AiDuo (mecapegfilgrastim) / Jiangsu Hengrui Pharma - LARVOL DELTA

Renaissance: Reverse Triple Negative Immune Resistant Breast Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Renaissance: Reverse Triple Negative Immune Resistant Breast Cancer (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Fudan University | N=30 ➔ 70 | Trial completion date: Mar 2023 ➔ Mar 2027 | Trial primary completion date: Dec 2022 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Renaissance: Reverse Triple Negative Immune Resistant Breast Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fudan University | Initiation date: Oct 2021 ➔ Apr 2022

Trial initiation date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Renaissance: Reverse Triple Negative Immune Resistant Breast Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fudan University | Initiation date: Apr 2022 ➔ Jun 2022

Trial initiation date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Renaissance: Reverse Triple Negative Immune Resistant Breast Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Fudan University | N=20 ➔ 30

Enrollment change • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Musculoskeletal pain, neutrophil recovery kinetics, and exploratory immune-profiling with telpegfilgrastim versus other long-acting G-CSFs in breast cancer: TELEGRAM (ESMO 2026) - "Patients received telpegfilgrastim 2 mg (24 h post-chemo) or investigator-selected pegfilgrastim, mecapegfilgrastim or efbemefilgrastim (24–48 h post-chemo). ANC recovery kinetics were inversely associated with IL-4 on Day 3 (p=0.023) and positively linked to IL-17 on Day 7 (p=0.017).Conclusions In this exploratory analysis, telpegfilgrastim significantly reduced MSP incidence and severity compared to other long-acting G-CSFs, with comparable efficacy in CIN prevention and a distinct GI-sparing safety profile. This study also provides hypothesis-generating evidence that G-CSF-induced hematopoietic recovery is modulated by the underlying immune microenvironment (e.g., IL-4 and IL-17 axes)."

Breast Cancer • Chemotherapy-Induced Neutropenia • Oncology • Solid Tumor • IL10 • IL17A • IL4

Safety and efficacy of mecapegfilgrastim plus alltrans retinoic acid and azacitidine for higherrisk myelodysplastic syndromes (ChiCTR) - P2 | N=202 | Not yet recruiting | Sponsor: Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University); Jiangsu Province Hospital (The First Affiliated Hospital wi

New P2 trial • Hematological Malignancies • Myelodysplastic Syndrome • Neutropenia • Oncology

Comparative efficacy and safety of four long-acting granulocyte colony-stimulating factors for primary prophylaxis in patients with breast cancer: a prospective observational cohort study in China. (PubMed, EClinicalMedicine) - "Patients received subcutaneous pegfilgrastim, mecapegfilgrastim, telpegfilgrastim, or efbemalenograstim alfa once per cycle per clinical practice...Larger prospective studies are needed to confirm these exploratory findings. None."

Journal • Observational data • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Leukopenia • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

Comparative efficacy and safety of etoposide plus PEG-rhG-CSF versus etoposide plus G-CSF for haematopoietic stem cell mobilisation in patients with multiple myeloma and lymphoma. (PubMed, Front Oncol) - "In particular, direct comparisons between mecapegfilgrastim and recombinant human G-CSF (rhG-CSF) in this setting are lacking. High-dose VP-16 combined with PEG-rhG-CSF demonstrated superior efficacy, safety, and procedural efficiency compared with high-dose VP-16 plus rhG-CSF. These findings suggest that this regimen represents a promising and potentially preferable alternative for haematopoietic stem cell mobilisation in patients with multiple myeloma or lymphoma."

Journal • Chemotherapy-Induced Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Oncology • Transplantation • CD34

Clinical Study and Economic Evaluation of High-Dose Etoposide Combined with Mecapegfilgrastim for Autologous Peripheral Blood Stem Cell Mobilization in Patients with Lymphoma (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi) - "Mobilizing peripheral blood stem cells in lymphoma patients with a single high-dose of etoposide combined with mecapegfilgrastim is effective, safe and cost-effective."

HEOR • Journal • Allergy • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Musculoskeletal Pain • Oncology • Pain • Transplantation • CD34

Real-world effectiveness of mecapegfilgrastim for prophylaxis in patients with breast cancer receiving 2-weekly and 3-weekly chemotherapy in China. (PubMed, BMC Cancer) - "Mecapegfilgrastim was associated with a low incidence of FN and manageable safety profiles in patients with breast cancer receiving 3-weekly or 2-weekly chemotherapy. Nevertheless, further studies with larger sample sizes are warranted to confirm these findings."

Journal • Real-world evidence • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Efficacy and Safety of Mecapegfilgrastim versus rhG-CSF for Peripheral Blood Stem Cell Mobilization in Healthy Donors: A Comparative Study (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi) - "In healthy donor PBSC mobilization, Mecapegfilgrastim is non-inferior to rhG-CSF, offers superior promotion of hematopoietic recovery in recipients, and provides significant advantages in reducing hospital stay and medical costs with a comparable safety profile. Mecapegfilgrastim thus represents a more cost-effective mobilization strategy."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Transplantation • CD34

Mecapegfilgrastim for Prophylaxis of Immunochemotherapy-Induced Neutropenia in Patients With Diffuse Large B-Cell Lymphoma: A Multicenter Pilot Trial. (PubMed, Cancer Med) - P2 | "Mecapegfilgrastim demonstrated a favorable safety profile and potential efficacy in reducing the incidence and severity of neutropenia in DLBCL patients receiving R-CHOP or R-CHOP-like regimens. These findings may support its prophylactic use in this population and warrant validation in larger trials."

