Neurapeg (pegteograstim) / Green Cross Cell - LARVOL DELTA

Pegylated granulocyte colony-stimulating factor primary prophylaxis versus no prophylaxis in patients with unresectable pancreatic cancer treated with modified-FOLFIRINOX: a randomized, open-label, multicenter, phase 2 trial. (PubMed, EClinicalMedicine) - P2 | "Patients received oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, irinotecan 150 mg/m2, and fluorouracil 2400 mg/m2 via continuous infusion, every other week. After 1:1 randomization, peg-GCSF (pegteograstim 6 mg, GC Biopharma Corp.) was subcutaneously administered on day 4 for the initial eight cycles for the primary prophylaxis group, whereas no G-CSF was given to the control group...This study provides a rationale for peg-GCSF primary prophylaxis in patients with pancreatic cancer treated with mFOLFIRINOX. GC Biopharma Corp.; Severance Hospital Research Fund for Clinical Excellence; National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT)."

Journal • P2 data • Febrile Neutropenia • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Pancreatic Cancer • Solid Tumor

A Multicenter Phase II Study of Modified FOLFIRINOX for First-line Treatment for Advanced Urachal Cancer (ULTMA; KCSG GU20-03). (PubMed, Cancer Res Treat) - P2 | "The ULTIMA trial (NCT04611724) is a single-arm, open-label, multicenter phase II study evaluating modified FOLFIRINOX (Oxaliplatin 85 mg/m2 over 2 hours, Irinotecan 150 mg/m2 over 1.5 hours, Leucovorin 400 mg/m2 over 2 hours, and 5-FU 2400 mg/m2 over 46 hours) plus prophylactic pegteograstim in patients with recurrent or metastatic urachal cancer every 2 weeks for up to 12 cycles, or until disease progression or unacceptable toxicity...In this preliminary analysis of ULTIMA trial, Modified FOLFIRINOX demonstrated a promising ORR and PFS in patients with advanced urachal cancer. Completing the full study is essential to confirm the potential role of this regimen in the management of advanced urachal cancer."

Journal • P2 data • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Phase II Trial of Neoadjuvant Docetaxel/Cisplatin/5-Fluorouracil Combined with Pegteograstim for Unresectable, Locally Advanced Sinonasal Squamous Cell Carcinoma: KCSG HN18-07. (PubMed, Cancer Res Treat) - "Treatment-related adverse events of grade ≥3 were neutropenia (48.1%) including febrile neutropenia (14.8%), followed by acute kidney injury (22.2%), nausea/vomiting (11.1%), anemia (7.4%), thrombocytopenia (7.4%), and enterocolitis (3.7%). TPF NAC showed a promising efficacy and might help preserve critical structures in this population, which needs to be validated in a large prospective trial (KCT0003377)."

Journal • Metastases • P2 data • Acute Kidney Injury • Febrile Neutropenia • Gastrointestinal Disorder • Hematological Disorders • Nephrology • Neutropenia • Oncology • Otorhinolaryngology • Renal Disease • Squamous Cell Carcinoma • Thrombocytopenia

REAL-WORLD REVIEW OF THROMBOCYTOPENIA ASSOCIATED WITH LONG ACTING GRANUL OCYTE COLONY-STIMULATING FACTOR IN EPITHELI AL OVA RIAN CANCER PATIENTS (ECOP 2024) - "Material and m ethod This retrosp ective stud y inclu ded 62 patients aged 18 years or older with a diagno sis of EOC wh o received pegfilgrastim, pegteograstim, an d efla pegrastim between January 2021 and Dece mber 2023 at a tertiary hospital in South Korea. Conclusion In this real-wo rld based retrospective study, it showed mo re than a quarter of EOC patien ts receiving long-actin g G- CSF experien ced thromb ocytopenia. However, the study also ind icates that while the use of long-acting G-CSF in chemotherapy p atients may lead to thrombocytopen ia, it has minimal impact on treatment schedules and dose intensity."

Real-world • Real-world evidence • Review • Genetic Disorders • Hematological Disorders • Obesity • Oncology • Solid Tumor • Thrombocytopenia

Comparison of prophylactic effects for chemotherapy induced neutropenia between SamE-day vs next-day administration of pegteograstim in chemotherapy regimen composed of day 1 intensive myleosuppressive agent: A randomized phase III trial (CONCISE, KCSG PC22-11) (KSMO 2024) - No abstract available

Clinical • P3 data • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia

Primary prophylaxis with pegylated-granulocyte colony-stimulating factor for patients with unresectable pancreatic cancer treated with modified-FOLFIRINOX: A randomized phase II trial. (ASCO 2024) - "Patients received oxaliplatin 85mg/m 2 D1 + leucovorin 400mg/m 2 D1 + irinotecan 150mg/m 2 D1 + 5-FU 2,400mg/m2 46h continuous infusion, every other week. After 1:1 randomization, peg-GCSF (pegteograstim 6 mg, GC Biopharma Corp.) was administered on day 4 for initial 8 cycles for primary prophylaxis group, where no G-CSF was given for control group... Primary prophylaxis with peg-GCSF significantly reduced grade 3-4 neutropenia and febrile neutropenia in patients with locally advanced or metastatic pancreatic cancer treated with mFOLFIRINOX events. Considering the study design of permitting the crossover, cumulative RDI was similar. Further follow-up of survival and quality of life results will be presented."

