-33.7); stratum 2, 24.4% (95% CI: 12.9-39.5) vs 18.2% (95% CI: 8.2-32.7)]. Conclusions: Eribulin plus pembrolizumab was generally well tolerated and showed promising antitumor activity in mTNBC. Efficacy outcomes appeared influenced by line of therapy and PD-L1 status.

Original languageEnglish (US)
Pages (from-to)3061-3068
Number of pages8
JournalClinical Cancer Research
Volume27
Issue number11
DOIs
StatePublished - Jun 1 2021

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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