Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche - LARVOL DELTA

IMPACT OF CD34⁺ CELL DOSE AND GROWTH FACTOR SUPPORT ON EARLY MORBIDITY AND NON-RELAPSE MORTALITY AFTER AUTOLOGOUS STEM CELL TRANSPLANT FOR LYMPHOMA (EBMT 2026) - "33% of patients received plerixafor and/or an additional cycle of cytarabine or cyclophosphamide to mobilise progenitor cells. We did not demonstrate a significant association between CD34+ dose in ASCT and 180-day NRM. CD34+ doses <4×10⁶/kg were associated with a higher rate of ICU admission and a composite adverse outcome. We found similar clinical outcomes with pegfilgrastim compared with filgrastim."

CNS Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Transplantation

Final Results of a Phase I/II Trial of Carfilzomib + R-CHOP for Frontline Treatment of Patients with Non-Germinal Center Diffuse Large B-Cell Lymphoma (DLBCL) (ASH 2023) - "All Pts received pegfilgrastim and zoster prophylaxis. KR-CHOP can be delivered safely, without excess cardiac toxicity or peripheral neuropathy. The superior PFS and OS rates for Pts with non-GC DLBCL vs. controls receiving R-CHOP are encouraging but should be interpreted with caution due to inherent selection bias in clinical trial populations."

Clinical • P1/2 data • Anemia • B Cell Lymphoma • Cardiovascular • Congestive Heart Failure • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Heart Failure • Hematological Malignancies • Herpes Zoster • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Non-Hodgkin’s Lymphoma • Plasmacytoma • Pulmonary Disease • Thrombocytopenia

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 | Recruiting | Sponsor: University of Washington | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Safety and Efficacy of G-CSF with Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia: A Subgroup Analysis of the Phase II Trial of Venetoclax in Combination with Cladribine, Idarubicin, and Cytarabine (ASH 2024) - P2 | "The trial allowed treating physicians to use filgrastim 300–480 µg daily for prolonged neutropenia or neutropenic fever; a trial amendment integrated pegfilgrastim at a dose of 6 mg SQ once between D5–9 of each cycle...Sixteen (18%) patients had FLT3-ITD — 8 (9%) received gilteritinib and 1 (1%) received midostaurin...FLT3-ITD AML was associated with delayed count recovery, likely due to concurrent TKI use. G-CSF use had no impact on the incidence of AML relapse."

Clinical • Combination therapy • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • ASXL1 • BCOR • BCR • FLT3 • KRAS • RUNX1 • SF3B1 • SRSF2 • STAG2 • U2AF1 • ZRSR2

From Aortitis to Sweet's: The Immune Spectrum of G-CSF Adverse Events. (PubMed, Semin Arthritis Rheum) - "Exogenous G-CSF can precipitate a coherent spectrum of immune-mediated toxicity with distinct, clinically actionable timing windows: vascular events peak 7-15 days after pegfilgrastim, whereas cutaneous, articular, and pulmonary manifestations arise within 2-7 days. Recognition hinges on temporal linkage, imaging/histology, and exclusion of mimics. Management is phenotype-aware-drug withdrawal ± short glucocorticoids, formulation switching for CPPD, and targeted IL-6 blockade in selected refractory aortitis-allowing preservation of hematologic benefits while minimizing immune toxicity. Prospective surveillance and structured re-exposure studies (including formulation tailoring) are priorities to move from signal detection to prevention."

Adverse events • Journal • Review • Chemotherapy-Induced Neutropenia • Dermatitis • Dermatology • Hematological Disorders • Immunology • Neutropenia • Oncology • Pyoderma Gangrenosum • Respiratory Diseases • Rheumatology • Vasculitis • CSF2

Clinical outcome of 50 patients treated with eribulin for soft tissue sarcoma: a single-institute retrospective study. (PubMed, Jpn J Clin Oncol) - "Eribulin demonstrated favorable tolerability and durable disease control across diverse patient subgroups, including elderly and comorbid patients who are often ineligible for anthracycline therapy. Although no significant prognostic factors were identified, bi-weekly dosing and two-administration/2-week rest schedules were feasible, with the latter offering the advantage of pegfilgrastim support. These findings support the integration of eribulin into individualized treatment strategies for advanced STS and highlight the need for prospective studies to refine patient selection and optimize dosing approaches."

