Research ArticleOriginal Article
Open Access

Efbemalenograstim alfa as prophylaxis for chemotherapy-induced neutropenia in patients with non–small-cell lung cancer: a randomized, multicenter, phase II trial

Mengjie Li, Caixia Liu, Fengming Ran, Haitao Lan, Jun Ge, Zheng Zhao, Chuangzhou Rao, Wei Zheng, Xiaoyong Tang, Tianhui Gao, Yong Mao, Wei Cui, Zhengguo Li and Dingzhi Huang
Cancer Biology & Medicine September 2026, 20260311; DOI: https://doi.org/10.20892/j.issn.2095-3941.2026.0311

Abstract

Objective: Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) is recommended for patients receiving chemotherapy with a high risk of febrile neutropenia (FN), but its use remains suboptimal in patients receiving intermediate-risk regimens who have additional risk factors, for whom secondary prophylaxis (SPx) is commonly used despite limited prospective evidence comparing the two approaches. This study evaluated efbemalenograstim alfa (EFBGα), a novel Fc fusion G-CSF, as primary or secondary prophylaxis for chemotherapy-induced neutropenia (CIN) in patients with non–small-cell lung cancer (NSCLC) receiving intermediate-risk FN regimens who have additional risk factors.

Methods: This multicenter, randomized phase II trial enrolled chemotherapy-naïve patients with stage IIIB/IV NSCLC scheduled for platinum–taxane chemotherapy. Patients were randomized 2:1 to either primary prophylaxis (EFBGα 20 mg at 48 ± 4 h after each cycle) or secondary prophylaxis (given only after grade 3–4 neutropenia). The primary endpoint was the cycle 1 incidence of grade 3–4 neutropenia.

Results: A total of 102 patients were enrolled between February 2024 and December 2025, of whom 96 were included in the analysis: 63 in the primary prophylaxis group and 33 in the secondary prophylaxis group. In cycle 1, the incidence of grade 3–4 neutropenia was lower with primary prophylaxis than with secondary prophylaxis [20.6%, 95% confidence interval (CI) 11.5%–32.7% vs. 57.6%, 95% CI 39.2%–74.5%; risk difference –36.9%, 95% CI –52.4% to –16.1%; P < 0.001]. The median duration of grade 3–4 neutropenia was comparable between the groups (P = 0.144). Cycle 1 FN incidence was 1.6% in the primary and 6.1% in the secondary prophylaxis group. Treatment-related adverse events were mostly grade 1–2, with pain-related events (7.0%) being the most common.

Conclusions: EFBGα exhibited promising efficacy and tolerability for CIN prophylaxis in patients with NSCLC and additional risk factors who are receiving intermediate-risk chemotherapy (IRC). The results support its use in both primary and secondary prophylactic strategies, and earlier initiation was associated with better CIN control.

keywords

Introduction

Although targeted therapies and immunotherapy have transformed the treatment landscape for non–small-cell lung cancer (NSCLC), which accounts for approximately 85% of all lung cancer cases, platinum-based chemotherapy remains a cornerstone of systemic treatment1–4. Chemotherapy-induced neutropenia (CIN) is a common and clinically significant hematological toxicity associated with myelosuppressive chemotherapy5. Among patients receiving platinum–taxane regimens for NSCLC, grade 3–4 neutropenia incidence rates range from 37.5% to 56%, while febrile neutropenia (FN) occurs in approximately 9%–12.7% of patients6–9. Severe neutropenia and FN can increase the risk of infection and frequently result in chemotherapy dose reductions or delays, which may ultimately compromise therapeutic efficacy10,11.

Study flow
Study flow

This multicenter, open-label, randomized phase II trial across 13 centers in China evaluated primary versus secondary prophylaxis with EFBGα for CIN in patients with stage IIIB/IV NSCLC receiving platinum–taxane chemotherapy who had ≥1 risk factor for FN (age ≥65 years or ECOG PS ≥2). The study rationale and design are presented, including patient eligibility, 2:1 randomization, treatment strategies, and study endpoints. Patient disposition and baseline characteristics are summarized, with 96 evaluable patients (mITT/SAS; primary, n = 63; secondary, n = 33) included after 6 exclusions. The primary and secondary efficacy outcomes and safety results are highlighted. The incidence of grade 3–4 neutropenia in cycle 1 was 20.6% with primary prophylaxis versus 57.6% with secondary prophylaxis (risk difference −36.9%, 95% CI −52.4% to −16.1%; P < 0.001). The median neutropenia duration was comparable between the groups (2.0 vs. 3.0 days; P = 0.144). The key findings demonstrate that EFBGα provided effective and well-tolerated CIN prophylaxis, and that earlier initiation was associated with better CIN control, which support further evaluation in phase III trials. CI, confidence interval; CIN, chemotherapy-induced neutropenia; ECOG PS, Eastern Cooperative Oncology Group performance status; FN, febrile neutropenia; IWRS, Interactive Web Response System; mITT, modified intention-to-treat; NSCLC, non–small-cell lung cancer; RD, risk difference; SAS, safety analysis set; SC, subcutaneous (injection); TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.

