30 Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Early- Stage Breast Cancer (ESBC) Receiving Docetaxel and Cyclophosphamide

Publication
Article
Miami Breast Cancer Conference® Abstracts Supplement38th Annual Miami Breast Cancer Conference® - Abstracts
Volume 35
Issue suppl 1
Pages: 20

Lee S. Schwartzberg, MD1;Lyndah K. Dreiling, MD2; Jawad Francis, MD3; Nishan Tchekmedyian, MD4; Osama Hlalah, MD5; Manuel Modiano, MD6; Gajanan Bhat, PhD2; Francois Lebel, MD2; Shanta Chawla, MD2

1West Cancer Center, Germantown, TN.

2Spectrum Pharmaceuticals, Inc, Irvine, CA.

3Mercy Health Youngstown, Youngstown, OH.

4Pacific Shores Medical Group, Huntington Beach, CA.

5Bond & Steele Clinic, PA, Winter Haven, FL.

6Arizona Clinical Research Center, Tucson, AZ.

Background

Eflapegrastim (Efla) is a long-acting granulocyte colony-stimulating factor (G-CSF), produced by covalent conjugation of a human GCSF analogue and a human immunoglobulin G4 Fc fragment, linked via a short polyethylene glycol linker. Currently available G-CSFs are administered 24 hours after chemotherapy. In docetaxel and cyclophosphamide (TC)–induced neutropenia in rats, the longer marrow residence time of Efla compared with pegfilgrastim translated into shorter duration of neutropenia when administered on the same day as TC. Data from the interim safety analysis in patients receiving Efla on the same day as chemotherapy are presented.

Materials and Methods

This is a randomized, schedule-finding, multicenter study (NCT04187898) evaluating same-day administration of 13.2 mg/0.6 mL Efla following intravenous infusion of docetaxel (75 mg/m2) and cyclophosphamide (600 mg/m2) in patients with ESBC. Patients were randomized to receive Efla 0.5 hours (Arm 1), 3 hours (Arm 2), and 5 hours (Arm 3) after TC. The primary end point is duration of grade 4 neutropenia (DSN) in cycle 1. The secondary end points include incidence of grade 3 febrile neutropenia (FN), pharmacokinetics, and safety in cycle 1. At the interim safety evaluation, an arm would be stopped if 1 or more patients experienced grade 4 DSN for more than 1 day.

Results

The interim evaluation, per protocol, included 9 patients (3 in each arm). In Arm 1, 1 of 3 patients had grade 4 neutropenia for 1 day without FN. In Arm 2, 1 of 3 patients had grade 4 neutropenia for 2 days and FN for 1 day with sepsis. In Arm 3, 1 of 3 patients had grade 4 neutropenia for 2 days and FN for 1 day, and another patient had grade 4 neutropenia for 1 day without FN. All 9 patients reported at least 1 adverse event (AE). Related grade 3 AEs included bone pain in 1 patient (arm 2) and lymphocyte count decreased in 1 patient (arm 3). There were no serious AEs related to Efla.

Conclusions

Efla may provide similar efficacy when administered on the same day, rather than next day, following TC. At interim evaluation, Arm 1 had no grade 4 neutropenia lasting more than 1 day. Enrollment in Arms 2 and 3 was discontinued because of the presence of grade 4 neutropenia that lasted more than 1 day and the overall safety profile. Enrollment is ongoing in Arm 1.

Articles in this issue

1 The Tolerance of CREATE-X Capecitabine Dosing in a United States TNBC Patient Population
1 The Tolerance of CREATE-X Capecitabine Dosing in a United States TNBC Patient Population
6 Survival Benefit of Eribulin, But Not Capecitabine, for Metastatic Breast Cancer Is Associated With Baseline Absolute Lymphocyte Count in Peripheral Blood
6 Survival Benefit of Eribulin, But Not Capecitabine, for Metastatic Breast Cancer Is Associated With Baseline Absolute Lymphocyte Count in Peripheral Blood
7 Evaluation of the 21-Gene Recurrence Score (RS) Assay Results Following Successful Intraoperative Radiation Therapy (IORT) Treatment of Patients With Early-Stage Breast Cancer
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13 Real-world Treatment Patterns and Tumor Response of Palbociclib Plus an Aromatase Inhibitor for Metastatic Breast Cancer: Flatiron Database Analysis
13 Real-world Treatment Patterns and Tumor Response of Palbociclib Plus an Aromatase Inhibitor for Metastatic Breast Cancer: Flatiron Database Analysis
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25 A Retrospective Cohort Study of Demographic, Clinical, and Treatment Characteristics of Patients With Metastatic Breast Cancer Who Have Received PARP Inhibitors
25 A Retrospective Cohort Study of Demographic, Clinical, and Treatment Characteristics of Patients With Metastatic Breast Cancer Who Have Received PARP Inhibitors
28 Primary Outcome Analysis of Invasive Disease-Free Survival for monarchE: Abemaciclib Plus Adjuvant Endocrine Therapy for High-Risk Early Breast Cancer
28 Primary Outcome Analysis of Invasive Disease-Free Survival for monarchE: Abemaciclib Plus Adjuvant Endocrine Therapy for High-Risk Early Breast Cancer
30 Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Early- Stage Breast Cancer (ESBC) Receiving Docetaxel and Cyclophosphamide
30 Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Early- Stage Breast Cancer (ESBC) Receiving Docetaxel and Cyclophosphamide
35 Decreased Epithelial Mesenchymal Transition Process After AGTR-1 Gene Edition By Crispr/Cas9, Losartan, and PARP Inhibitor Treatment In Breast Cancer Cell Line
35 Decreased Epithelial Mesenchymal Transition Process After AGTR-1 Gene Edition By Crispr/Cas9, Losartan, and PARP Inhibitor Treatment In Breast Cancer Cell Line
37 Treatment Outcomes Using Neoadjuvant Chemotherapy for HER2-Positive Breast Cancer in African American and Hispanic Women
37 Treatment Outcomes Using Neoadjuvant Chemotherapy for HER2-Positive Breast Cancer in African American and Hispanic Women
42 The United States Retrospective Claims Database Analysis of Demographic, Clinical, and Treatment Characteristics of Metastatic Breast Cancer Patients receiving Olaparib
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43 Lobular Cancer Responsiveness to Chemotherapy Is Equivalent to That of Ductal Cancer With Similar Genomic Profiles: An NCDB Analysis
43 Lobular Cancer Responsiveness to Chemotherapy Is Equivalent to That of Ductal Cancer With Similar Genomic Profiles: An NCDB Analysis
44 Drivers of Oncologist Treatment Selection in HR+/HER2- Metastatic Breast Cancer
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