P2 data • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Pancreatic Cancer • Solid Tumor

A phase II trial of neoadjuvant docetaxel/5-FU/cisplatin in combination with prophylactic pegteograstim in unresectable, locally advanced nasal cavity/paranasal squamous cell carcinoma: KCSG HN18-07. (ASCO 2024) - "DFP NAC demonstrated promising efficacy and an excellent eyeball preservation rate with manageable toxicity. DFP NAC with prophylactic pegteograstim, could be a reasonable option for patients with locally advanced SCC of the PNSNC. Follow-up is ongoing."

Clinical • Combination therapy • Metastases • P2 data • Febrile Neutropenia • Neutropenia • Oncology • Otorhinolaryngology • Squamous Cell Carcinoma

Comparison of prophylactic effects for chemotherapy-induced neutropenia between same-day vs next-day administration of pegteograstim in chemotherapy regimen composed of day 1 intensive myelosuppressive agent: A randomized phase III trial (CONCISE, KCSG PC22-11). (ASCO 2024) - "Background: Administration of peg-GCSF 24 to 72 hours after chemotherapy is usually recommended...Patients with adjuvant/neoadjuvant or 1st palliative chemotherapy comprising intensively myleosuppressive agents on day 1 (mFOLFIRINOX, ECb, EP, FOLFIRI, and FOLFOX) are enrolled...This results in the need for a total of 160 patients, 80 in each arm. We are currently recruiting patients (since Nov 2022)."

Clinical • P3 data • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia

A multicenter phase II study of modified FOLFIRINOX for first-line treatment for advanced urachal cancer (ULTMA; KCSG GU20-03). (ASCO 2024) - P2 | " Patients with recurrent or metastatic urachal cancer with measurable lesions received modified FOLFIRINOX (Oxaliplatin 85 mg/m 2 over 2 hours, Irinotecan 150 mg/m 2 over 1.5 hours, Leucovorin 400 mg/m 2 over 2 hours and 5-FU 2400 mg/m 2 over 46 hours) with prophylactic pegteograstim 6 mg SC on day 3 Q2W till 12 cycles (or until progression or unacceptable toxicities)... The first prospective ULTIMA study showed encouraging ORR and PFS in patients with advanced urachal cancer. The regimen is well tolerated without febrile neutropenia with prophylactic pegteograstim. Further analysis of efficacy will be presented."

Clinical • Metastases • P2 data • Anemia • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX (clinicaltrials.gov) - P2 | N=78 | Active, not recruiting | Sponsor: Yonsei University

Metastases • New P2 trial • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

Comparison of prophylactic effects for chemotherapy induced neutropenia between same-day versus next-day administration of pegteograstim (Neurapeg®) in patients treated with chemotherapy regimen composed of day 1 intensive myleosuppressive agent: A randomized phase III clinical trial. (PubMed, Medicine (Baltimore)) - "Administration of pegylated granulocyte-colony-stimulating factor (peg-GCSF) 24 to 72 hours after chemotherapy is usually recommended...Patients with adjuvant/neoadjuvant or first-line palliative chemotherapy comprising intensively myelosuppressive agents on day 1 (mFOLFIRINOX, ECb, EP, FOLFIRI, and FOLFOX) are enrolled...In order to verify non-inferiority of 0.6 days, we estimated a significance level of 5%, power of 80%, and drop-out rate of 15%. This results in the need for a total of 160 patients, 80 in each group."

Journal • P3 data • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia

Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=19 | Completed | Sponsor: Seoul National University Hospital | Recruiting ➔ Completed | N=32 ➔ 19 | Trial completion date: Jun 2025 ➔ Dec 2022

Enrollment change • Trial completion • Trial completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors. (PubMed, J Pediatr Hematol Oncol) - P2 | "Pegteograstim is safe and shows comparable efficacy to conventional filgrastim in children and adolescents. Randomized controlled trials are needed to confirm its safety and efficacy."

Clinical • Journal • Dermatology • Hematological Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Respiratory Diseases • Solid Tumor • Urticaria

Pegteograstim prophylaxis for chemotherapy-induced neutropenia and febrile neutropenia: a prospective, observational, postmarketing surveillance study in Korea. (PubMed, Support Care Cancer) - "The prophylactic use of pegteograstim might have good overall safety and efficacy in patients with lymphomas and solid malignancies in routine clinical practice, even in those who are elderly and have liver and renal diseases."

Clinical • Journal • Observational data • P4 data • Breast Cancer • Hematological Disorders • Hematological Malignancies • Hypotension • Infectious Disease • Lymphoma • Nephrology • Neutropenia • Oncology • Pneumonia • Renal Disease • Respiratory Diseases • Solid Tumor

[VIRTUAL] Supportive function of pegteograstim and pegfilgrastim on chemotherapy-induced neutropenia in ovary cancer patients (ESGO 2020) - "We undertook investigation to evaluate efficacy and safety of pegteograstim and pegfilgrastim women with ovarian carcinoma that are treated with paclitaxel/carboplatin...Safety profiles of two groups did not differ significantly. Conclusion We conclude Pegteograstim and pegfilgrastim have similar efficacy and safety profile in the reduction of chemotherapy-induced neutropenia in the ovary cancer patients who were undergoing chemotherapy"

Clinical • Hematological Disorders • Neutropenia • Oncology • Ovarian Cancer