Clinical • Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

Analysis of Efficacy and Risk Factors for Primary Prevention of Neutropenia in Cancer Patients Under Standardized Nutritional Intervention (ChiCTR) - P4 | N=100 | Recruiting | Sponsor: Anqing First People's Hospital; Anqing First People's Hospital

New P4 trial • Neutropenia • Oncology

An Open-label, Single-arm, Exploratory Clinical Study to Evaluate the Efficacy and Safety of mecapegfilgrastim in Preventing Chemotherapy-Induced Neutropenia in Patients with Breast Cancer (ChiCTR) - P2 | N=48 | Not yet recruiting | Sponsor: Beijing Cancer Hospital; Beijing Cancer Hospital

New P2 trial • Breast Cancer • Chemotherapy-Induced Neutropenia • Neutropenia • Oncology • Solid Tumor

Safety and Efficacy of Cyclophosphamide With Dual Mecapegfilgrastim and On-Demand Plerixafor for Salvage Mobilization in Patients With Initial Mobilization Failure: A Retrospective Cohort. (PubMed, J Clin Apher) - "In conclusion, CTX + PEG-rhG-CSF + on-demand PXF is a highly effective salvage mobilization strategy for patients with initial HSC mobilization failure, yielding higher CD34+ cell counts with fewer aphereses and acceptable safety. With balanced advantages in efficacy, safety, and cost-effectiveness, the CTX + PEG-rhG-CSF + on-demand PXF regimen can be a preferred salvage option for ASCT candidates with prior mobilization failure."

Journal • Retrospective data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Neutropenia • Oncology • Transplantation • CD34

Polyethylene glycol-conjugated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) primary prophylaxis significantly reduces the duration of neutropenia in non-Hodgkin's lymphoma patients treated with chemotherapy: a randomised trial (NCT05834751). (PubMed, Transl Cancer Res) - P=N/A | "To treat and prevent this condition, polyethylene glycol-conjugated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF; mecapegfilgrastim) has been developed...PEG-rhG-CSF was more effective than G-CSF in preventing neutropenia induced by chemotherapy regimens with a moderate- to-high-risk of FN in patients with lymphoma and contributes to better chemotherapy efficacy. ClinicalTrials.gov NCT05834751."

Journal • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

Mecapegfilgrastim for prophylaxis of immunochemotherapy-induced neutropenia in patients with diffuse large B-cell lymphoma: A multicenter pilot trial (ASH 2025) - P2 | "Conclusion : This study is the first to demonstrate that the long-acting G-CSF, mecapegfilgrastim, exhibits a favorable safety profile and effectively reduced the incidence and severity of CIN in DLBCL patients receiving R-CHOP or R-CHOP-like regimens. These findings support its potential as a prophylactic option in this population, warranting further investigation in large-scale randomized trials."

Clinical • B Cell Lymphoma • Chemotherapy-Induced Neutropenia • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma

Efficacy and safety of mecapegfilgrastim for prophylaxis of dalpiciclib-induced neutropenia in patients with advanced HR+/HER2- breast cancer: A multicenter, open-label, randomized controlled phase II trial (ESMO Asia 2025) - P2 | "Mecapegfilgrastim reduced the incidence of grade ≥3 dalpiciclib- induced neutropenia in the first cycle, thereby decreasing the rates of dalpiciclib interruption, dose reduction and discontinuation."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Mecapegfilgrastim for Preventing Chemotherapy-Induced Neutropenia in Patients with Diffuse Large B-Cell Lymphoma: A Multicenter, Open-Label, Randomized Controlled Trial (ASH 2024) - P2 | "Both groups received 4 cycles of standard R-CHOP or R-CHOP-like regimens. The incidence of serious TEAEs was 7.1% in both groups, and one patient in the study group died due to interstitial lung disease, all of which were deemed unrelated to mecapegfilgrastim.Conclusions : Mecapegfilgrastim demonstrated a good safety profile and a nonsignificant trend towards reduced incidence of grade 3/4 chemotherapy-induced neutropenia in DLBCL patients, underscoring its potential as a prophylactic option. Further study is warranted to validate these findings."

Clinical • B Cell Lymphoma • Chemotherapy-Induced Neutropenia • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Interstitial Lung Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of Single-Dose Versus Split-Dose Mecapegfilgrastim with Etoposide for Autologous Peripheral Blood Stem Cell Mobilization: A Prospective, Randomized Clinical Trial (ASH 2024) - "Baseline characteristics, including age, sex, Eastern Cooperative Oncology Group (ECOG) status, underlying disease, previous chemotherapy cycles, and prior exposure to lenalidomide, bendamustine, and radiotherapy, were comparable between the two groups. The split-dose regimen demonstrated a superior optimal mobilization rate at the first collection, suggesting that it may offer a more efficient mobilization approach. The combination of mecapegfilgrastim and high-dose etoposide represents a promising strategy for PBSC mobilization, which merits further investigation."

Clinical • Anemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia • CD34

ANC-IIT-004: Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Affiliated Hospital of Nantong University

New P2 trial • Oncology • Thoracic Cancer

A Trial of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of Chemotherapy-related Moderate to Severe Neutropenia of Patients With Nonmyeloid Malignancies (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=107 ➔ 0 | Trial completion date: Jun 2024 ➔ Jul 2025 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: May 2024 ➔ Jul 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Febrile Neutropenia • Neutropenia • Oncology

MECAPEGFILGRASTIM FOR PROPHYLAXIS OF CHEMOTHERAPY-INDUCED NEUTROPENIA IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA: A MULTICENTER PILOT TRIAL (ICML 2025) - P2 | "Both groups received 4 cycles of R-CHOP or R-CHOP-like chemotherapy. Mecapegfilgrastim demonstrated a favorable safety profile and effectively reduced the incidence and severity of CIN in DLBCL patients. These findings support its potential as a prophylactic option in this population, warranting further investigation in large-scale randomized trials."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Jan 2025

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2