Clinical data • Journal • Retrospective data • Hematological Disorders • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Claudin- 6 (CLDN6) is a therapeutic target in ovarian cancer (OC): Emerging results from the CATALINA 1 (CAT1) study (ESMO 2025) - P1 | "For all OC: median prior lines 3 (1-9); 73% received prior bevacizumab, 67% prior PARP inhibitors, and 11% prior mirvetuximab. OC pts received doses 3.0 mg/kg (11) with doses ≥3.0 mg/kg given with prophylactic pegfilgrastim (peg)...TORL-1-23 was generally well tolerated with an acceptable safety profile. These proof-of-concept data support further evaluation of TORL-1-23 in larger, registration studies that are now ongoing."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN6

Bone Marrow Colony Stimulating Factors (CSF) and Stem Cell Therapy as Medical Countermeasures (MCM) for Treatment of Hematopoietic-Acute Radiation Syndrome: A Systematic Review. (PubMed, Disaster Med Public Health Prep) - "While studies looking at efficacy of CSFs given after 24 hours were limited, 2 studies included in this review showed that delayed administration of CSFs up to 120 hours may be beneficial compared to no treatment. Lack of standardization in experimental study design (e.g. radiation doses, animal species, interventions) between studies prevented direct comparisons using meta-analytic statistical approach."

Journal • Review

Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

Trial completion • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Evaluation of Pegfilgrastim Use Following Ambulatory Autologous Hematopoietic Stem Cell Transplant with Melphalan Conditioning (TCT-ASTCT-CIBMTR 2026) - "Ambulatory Melphalan ASCT followed by pegfilgrastim administration did not significantly impact duration of grade 4 neutropenia and resulted in shorter hospital stays. Incidence of febrile neutropenia and IV antibiotic use were reduced compared to Day +5 GCSF group. Additional data to be presented."

Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Transplantation

Efficacy of pegfilgrastim in preventing febrile neutropenia during DCF chemotherapy for esophageal cancer: A systematic review and meta-analysis. (PubMed, J Oncol Pharm Pract) - "BackgroundEsophageal cancer remains a leading cause of cancer-related mortality worldwide, with docetaxel, cisplatin, and fluorouracil (DCF) chemotherapy being a standard treatment option for locally advanced disease...Pegfilgrastim was also associated with lower rates of severe neutropenia and shorter hospital stays, with no significant increase in adverse events.ConclusionsIn our study, Pegfilgrastim prophylaxis significantly reduces FN risk, severe neutropenia, and hospital stays in esophageal cancer patients receiving DCF chemotherapy, without increasing major complications. These findings support its routine use in this population, though further prospective randomized trials are needed to optimize dosing strategies and confirm long-term benefits."

Journal • Retrospective data • Review • Chemotherapy-Induced Neutropenia • Esophageal Cancer • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Squamous Cell Carcinoma

Phase I, two-part, multicenter first-in-human (FIH) study of TORL-1-23: A novel claudin 6 (CLDN6) targeting antibody drug conjugate (ADC) in patient with advanced solid tumors (ESMO 2024) - P1 | "Part 2 enrolled 20 pts with ovarian (n=11), endometrial (n=4), NSCLC (n=4), and testicular (n=1) cancers at 2.4 mg/kg (n=12) and 3.0 mg/kg (n=8) with pegfilgrastim. TORL-1-23 is well tolerated with promising preliminary antitumor activity in heavily-pretreated pts with CLDN6-expressing ovarian, endometrial, and testicular cancers. Dose expansion is ongoing at doses of 2.4mg/kg and 3.0mg/kg in CLDN6+ NSCLC and ovarian cancer, and CLDN6-low expressing tumors."

Clinical • Metastases • P1 data • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN6

Long-Term Follow-up and updated analysis from S0221, Comparing Alternative Dose-Schedules of Adjuvant Anthracycline/Taxane Therapy in High-Risk Early Breast Cancer. (SABCS 2024) - " S0221 investigated weekly (arms 2 and 4) doxorubicin (A)/cyclophosphamide (C) + granulocyte colony stimulating factor (GCSF; filgrastim or pegfilgrastim) versus (vs.) every 2 weeks (Q2W) (arms 1 and 3) schedule AC, followed by paclitaxel (P) given Q2W or weekly for 12 weeks as post-operative adjuvant therapy in node-positive or high-risk node-negative breast cancer. As there were no significant outcome differences in DFS or OS between the studied schedules with extended follow-up in the original cohort or in the additional 578 patients treated on the revised protocol, either paclitaxel schedule may be recommended, with selection based on toxicity, cost, or patient preference rather than efficacy. [AA1]Character limit allowed 3400"

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Plinabulin to shorten neutropenia and improve quality of life peri-autologous hematopoietic cell transplant. (ASCO 2023) - P2 | "To decrease the period of myelosuppression and obligate neutropenia after high dose melphalan with autologous hematopoietic stem cell transplantation (AHCT) for patients with multiple myeloma, we studied the addition of plinabulin to standard growth factors. To achieve the primary objective of reducing the duration of absolute neutropenia post AHCT, 40mg of intravenous plinabulin was given 1-3 hours after stem cell infusion (Day 0) with pegfilgrastim on Day +1 in this pilot trial (NCT05130827)... Plinabulin appears well tolerated without additional major toxicities post AHCT and provided a high WBC on Day +2 and decreased rate of neutropenic fever. Plinabulin PK, quality of life data, and PROs will be presented. Adjusting the schedule of plinabulin to later post AHCT pre engraftment may further shorten the duration of neutropenia using this novel mechanism of action."

