Stimufend (pegfilgrastim-fpgk) / Fresenius Kabi - LARVOL DELTA

Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: University of Washington

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Embryonal Tumor • Germ Cell Tumors • Oncology • Solid Tumor • NF1

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2027 ➔ Dec 2026 | Trial primary completion date: Dec 2027 ➔ Dec 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: University of Washington | Initiation date: Sep 2025 ➔ Dec 2025

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Children's Oncology Group | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Embryonal Tumor • Germ Cell Tumors • Oncology • Solid Tumor • NF1

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Oct 2024

Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

SWOG S1826: Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma (clinicaltrials.gov) - P3 | N=994 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2025 ➔ Mar 2026

Trial completion date • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: University of Washington | Initiation date: Jun 2025 ➔ Sep 2025

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

S0533: Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Large Cell Carcinoma • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial primary completion date: Sep 2027 ➔ Dec 2027 | Trial completion date: Sep 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: University of Washington

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Demonstration of physicochemical and functional similarity between Stimufend (pegfilgrastim-fpgk) and Neulasta (pegfilgrastim): A comparative analytical assessment. (PubMed, PLoS One) - "The findings of this study provide robust evidence supporting the structural and functional biosimilarity between Stimufend® and Neulasta®."

Clinical • Journal • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Oncology

Changes in US payer biosimilar coverage policies of granulocyte colony-stimulating factor products (AMCP 2024) - "For filgrastim biosimilars, 84% of payers preferred Zarxio, whereas Neupogen, Nivestym, and Releuko were most commonly nonpreferred...For pegfilgrastim biosimilars, 62% of payers preferred Ziextenzo, 60% preferred Neulasta, and 55% preferred Fulphila, whereas Nyvepria, Fylnetra, and Stimufend were most commonly nonpreferred. Prefer- ence for Udenyca was split, with 45% of payers preferring this agent and 45% of payers listing it as nonpreferred... Payer policies for granulocyte colony stimu- lating factor biosimilars indicated that Neulasta has retained much of its preferred status, whereas Neupogen is often nonpreferred. In both cases, average time to policy addition was about 4 months after FDA approval. Further, pegfil- grastim policies had more updates to the preferred product status than filgrastim policies, possibly because of more pegfilgrastim biosimilars being approved and marketed."

"CMS grants Fresenius Kabi permanent, product-specific Q-Code for Stimufend® (pegfilgrastim-fpgk) https://t.co/5Dg9F5seah" (@NewsFromBW)

Stimufend (pegfilgrastim-fpgk) Now Available in the United States (Businesswire) - "Fresenius Kabi announced today the immediate availability in the U.S. of Stimufend^® (pegfilgrastim-fpgk), the company’s biosimilar to Neulasta® (pegfilgrastim), for use in patients at risk for febrile neutropenia, a common side effect of many anti-cancer medications."

Launch US • Chemotherapy-Induced Neutropenia • Oncology

Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults. (PubMed, Expert Rev Clin Immunol) - "Pharmacokinetic similarity of MSB11456 and US-licensed tocilizumab was demonstrated, with comparable immunogenicity and safety profiles, supporting MSB11455 as a biosimilar to US-licensed tocilizumab. The trial is registered at EudraCT, number 2019-003484-22."

Clinical • Journal • PK/PD data • IL6R

Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Stimufend (pegfilgrastim - fpgk) (Businesswire) - "Fresenius Kabi...announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved its biosimilar, Stimufend^® (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company expects to launch the product in a prefilled syringe early next year and in an on-body injector following FDA approval....Earlier this year, the company received the European Commission’s (EC) marketing authorization for Stimufend^® and it intends to launch its pegfilgrastim biosimilar in a prefilled syringe in Europe in the fall....The approval for Stimufend^® (pegfilgrastim - fpgk) is based on a review of a comprehensive data package and a totality of evidence that demonstrated a high degree of similarity with the reference product."

Biosimilar launch • Chemotherapy-Induced Neutropenia • Oncology

Pegfilgrastim Next As Fresenius Kabi Eyes Five Biosimilars In 2025 (Generics Bulletin - Informa) - "Fresenius Kabi has drawn up a roadmap to offering five biosimilar products by 2025, with a biosimilar to Amgen’s Neulasta (pegfilgrastim) set to rival competitors in the US and Europe later this year..."

Biosimilar launch • Neutropenia

Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta® in Healthy Subjects: a Randomized, Double-blind Trial. (PubMed, Clin Ther) - P1 | "Pharmacokinetic and pharmacodynamic equivalence of MSB11455 and the reference product was shown, with comparable immunogenicity, safety, and tolerability between treatments. The study supports the biosimilarity of MSB11455 to the reference product. ClinicalTrials.gov identifier: NCT03251248."

Clinical • Journal • PK/PD data

FDA accepts for review Fresenius Kabi’s BLA submission for pegfilgrastim biosimilar (Businesswire) - "Fresenius Kabi...announced today the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for MSB11455, the company’s pegfilgrastim biosimilar candidate for Neulasta®....Pegfilgrastim is used to reduce the incidence of infection associated with febrile neutropenia, a serious side effect of chemotherapy."

BLA • Neutropenia • Oncology

Fresenius : Kabi's regulatory submission for pegfilgrastim biosimilar accepted for review by EMA (Market Screener) - "The European Medicines Agency (EMA) has accepted for review Fresenius Kabi`s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)."

European regulatory • Neutropenia

Fresenius Kabi pegfilgrastim shows matching safety, immunogenicity (Center for Biosimilars) - "The immunogenicity results demonstrated noninferiority of MSB11455 based on the prespecified margins. Treatment-induced ADA-positive rates were 8.9% in the MSB11455 group and 9.5% in the reference product group."

Clinical • Neutropenia

Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta in healthy subjects: A randomized, double-blind trial. (PubMed, Pharmacol Res Perspect) - "Safety and tolerability were as expected for pegfilgrastim, and comparable between treatments. This study supports and strengthens the available evidence for the biosimilarity of MSB11455 to Neulasta ."

Clinical • Journal