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

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

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

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

Spectrum Pharmaceuticals Reports First Quarter 2023 Financial Results and Corporate Update (Businesswire) - "Total cost of sales was $1.1 million for the quarter ended March 31, 2023, and consisted primarily of royalties associated with net sales of ROLVEDON, stability testing and packaging costs....Research and development expenses increased for the three months ended March 31, 2023 by $1.2 million to $5.4 million as compared to the comparable period ended March 31, 2022. The current period had decreased personnel expenses of $5.7 million related to the reduction in workforce during the strategic restructuring that began in January 2022 and decreased program activities of $5.0 million for poziotinib. These period over period decreases were offset by the reversal of an $11.2 million ROLVEDON drug substance accrual during the quarter ended March 31, 2022, which was a concession provided by Hanmi for drug substance which had been accrued during 2021 and is no longer payable."

Commercial • Sales • Oncology

Assertio Holdings, Inc. to Acquire Spectrum Pharmaceuticals, Inc. in All Stock and CVR Transaction (GlobeNewswire) - "Assertio Holdings, Inc...and Spectrum Pharmaceuticals, Inc...announced that they have entered into a definitive agreement pursuant to which Assertio will acquire all outstanding shares of Spectrum in an all-stock and contingent value rights ('CVR') transaction....Subject to adjustments, each CVR shall represent the right to receive $0.10 payable upon ROLVEDON net sales (less certain deductions) achieving $175 million during the calendar year ending December 31, 2024, and $0.10 payable upon ROLVEDON net sales (less certain deductions) achieving $225 million during the calendar year ending December 31, 2025....Enhanced IP Portfolio: ROLVEDON’s intellectual property protection is anticipated to extend through 2036, complementing Assertio’s portfolio of traditional and non-traditional IP protection, including assets with protection extending beyond 2040 and plans to secure additional protections on existing assets."

M&A • Oncology

Hanmi’s neutropenia drug Rolontis marks $10-million US sale in 1st year (Korea Biomedical Review) - "Spectrum Pharmaceuticals (SPPI), the U.S. partner of Hanmi Pharm, recorded $10.1 million (13 billion won) in sales in the first year of releasing Rolontis (eflapegrastim with the U.S. product name of Rolvedon), a neutropenia treatment, in the U.S. market. On Wednesday (local time), the company unveiled its sales performance in the fourth quarter of 2022 and the whole year."

Sales • Chemotherapy-Induced Neutropenia • Neutropenia • Oncology

[VIRTUAL] Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia after Same-Day Dosing of Eflapegrastim in Patients with Breast Cancer Receiving Docetaxel and Cyclophosphamide (NCT04187898) (ASH 2020) - P1 | "Target Accrual: 45 patients (15 subjects/arm). Enrollment began in April 2020."

Clinical • P1 data • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Transplantation

Spectrum Pharmaceuticals Receives Permanent J-Code for ROLVEDON (eflapegrastim-xnst) Injection (J1449) from U.S. Centers for Medicare & Medicaid Services (Businesswire) - "Spectrum Pharmaceuticals, Inc....announced today that a permanent J-code, J1449, has been issued for ROLVEDON (eflapegrastim-xnst) Injection by the U.S. Centers for Medicare & Medicaid Services (CMS) effective as of April 1, 2023."

Reimbursement • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology

"$SPPI Spectrum Pharmaceuticals Receives Permanent J-Code for ROLVEDON™ (eflapegrastim-xnst) Injection (J1449) from U.S. Centers for Medicare & Medicaid Services https://t.co/VFj43GKyAZ" (@stock_titan)

Medicaid • Medicare • Reimbursement • US reimbursement

Eflapegrastim Versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies. (PubMed, Cancer Res Treat) - "Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G CSF equivalent]) compared to pegfilgrastim (6 mg based on G CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide...There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations. This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population."

Journal • P3 data • Breast Cancer • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Eflapegrastim-xnst. (PubMed, Am J Health Syst Pharm) - No abstract available

Journal