HEOR • Bone Marrow Transplantation • Cardiovascular • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Hypertension • Immune Modulation • Multiple Myeloma • Neutropenia • Oncology • Solid Tumor • Transplantation • CD34

Effectiveness and safety of pegylated filgrastim (Pelgraz®) for the prevention of febrile neutropenia during cancer chemotherapy in all-day practice in Germany. (PubMed, Support Care Cancer) - "Pegfilgrastim (Pelgraz®) treatment appeared to be effective and safe in all-day practice."

Journal • Observational data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Pain • Solid Tumor

Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: Abramson Cancer Center at Penn Medicine | Initiation date: Nov 2025 ➔ Apr 2026

Trial initiation date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Successful Treatment of Granulocyte Colony-Stimulating Factor-Related Aortitis in Prostate Cancer. (PubMed, IJU Case Rep) - "A 68-year-old male with castration-resistant prostate cancer initiated docetaxel therapy...After switching from pegfilgrastim to filgrastim, the patient completed eight treatment cycles without recurrence. In patients who develop fever and elevated inflammatory markers following granulocyte colony-stimulating factor administration, granulocyte colony-stimulating factor-related aortitis should be considered in the differential diagnosis."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

Study of Plinabulin and Pegfilgrastim in People With Multiple Myeloma Undergoing an Autologous Hematopoietic Stem Cell Transplant (AHCT) (clinicaltrials.gov) - P2 | N=17 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial primary completion date: Nov 2025 ➔ Nov 2026 | Trial completion date: Nov 2025 ➔ Nov 2026

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Transplantation • CD34

RMS13: Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy (clinicaltrials.gov) - P2 | N=115 | Active, not recruiting | Sponsor: St. Jude Children's Research Hospital | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial primary completion date • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Efbemalenograstim alfa significantly reduces incidence of incidence of severe chemotherapy-induced neutropenia in later cycles: Results of a meta analysis (SABCS 2025) - " ISN rates from four cycles from phase III trials of efbemalenograstim alfa and three different chemotherapy regimens, docetaxel + cyclophosphamide (TC) (Trial 1), epirubicin + cyclophosphamide (EC) (Trial 2), and high myelotoxic docetaxel + doxorubicin (TA) (Trial 3 + historic pegfilgrastim and filgrastim comparative data) were evaluated. Across studies, non-PEGylated efbemalenograstim alfa has demonstrated equivalent or lower incidence rates of severe neutropenia (grade 4, ANC <0.5 × 109/L) during the first cycle of three types of chemotherapy (TC, EC and TA) and importantly, significantly lower rates in later cycles when compared to pegfilgrastim and filgrastim. These findings demonstrate that efbemalenograstim alfa may be more effective at preventing severe, life-threatening neutropenia at later chemotherapy cycles, which has meaningful implications for real-world breast cancer patients that are likely to receive chemotherapy for longer durations."

Retrospective data • Breast Cancer

Long-term safety in breast cancer patients receiving doxorubicin-cyclophosphamide chemotherapy with secondary G-CSF prophylaxis: A single-centre prospective study (SABCS 2025) - "Secondary G-CSF (filgrastim or pegfilgrastim) was administered at physician discretion to prevent dose reductions or delays. In this real-world cohort, secondary G-CSF prophylaxis during q3-weekly AC chemotherapy was not associated with significant differences in all-cause mortality between groups. No secondary hematological malignancies were observed. These results support the liberaluse of secondary G-CSF in curative-intent regimens to prevent delays or reductions in dose intensity."

Clinical • Breast Cancer • Oncology • Solid Tumor

Glucocorticoids rarely required in granulocyte colony-stimulating factor-associated large-vessel vasculitis: Japanese cancer centre cohort. (PubMed, Rheumatology (Oxford)) - "Glucocorticoid-sparing management of G-CSF-associated LVV may be a safe and effective approach."

Journal • Breast Cancer • Hepatology • Liver Failure • Nephrology • Oncology • Renal Disease • Solid Tumor • Vasculitis

Rate of Acute Rejection in Kidney Transplant Patients Receiving Filgrastim versus Pegfilgrastim (ASHP 2025) - No abstract available

Clinical • Transplant Rejection • Transplantation

Effectiveness of Pegfilgrastim in Interval-Compressed VDC-IE Chemotherapy for Ewing Sarcoma (ASHP 2025) - No abstract available

Ewing Sarcoma • Sarcoma • Solid Tumor

Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P1 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma