Rolvedon (eflapegrastim-xnst) / Hanmi, Assertio - LARVOL DELTA

The counterparty to the technology transfer agreements for the Non-small cell lung cancer (NSCLC) drug "poziotinib" and the neutropenia treatment "rolontis" under Hanmi Pharmaceutica…has changed from U.S.-based Assertio Holdings to Indian pharmaceutical company Zydus Lifesciences. (Chosun Biz) - "Hanmi Pharmaceutical said on the 21st that it corrected its disclosure on key management matters for investment judgment related to poziotinib and rolontis and would change the counterparty to the technology transfer agreements from Assertio to Zydus. The change comes after Zydus acquired 100% equity in Assertio. Zydus will also assume the rights and obligations related to development and sales within the contracted territories for the two treatments that Assertio had held."

Licensing / partnership • Neutropenia • Non Small Cell Lung Cancer

CLO26-092: Real-World Use of Eflapegrastim in 14-Day Chemotherapy Cycles/Dose-Dense Regimens. (PubMed, J Natl Compr Canc Netw) - No abstract available

Journal • Real-world evidence

Real-World evidence of eflapegrastim (efla) usage in patients with gastrointestinal (GI) malignancies (AACR 2026) - "Background: Long-acting granulocyte colony-stimulating factors (GCSFs) such as efla and pegfilgrastim (peg) are routinely used to prevent neutropenia in patients (pts) with cancer undergoing neutropenia-inducing chemotherapy...Chemotherapy regimens included FOLFIRI (35% vs 21%) and FOLFOX (48% vs 34%)... Pts receiving chemotherapy for GI malignancies who were treated with efla were older and had a higher burden of comorbidities than those treated with peg. The incidence of FN was similar and low between treatments. Other AEs were also comparable between the two groups."

Clinical • HEOR • Real-world • Real-world evidence • Anal Carcinoma • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

CLO26-092: Real-World Use of Eflapegrastim in 14-Day Chemotherapy Cycles/Dose-Dense Regimens. (PubMed, J Natl Compr Canc Netw) - No abstract available

Journal • Real-world evidence

Real-World Use of Eflapegrastim in 14-Day Chemotherapy Cycles/Dose-Dense Regimens (NCCN 2026) - "Data beyond registration studies, which compared efla to pegfilgrastim (peg) in patients (pts) with breast cancer receiving docetaxel and cyclophosphamide, are limited...Chemotherapy regimens included FOLFOX (50% vs 15%), FOLFIRI (37% vs 9%), and anthracycline agents (26% each)... Pts receiving 14-day chemotherapy/dose-dense regimens for diverse cancer types who were treated with efla were older and tended to have a higher burden of comorbidities than those treated with peg. Incidence of FN was low and comparable between efla and peg. Rates of AEs were similar between groups."

Clinical • Real-world • Real-world evidence • Breast Cancer • Febrile Neutropenia • Neutropenia • Solid Tumor

Safety and Efficacy of Same-Day Administration of Eflapegrastim in Patients with Early-Stage Breast Cancer Receiving Chemotherapy. (PubMed, Oncologist) - "Eflapegrastim-xnst, administered same day as TC chemotherapy was effective and well tolerated evidenced by short time to neutrophil recovery and low incidence of FN, with an adverse event profile similar to that of next-day dosing."

Journal • Alopecia • Breast Cancer • Chemotherapy-Induced Neutropenia • Fatigue • Febrile Neutropenia • Hematological Disorders • Immunology • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

Effect of Granulocyte Colony Stimulating Factor (GCSF) on Survival in Patients with Acute Myeloid Leukemia (AML) (ASH 2024) - "The population was further divided into two groups, based on the receipt of GCSF (filgrastim, pegfilgrastim, lenograstim, eflapegrastim) within 6 months of diagnosis. Overall survival was also shorter for patients who received GCSF. GCSF should be used very diligently in AML cases."

Acute Myelogenous Leukemia • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Septic Shock

Hanmi Pharmaceutical is preparing to launch a new formulation of its severe neutropenia treatment biopharmaceutical Rolontis (Rolvedon in the U.S.) with a patient-tailored dosing regimen in the first half of next year. (Korea Biomedical Review)

Launch non-US • Chemotherapy-Induced Neutropenia

A Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients (ASPHO 2025) - "Updated preliminary data suggests eflapegrastim is a safe and effective growth factor in pediatric cancer treatment regimens."

Clinical • P2 data • PK/PD data • Febrile Neutropenia • Lymphoma • Neutropenia • Pediatrics • Solid Tumor • CD34

Eflapegrastim, a Long-Acting Granulocyte Colony–Stimulating Factor, Administered the Same Day as Chemotherapy in Patients With Early-Stage Breast Cancer: Results From a Multicenter, Open-Label Study (MBCC 2025) - P1, P3 | "Eflapegrastim—a novel, long-acting, recombinant human GCSF linked to human IgG4 Fc fragment—showed improved bone marrow residence vs pegfilgrastim that may allow for same-day dosing. Conclusion Eflapegrastim given on the same day as docetaxel and cyclophosphamide chemotherapy may reduce the time to ANC recovery and related complications in early-stage breast cancer. The AEs observed were consistent with those observed with other GCSF products."

