WCLC 2025 - Posters & ePosters-P3.18.86 Efbemalenograstim Alpha Prophylaxis for Intermediate-Risk FN Chemotherapy in NSCLC: A Multicenter Exploratory Study

P3.18.86 Efbemalenograstim Alpha Prophylaxis for Intermediate-Risk FN Chemotherapy in NSCLC: A Multicenter Exploratory Study

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This multicenter exploratory phase 2 study (NCT06143735) evaluated efbemalenograstim alpha, a novel long-acting granulocyte colony-stimulating factor (G-CSF), for prophylaxis against chemotherapy-induced neutropenia in patients with stage IIIB-IV, driver gene-negative non-small cell lung cancer (NSCLC) undergoing intermediate-risk febrile neutropenia (FN) chemotherapy regimens. Fifty-three patients were enrolled and divided into two groups: Group A (n=35) received primary prophylaxis with efbemalenograstim alpha, while Group B (n=18) received secondary prophylaxis after developing grade 3 neutropenia in a previous cycle. Patients received 20 mg subcutaneous injections on day 3 post-chemotherapy every three weeks.<br /><br />The primary endpoint was the incidence of grade 3 neutropenia during the first chemotherapy cycle. Results showed a significantly lower incidence in Group A (23.08%) compared to Group B (64.71%), indicating effective protection by primary prophylaxis (p=0.0071). Febrile neutropenia occurred in 1 patient in Group A and 2 in Group B. Secondary endpoints included incidences of FN in subsequent cycles, safety profile, and adverse events (AEs). Among 39 patients with complete AE records, all reported at least one AE, with 59% experiencing grade 3 AEs mainly related to chemotherapy; none experienced grade 3 treatment-related AEs. Pain-related AEs occurred in 10.3% of patients with symptoms such as neuropathic pain and general soreness.<br /><br />In conclusion, efbemalenograstim alpha was effective and safe for primary prophylaxis of neutropenia in NSCLC patients receiving intermediate-risk FN chemotherapy. It notably reduced grade 3 neutropenia incidence, lowering infection risk and improving patient quality of life. However, careful monitoring for AEs is warranted during its clinical use.

Asset Subtitle

Mengjie Li

Meta Tag

Speaker Mengjie Li

Topic Clinical Trials in Progress

Keywords

efbemalenograstim alpha

granulocyte colony-stimulating factor

G-CSF

chemotherapy-induced neutropenia

non-small cell lung cancer

NSCLC

febrile neutropenia

primary prophylaxis

phase 2 study

adverse events