SCIENTIFIC PROGRAMME PS06 Parallel Session 06: Challenges of Hemostasis in Cancer Patients
29-Jun-2018 09:05 10:35
Abstract: PS026 EFLAPEGRASTIM IS SAFE AND EFFECTIVE IN REDUCING SEVERE NEUTROPENIA IN PATIENTS RECEIVING MYELOSUPPRESSIVE CHEMOTHERAPY IN A PHASE 3 RANDOMIZED, CONTROLLED TRIAL COMPARED TO PEGFILGRASTIM (ADVANCE) Introduction: Eflapegrastim is a novel investigational biologic comprised of recombinant human G-CSF covalently linked to the human immunoglobulin G4FC fragment using proprietary LAPSCOVERY™ technology.
Objectives This study was a randomized, Phase 3 study to demonstrate the non-inferiority (NI) of eflapegrastim to pegfilgrastim in patients receiving chemotherapy for breast cancer.
Methods Patients with Stage I to Stage IIIA breast cancer were treated with a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL or pegfilgrastim (6 mg) in a 1:1 ratio on Day 2 of each of four cycles following adjuvant/neo-adjuvant docetaxel and cyclophosphamide (TC) on Day 1. The primary endpoint was to demonstrate non-inferiority of eflapegrastim as measured by the mean duration of severe neutropenia (DSN) in Cycle 1 with NI margin of <0.62 day.
Results In a total of 406 intent-to-treat patients (randomized to 196 eflapegrastim; 210 pegfilgrastim), median age was 61 years (range 24 to 84 years); mean (SD) DSN was 0.19 (0.478) days for eflapegrastim and 0.34 (0.668) days for pegfilgrastim, demonstrating the non-inferiority (95% CI of ?DSN: [-0.260, -0.035]; p<0.0001). The non-inferiority of eflapegrastim for DSN was maintained across all 4 cycles. The adverse events observed in ≥10% of patients were similar across both arms and were mainly hematologic including neutropenia, decreased lymphocytes, anemia and leukopenia.
Conclusions Eflapegrastim, a novel long acting G-CSF was non-inferior to pegfilgrastim in the reduction of DSN in Cycles 1-4, in breast cancer patients treated with TC. Eflapegrastim was safe and well-tolerated with a similar safety profile to pegfilgrastim.
Co-authors L. Schwartzberg 1, G. Bhat 2, J. Peguero 3, R. Agajanian 4, J. Bharadwaj 5, A. Restrepo 6, O. Hlalah 7, I. Mehmi 8, Z. Yang 9, P. Cobb 10 1University of Tennessee Health Sciences Center, Division of Hematology/Oncology, Memphis, USA 2Spectrum Pharmaceuticals- Inc., Biostatistics- Data Management- and Medical Writing, Irvine, USA 3Oncology Consultants PA, Department of Research, Houston, USA 4The Oncology Institute of Hope and Innovation, Hematology/Oncology, Downey, USA 5Pacific Cancer Medical Center, Hematologic Oncology, Anaheim, USA 6Texas Oncology, Medical Oncology, McAllen, USA 7Bond Clinic, Oncology and Hematology, Winter Haven, USA 8Edwards Comprehensive Cancer Center, Hematology/Oncology, Huntington, USA 9Spectrum Pharmaceuticals- Inc., Clinical Development, Irvine, USA 10Frontier Cancer Center, Hematology/Oncology, Billings, USA
Just to provide a bit more specificity: the Rolontis Phase 3 data abstract will be published online by ASCO on May 16th. (Not quite as good as presenting at the actual conference, I imagine). The MASCC oral presentation is June 28-30.