Back Pain • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

Eflapegrastim, a long-acting GCSF, administered the same day as chemotherapy in patients with early-stage breast cancer: Results from a multicenter, open-label, study (SABCS 2024) - P1, P3 | "Eflapegrastim, via transcytosis and recycling, demonstrates increased bone marrow residence compared with pegfilgrastim, potentially improving its bioavailability following chemotherapy and allowing same-day dosing...Pts received subcutaneous eflapegrastim (single, fixed dose of 13.2 mg [3.6 mg GCSF]) 0.5 h ± 5 min post TC (intravenous docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2) The primary endpoint was the time to recovery of absolute neutrophil counts (ANC) from nadir to ≥ 1.5×109/L in C1... These findings suggest that administration of eflapegrastim on the same day as TC chemotherapy may be advantageous in reducing the time to ANC recovery and related complications in pts with ESBC. The AEs observed in this study were consistent with those generally observed in pts receiving TC and other GCSF products."

Clinical • Breast Cancer • Oncology • Solid Tumor

Assertio Announces Results of Rolvedon (eflapegrastim-xnst) injection Same-Day Dosing Clinical Study (GlobeNewswire) - P1 | N=59 | NCT04187898 | Sponsor: Spectrum Pharmaceuticals, Inc | "The results were presented as part of the San Antonio Breast Cancer....In this open-label, single-arm study (NCT04187898), conducted across 13 sites in the US, individuals received Rolvedon 30 minutes post chemotherapy for ESBC. Rolvedon demonstrated 1.8 days to neutrophil count recovery and a febrile neutropenia rate of 2%. Zero patients required the need for hospitalization and/or intervention for febrile neutropenia. No new safety signals were identified."

P1 data • Breast Cancer • Oncology • Solid Tumor

Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - P1 | N=59 | Completed | Sponsor: Spectrum Pharmaceuticals, Inc | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Ryzneuta for prevention of febrile neutropenia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Febrile Neutropenia • Hematological Disorders • Neutropenia

Comparative analysis of efficacy and safety profiles between conventional pegfilgrastim and its biosimilar agents in patients receiving cytotoxic chemotherapy: A systemic review and meta-analysis. (ASCO 2024) - "Growing evidence supports cost-effective biosimilars of pegfilgrastim as comparable in efficacy and safety. Eflapegrastim emerges as a promising alternative, demonstrating a clinically meaningful benefit over the conventional pegfilgrastim."

Retrospective data • Review • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Pain

Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Spectrum Pharmaceuticals, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

A PHASE 2 STUDY OF EFLAPEGRASTIM IN PEDIATRIC PATIENTS TREATED WITH MYELOSUPPRESSIVE CHEMOTHERAPY (ASPHO 2024) - "Preliminary data suggests eflapegrastim is a safe and effective long-acting myeloid growth factor in pediatric cancer treatment regimens. Eflapegrastim was generously supplied by Assertio."

Clinical • P2 data • Febrile Neutropenia • Lymphoma • Neutropenia • Pediatrics • Solid Tumor • CD34

A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Spectrum Pharmaceuticals, Inc | Trial completion date: Oct 2025 ➔ Oct 2027 | Trial primary completion date: Jul 2025 ➔ Oct 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Neutropenia • Oncology • Pediatrics • Solid Tumor

Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Spectrum Pharmaceuticals, Inc | N=90 ➔ 50 | Trial completion date: Jun 2025 ➔ Jul 2024 | Trial primary completion date: Dec 2024 ➔ Jul 2024

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

NEUTHREE: Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Eunseong Medical Foundation Good GANG-AN HOSPITAL | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2025 ➔ Jul 2025 | Initiation date: Aug 2023 ➔ Nov 2023 | Trial primary completion date: Jul 2024 ➔ Jan 2025

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • ER • HER-2

Assessing the Optimal Regimen: A Systematic Review and Network Meta-Analysis of the Efficacy and Safety of Long-Acting Granulocyte Colony-Stimulating Factors in Patients with Breast Cancer. (PubMed, Cancers (Basel)) - "For patients with breast cancer, lipegfilgrastim 6 mg and eflapegrastim 13.2 mg might be the most effective regimen among LA-G-CSFs. Higher doses of LA-G-CSF may enhance efficacy without causing additional SAEs."

Journal • Retrospective data • Review • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Initiation of phase 4 trial of 'Rolontis' by Hanmi Pharmaceutical... 3rd day dosing regimen study after chemotherapy (Health Korea News) - "Hanmi Pharmaceutical is starting a new follow-up study to expand the usage of Rolontis (Eflafegrastim, US product name: ROLVEDON), a new drug for the treatment of neutropenia. According to Clinicaltrials, a clinical information providing site operated by the National Institute of Health (NIH), Hanmi Pharmaceutical and Eunseong Medical Foundation Good Gangan Hospital showed the effect of administering 'Rolontis' on the third day after chemotherapy (NEUTHREE). A phase 4 clinical trial is being conducted to confirm. This clinical trial was conducted on breast cancer patients who experienced neutropenia despite administering 'Rolontis' the day after the first chemotherapy (24 hours later). This is to determine if the incidence of neutropenia can be reduced when the goal is to start next month and end in January 2025."

Trial status • Breast Cancer • Chemotherapy-Induced Neutropenia • Oncology

NEUTHREE: Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Eunseong Medical Foundation Good GANG-AN HOSPITAL

New P4 trial • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • ER • HER-2

FDA Approvals of Biologics in 2022. (PubMed, Biomedicines) - "We not only apply a quantitative analysis to this year's harvest, but also compare the efficacy of the Biologics with those authorized in previous years. On the basis of their chemical structure, the Biologics addressed fall into the following classes: monoclonal antibodies; antibody-drug conjugates; and proteins/enzymes."

FDA event • Journal • Review • Immunology • Infectious Disease • Novel Coronavirus Disease • Oncology

Eflapegrastim (Rolvedon) for prevention of chemotherapy-induced febrile neutropenia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia