HHPG-19K (mecapegfilgrastim) / Jiangsu Hengrui Pharma - LARVOL DELTA

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

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

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

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

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

MA-ASCT-II-002: Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Trial completion date: Sep 2024 ➔ Sep 2026 | Trial primary completion date: Mar 2024 ➔ Mar 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Multiple Myeloma • Neutropenia • Oncology

Mecapegfilgrastim prophylaxis for neutropenia in patients with non-myeloid malignancies: A Chinese nationwide real-world study. (PubMed, BMC Cancer) - "This RWS reinforces the safety and effectiveness of mecapegfilgrastim in preventing moderate to severe CIN among the patients with non-myeloid malignancies, with primary prophylaxis showing a lower incidence of neutropenia."

Journal • Real-world evidence • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Neutropenia • Oncology

Impact of the national health insurance coverage policy on mecapegfilgrastim utilization for chemoradiotherapy-induced neutropenia in cancer patients in China: a retrospective real-world analysis. (PubMed, Front Pharmacol) - "The NHIC policy significantly increased mecapegfilgrastim utilization, enabling more cancer patients to access this medication and effectively benefiting them. To address persistent inequities, the government should consider introducing additional measures, such as increasing the insurance reimbursement cap and separating the cost of expensive innovative anticancer medicines from hospital medical insurance budgets."

Journal • Real-world evidence • Reimbursement • Retrospective data • US reimbursement • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology

Safety and efficacy of mecapegfilgrastim in preventing neutropenia in patients with head and neck cancer: a multicenter, prospective, observational, real-world study. (PubMed, Transl Cancer Res) - "Mecapegfilgrastim was well tolerated, with no new safety signals identified. These real-world findings support its continued use for neutropenia prevention in patients with head and neck cancer."

Journal • Observational data • Real-world evidence • Febrile Neutropenia • Head and Neck Cancer • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Solid Tumor

Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

New P2 trial

Efficacy and Safety of Single-Dose Versus Split-Dose Mecapegfilgrastim with Etoposide for Autologous Peripheral Blood Stem Cell Mobilization: A Prospective, Randomized Clinical Trial [Google translation] (Jiangsu Hengrui Press Release) - P2 | N=120 | NCT05294055 | "The results showed that the median time of the first collection in both groups was D8 (range: 8-10). Compared with the single-dose group, the fractionated group showed a higher success rate of first-time high-quality mobilization (CD34+≥5×10 6 /kg) at the first collection (56.7% vs 25.9%, P=0.019), but there was no difference in the first mobilization success rate between the two groups (70.0% vs 66.7%, P=0.787). After the second collection, the success rates of high-quality mobilization in the fractionated group and the single-dose group were 70.0% and 59.3%, respectively (P=0.396), and the mobilization success rates were 76.7% and 77.8%, respectively (P=0.920)."

P2 data • Lymphoma • Multiple Myeloma

Mecapegfilgrastim for prophylaxis of febrile neutropenia in children and adolescents with rhabdomyosarcoma or Ewing sarcoma: a prospective, single-arm, pilot study. (PubMed, BMC Cancer) - "Mecapegfilgrastim showed acceptable efficacy and safety profile in pediatric and adolescent patients with RMS or ES. Further randomized studies with large sample size are warranted."

Clinical • Journal • Ewing Sarcoma • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Mecapegfilgrastim for the prophylaxis of chemotherapy-induced neutropenia in locally advanced nasopharyngeal carcinoma: A prospective phase II clinical study. (PubMed, Head Neck) - "Mecapegfilgrastim effectively reduced the incidence of chemotherapy-induced neutropenia and FN in patients with locally advanced nasopharyngeal carcinoma."

Journal • Metastases • P2 data • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Nasopharyngeal Carcinoma • Neutropenia • Oncology • Solid Tumor

A multicenter, prospective, non-interventional real-world study to assess the effectiveness of mecapegfilgrastim in preventing neutropenia in patients with gastrointestinal cancer. (PubMed, Immun Inflamm Dis) - "In a real-world setting, mecapegfilgrastim has proven effective in preventing severe neutropenia in gastrointestinal patients following chemotherapy. This includes commonly used moderate or high-risk FN regimens or regimens containing S1/capecitabine, all of which have demonstrated favorable efficacy and safety profiles."

Journal • Observational data • Real-world • Real-world evidence • Febrile Neutropenia • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

COMBINATION OF CHEMOTHERAPY AND MECAPEGFILGRASTIM FOR HEMATOPOIETIC STEM CELL MOBILIZATION IN LYMPHOMA AND MULTIPLE MYELOMA PATIENTS: A PROSPECTIVE, OPEN-LABEL, RANDOMIZED STUDY (EHA 2024) - P2 | "0 g/m2/day for 2 days) for MM or etoposide (1. The combination of chemotherapy with mecapegfilgrastim provides a rapid and convenient mobilizationstrategy in both lymphoma and MM patients. Comparatively, a trend towards increased mobilization wasobserved in the D5 group, providing the important insights in the clinical decision-making setting. The trial wasregistered at www."

Clinical • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Oncology • Respiratory Diseases • Thrombocytopenia • CD34

EFFICACY AND SAFETY OF MECAPEGFILGRASTIM IN PREVENTING CHEMOTHERAPY-INDUCED NEUTROPENIA IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (EHA 2024) - "Both groups received4 cycles of standard R-CHOP or R-CHOP-like regimens. Mecapegfilgrastim demonstrated a good safety profile and a nonsignificant trend towards reduced grade 3/4chemotherapy-induced neutropenia in DLBCL patients, underscoring its potential as a prophylactic option. Further study is warranted to validate these findings."

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

White blood cell kinetics in patients with gynecologic cancer receiving mecapegfilgrastim prophylaxis: A multicenter real-world study. (ASCO 2024) - "In patients with low body weight (≤50 kg), the administration of 6 mg mecapegfilgrastim effectively stabilizes WBC elevation, exhibiting a favorable safety and efficacy profile. This regimen ensures the timely and appropriate progression of patients to subsequent cycles of chemotherapy. WBC counts in patients."

Clinical • Real-world • Real-world evidence • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Febrile Neutropenia • Gynecologic Cancers • Hematological Disorders • Neutropenia • Oncology • Ovarian Cancer