GC Green Cross Proves Primary Prophylactic Effect of Neulapeg Against Neutropenia in Pancreatic Cancer mFOLFIRINOX Regimen

Severe Neutropenia: 2.6% vs. 38.5%
Febrile Neutropenia: 0%

GC Green Cross announced on December 16 that the results of an investigator-initiated, multi-center clinical trial of Neulapeg, a treatment for neutropenia, in pancreatic cancer patients have been published in the international journal eClinicalMedicine. Neutropenia refers to an abnormally low count of neutrophils (a type of white blood cell) in the blood. This condition significantly increases the risk of infection and is a major cause of treatment interruption or complications in cancer patients.

Neulapeg is a long-acting G-CSF2 (Granulocyte-Colony Stimulating Factor) agent. It is a second-generation neutropenia treatment developed in-house by GC Green Cross. This medication is used to prevent severe neutropenia and infectious complications that may occur after chemotherapy.

GC Green Cross Headquarters, Yongin-si, Gyeonggi-do. GC Green Cross

This study was led by Professors Lee Choongkeun and Choi Hyejin’s research team at Yonsei Cancer Center. Seventy-seven patients with unresectable locally advanced or metastatic pancreatic cancer were randomly assigned to either the Neulapeg group (38 patients) or the control group (39 patients). The researchers evaluated the efficacy and safety of primary prophylactic Neulapeg in patients undergoing mFOLFIRINOX chemotherapy. mFOLFIRINOX refers to a first-line chemotherapy regimen combining oxaliplatin, irinotecan, leucovorin, and 5-fluorouracil.

The results showed that the incidence of severe neutropenia during the first eight cycles of chemotherapy-the primary endpoint-was only 2.6% (1 patient) in the Neulapeg group, a significant reduction compared to 38.5% (15 patients) in the control group (P=0.0001). Notably, there were no cases of febrile neutropenia, which carries a high risk of infection, in the Neulapeg group, while it occurred in 12.8% (5 patients) of the control group.

Additionally, the proportion of patients who experienced a chemotherapy delay of four days or more was lower in the Neulapeg group compared to the control group, and the number of hospitalization days was also reduced. Severe neutropenia can lead to dose reductions or delays in chemotherapy schedules, which may negatively impact patient outcomes.

Furthermore, primary prophylactic administration of Neulapeg had a positive effect on patients' quality of life. The Neulapeg group showed significant improvement in patient-reported overall health status and quality of life scores (P=0.0264). The incidence of bone pain, a major side effect of G-CSF agents, did not differ between the two groups, indicating a favorable safety profile.

Professor Lee Choongkeun, the principal investigator and medical oncologist at Yonsei Cancer Center, stated, "Although the mFOLFIRINOX regimen for pancreatic cancer carries a high risk of severe neutropenia, there has been no prospective, randomized evidence supporting primary prophylactic use of G-CSF. This study is significant as it is the first prospective clinical trial to demonstrate that primary prophylactic administration of Neulapeg in pancreatic cancer patients receiving mFOLFIRINOX not only markedly reduces severe neutropenia and febrile neutropenia, but also improves quality of life and shows a trend toward prolonged survival."

Jung Jaeuk, Head of R&D at GC Green Cross, commented, "This study has confirmed that Neulapeg can provide substantial support during the treatment process for pancreatic cancer patients. We will continue research aimed at improving treatment continuity and quality of life for patients."

Meanwhile, major international guidelines, including those from the National Comprehensive Cancer Network (NCCN), recommend primary prophylactic administration of G-CSF to prevent neutropenia in patients undergoing mFOLFIRINOX for pancreatic cancer.