Spectrum Pharmaceutecals Inc (SPPI)

[Ville]

Yes, but only online - so not really meaningful for the ASCO community.

Abstract at MASCC is out: no superiority! But good non-inferiority results. So the second study with smaller numbers should be positive.

https://masccmeeting.org/2018/abstracts/interactive-programm#.WutsykHD99A

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