Reference Detail

Ref Type

Journal Article

PMID

(33727258)

Authors

Tolaney SM, Kalinsky K, Kaklamani VG, D'Adamo DR, Aktan G, Tsai ML, O'Regan RM, Kaufman PA, Wilks ST, Andreopoulou E, Patt DA, Yuan Y, Wang G, Savulsky C, Xing D, Kleynerman E, Karantza V, Diab S

Title

Eribulin Plus Pembrolizumab in Patients with Metastatic Triple-Negative Breast Cancer (ENHANCE 1): A Phase Ib/II Study.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Clinical cancer research : an official journal of the American Association for Cancer Research	27	11	2021 Jun 01	3061-3068	Clin Cancer Res

URL

Abstract Text

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.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.The study included 167 patients (phase Ib, n = 7; phase II, n = 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 = 66) and 21.8% (95% CI: 14.2-31.1) for stratum 2 (n = 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)].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.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 positive	triple-receptor negative breast cancer	predicted - sensitive	Eribulin + Pembrolizumab	Phase Ib/II	Actionable	In a Phase I/II trial, Keytruda (pembrolizumab) and Eribulin combination therapy demonstrated safety and clinical activity in patients with metastatic triple-negative breast cancer, patients with CD274 (PD-L1)-positive tumors achieved better objective response rate (28.4% vs 17.3%), median progression-free survival (4.2 vs 3.9 months), and overall survival (16.3 vs 15.2 months) compared to patients with CD274 (PD-L1)-negative tumors (PMID: 33727258; NCT02513472).	33727258