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Eflapegrastim-Xnst Submitted by Spectrum Pharmaceuticals

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Eflapegrastim-Xnst Submitted by Spectrum Pharmaceuticals Anton F. Ehrhardt, PhD, VP Medical Affairs Spectrum Pharmaceuticals, Inc One Main St, 11th floor Cambridge, MA 02142 Phone: (617) 477-8091 Email: [email protected] Date of request: 31 August 2020 NCCN Guidelines Panel: Hematopoietic Growth Factors On behalf of Spectrum Pharmaceuticals, Inc., I respectfully request the NCCN Hematopoietic Growth Factors Panel review the enclosed data for inclusion of eflapegrastim-xnst (Rolontis®), a non-biosimilar long-acting G- CSF of noVel structure, as a recommendation for prophylaxis of febrile neutropenia and maintenance of scheduled dose deliVery (MGF-B). Specific Changes: 1. Addition of eflapegrastim-xnst as a recommendation for prophylaxis of febrile neutropenia and maintenance of scheduled dose deliVery (MGF-B) a. Dosing recommendation below listing of eflapegrastim-xnst: One dose of 13.2 mg (MGF-B) 2. Addition of eflapegrastim-xnst to the listing of Filgrastim, Pegfilgrastim and Tbo-filgrastim in table MGF- D (Toxicity Risks for Myeloid Growth Factors) FDA Clearance: Rolontis is undergoing FDA reView based on an original BLA#761148 for a proposed indication of: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. PDUFA for this reView is October 24th, 2020. Rationale: In support of the proposed change, data were generated in pre-clinical in-Vitro and animal model studies that indicated structure-related enhancement of potency, and increased concentrations in bone marrow compared to pegfilgrastim (Barrett 2020(reference 1)). Eflapegrastim is composed of a recombinant human G- CSF joined to an IgG4 Fc moiety Via a short polyethylene glycol linker. The Fc fragment increases the conjugate’s molecular weight/size sufficiently to minimize renal clearance and is thought to facilitate transcytosis and recycling of eflapegrastim via neonatal Fc receptors (FcRn) in the endothelium. Pre-clinical studies were followed by a clinical development series comprised of three phase 1 studies, a phase 2 dose-ranging study, and two phase 3 pivotal trials comparing eflapegrastim head-to-head with pegfilgrastim. Data from initial phase 1 studies were confirmed in a third trial (data on file, Shin 2013). A subsequent phase 2 randomized open-label study (Vacirca 2018) investigated the safety and efficacy of three weight-based doses of eflapegrastim (45, 135 and 270 µg/mL) in comparison to pegfilgrastim at its standard 6 mg/0.6 mL fixed dose (Barrett 2020(reference 3)). Based on these data a fixed dose was selected, and 643 total patients were randomized (314 patients to eflapegrastim and 329 to pegfilgrastim) in two pivotal trials (Schwartzberg 2020, Cobb 2020) comparing eflapegrastim (13.2 mg/0.6 mL) to pegfilgrastim (6 mg/0.6 mL) in patients with early One Main Street, 11th Floor • Cambridge, MA 02142 • Tel: 617.586.3900 www.sppirx.com • NASDAQ: SPPI stage breast cancer receiving treatment with docetaxel/cyclophosphamide. Both of the piVotal trials met their primary endpoints of achieving noninferior efficacy of eflapegrastim compared to pegfilgrastim (mean duration of severe neutropenia in cycle 1), while also demonstrating comparable safety. The following articles are submitted in support of this proposed change. 1. Barrett JA, et al. Eflapegrastim Enhanced Efficacy Compared to Pegfilgrastim in Neutropenic Rats Supports Potential for Same-Day Dosing. Exp Hematol. 2020; accepted for publication. 2. Shin KH, et al. Pharmacokinetic and Pharmacodynamic Properties of a New Long-Acting Granulocyte Colony-Stimulating Factor (HM10460A) in Healthy Volunteers. BioDrugs. 2013;27:149-158. 3. Barrett JA, et al. Justification for a Fixed Dose of Eflapegrastim, a Long-Acting G-CSF, in Patients Receiving Docetaxel-Cyclophosphamide Chemotherapy. J Clin Pharmacol. 2020;0(0):1-7. 4. Vacirca JL, et al. An Open Label, Dose-Ranging Study of Rolontis, a NoVel Long-Acting Myeloid Growth Factor, in Breast Cancer. Cancer Medicine. 2018;7(5):1660–1669. 5. Schwartzberg LS, et al. Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial. The Oncologist. 2020;25:1- 9. 6. Cobb PW, et al. A Comparison of Eflapegrastim to Pegfilgrastim in the Management of Chemotherapy- Induced Neutropenia in Patients with Early-Stage Breast Cancer Undergoing Cytotoxic Chemotherapy (RECOVER): A Phase 3 Study. Cancer Medicine. 2020;00:1–10. https://doi.org/10.1002/cam4.3227 Respectfully, Anton F. Ehrhardt One Main Street, 11th Floor • Cambridge, MA 02142 • Tel: 617.586.3900 www.sppirx.com • NASDAQ: SPPI .
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