Efbemalenograstim alfa for the primary/secondary prophylaxis of intermediate-risk febrile neutropenia (FN) chemotherapy regimen with risk factors in patients with non-small cell lung cancer (NSCLC): A randomized, multicenter, exploratory clinical trial.

Abstract

e20560 Background: Neutropenia is a very common dose-limiting toxicity of chemotherapy. The extent and duration of neutropenia can variably affect the clinical efficacy of chemotherapy. While high-risk FN chemotherapy regimens are relatively rare in non-small cell lung cancer(NSCLC), the proportion of patients with risk factors receiving G-CSF prophylaxis for intermediate-risk FN regimens is low in the real world. This study will observe the efficacy and safety of efbemalenograstim alfa in preventing absolute neutrophil count(ANC) reduction following chemotherapy in NSCLC patients with intermediate-risk FN chemotherapy regimen with risk factors. Methods: This is a randomized, multicenter, exploratory clinical study (NCT06143735) enrolled patients with NSCLC at moderate risk undergoing chemotherapy regimens with associated risk factors. Eligible patients were randomly assigned to receive either primary or secondary prophylaxis. The primary prophylaxis group began administration of efbemalenograstim alfa, 20mg, via subcutaneous injection starting after the first round of chemotherapy, administered 48±4 hours after the completion of each chemotherapy cycle. The control group would receive efbemalenograstim alfa 48±4 hours after the completion of the next chemotherapy cycle, if ≥ Grade 3 ANC reduction occurred in the previous cycle. Subjects received at least four cycles of platinum-based chemotherapy. The primary objective of the study was to evaluate the incidence rate of Grade ≥3 ANC reduction during the first chemotherapy cycle in two groups of participants receiving primary and secondary prophylaxis with efbemalenograstim alfa. Secondary objectives included evaluating the incidence rate of FN, the incidence rate of Grade ≥3 ANC reduction during others chemotherapy cycles and adverse events/serious adverse events. Results: As of January 1, 2025. 39 patients (median age 66 years, with 69% having ECOG performance status of 0 or 1, 87% being male) had been enrolled and received treatment. 26 patients were assigned to the primary prophylaxis group and 13 patients were in the control group. 3 (11.5%) and 9 (69.2%) patients experienced Grade ≥3 reduction in ANC during the first cycle of chemotherapy. 1 (3.8%) and 2 (15.4%) patients experienced FN. Ten patients (27.8%) experienced treatment-related adverse events of efbemalenograstim alfa, three patients experienced arthralgia (7.7%). 16 patients (41.0%) experienced Grade≥3 adverse events. The most common Grade ≥3 adverse events were related to chemotherapy. Conclusions: Efbemalenograstim alfa demonstrated promising clinical efficacy in the prophylactic management of chemotherapy-induced neutropenia, reducing the risk of infection and enhancing patients' quality of life. Clinical trial information: NCT06143735 .