According to current guidelines, the decision to initiate primary granulocyte colony-stimulating factor (G-CSF) prophylaxis is mainly guided by regimen-associated FN risk: prophylaxis is recommended for patients receiving high-risk chemotherapy regimens (FN risk > 20%) and should be considered for those receiving intermediate-risk regimens in the presence of additional patient-specific risk factors (e.g., advanced age, poor performance status, bone marrow involvement, or previous chemotherapy or radiotherapy)12–14. However, implementation of primary prophylaxis (PPx) in routine clinical practice remains suboptimal among patients receiving intermediate-risk chemotherapy (IRC), particularly older adults, owing to physician underestimation of individual FN risk, suboptimal guideline adherence, or access-related barriers15–17. Real-world evidence indicates that the actual risk of FN associated with IRC regimens is frequently underestimated, especially in older patients with multiple chronic comorbidities and higher FN risk15,18, which can result in delayed initiation of prophylactic G-CSF. Consequently, many patients start G-CSF therapy only after neutropenia occurs, so secondary prophylaxis (SPx) is a common real-world management strategy for patients receiving IRC15,19. Therefore, evaluations of PPx and SPx in this setting may help in clarifying the clinical consequences of earlier versus event-triggered G-CSF prophylaxis, but prospective evidence remains limited.

Efbemalenograstim alfa (EFBGα) is a novel, long-acting, dimeric G-CSF comprising a recombinant human G-CSF (rhG-CSF) fused to the Fc fragment of human IgG2 via a peptide linker, and provides more stable pharmacokinetics, sustained neutrophil stimulation, and lower immunogenicity in comparison to conventional G-CSF agents20–22. Preclinical studies have demonstrated that EFBGα accelerates neutrophil recovery and mitigates the severity of cyclophosphamide-induced neutropenia21,23. Furthermore, findings from previous phase II studies in patients with solid tumors support its role in the prevention of chemotherapy-induced myelosuppression20. Controlled clinical studies in breast cancer have demonstrated that EFBGα is noninferior to pegfilgrastim in preventing FN, with comparable safety, and may represent a more potent activator of the G-CSF receptor24. However, its role in different prophylactic strategies for patients receiving IRC has not been established. Therefore, we conducted a multicenter, open-label, randomized phase II trial to evaluate the efficacy and safety of EFBGα when used as PPx or SPx for CIN in patients with NSCLC receiving IRC regimens who had additional risk factors. This study was designed to reflect contemporary clinical decision-making regarding earlier versus event-triggered G-CSF use in this patient population.

Materials and methods

Study design and patients

This was a multicenter, randomized, controlled clinical study conducted at 13 participating centers in China (Table S1). The study was conducted in accordance with the Declaration of Helsinki and Guidelines for Good Clinical Practice. The study protocol and all amendments were reviewed and approved by the institutional review board of Tianjin Medical University Cancer Institute and Hospital (approval no. E20231250), as well as the ethics review boards of all participating centers. Written informed consent was obtained from all patients before study enrollment. The study is registered on ClinicalTrials.gov as NCT06143735.

Patients aged ≥18 years with a histopathologically or cytologically confirmed diagnosis of stage IIIB–IV, driver-negative NSCLC were eligible for enrollment. Participants were required to be chemotherapy-naïve and scheduled to receive platinum–taxane chemotherapy. Eligible patients were also required to have at least one risk factor for FN [age ≥65 years or Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2]. Additional eligibility criteria were estimated life expectancy of longer than 12 weeks, hemoglobin (Hb) ≥90 g/L, an absolute neutrophil count (ANC) ≥2.0 × 109/L, and a platelet count >80 × 109/L. Biochemical parameters had to meet the following criteria: total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 ULN; and serum creatinine ≤1.5 ULN or an endogenous creatinine clearance rate of ≥50 mL/min.

Major exclusion criteria consisted of prior systemic chemotherapy or radiotherapy, prior bone marrow or stem cell transplant, or comorbid malignancies other than NSCLC. Patients with active central-nervous-system metastases or carcinomatous meningitis were excluded, except those with asymptomatic, clinically stable brain metastases. Patients were excluded if they had a history of acute congestive heart failure, cardiomyopathy, or myocardial infarction, prior grade ≥3 neutropenia lasting ≥3 days or FN, or bone marrow involvement by tumor. Detailed inclusion and exclusion criteria are provided in the Supplementary material.

Randomization and masking

Eligible patients were randomly assigned in a 2:1 ratio to receive EFBGα as either PPx or SPx. The 2:1 allocation ratio was selected for ethical considerations, allowing more patients to receive PPx while preserving adequate statistical power, given prior evidence suggesting that PPx with G-CSF may reduce CIN more effectively than SPx25. The randomization sequence was generated by an independent statistician and was implemented through a centralized interactive web response system (IWRS). Patients were randomized using stratified block randomization (block size: 3), with competitive enrollment across participating centers. Randomization was stratified by the platinum-based chemotherapy regimen (carboplatin vs. cisplatin). After investigators confirmed eligibility and registered participants in the IWRS, treatment assignments were automatically generated according to the prespecified randomization schedule to ensure allocation concealment throughout enrollment. As this was an open-label study, patients and investigators were not masked to treatment assignment, but personnel responsible for data management and statisticians were blinded to treatment assignment until database lock.

Procedure

All participants were scheduled to receive at least four cycles of platinum–taxane chemotherapy comprising carboplatin or cisplatin combined with paclitaxel, nab-paclitaxel, paclitaxel liposomes, or paclitaxel polymer micelles (Table S2), with or without immunotherapy or antiangiogenic therapy. In the PPx group, EFBGα was administered as a 20-mg subcutaneous injection 48 ± 4 h after completion of chemotherapy in each cycle (Figure S1). In the SPx group, EFBGα (20 mg subcutaneously) was administered starting in the next chemotherapy cycle if the patient developed grade 3–4 neutropenia following the prior cycle. Treatment continued until withdrawal of consent, unacceptable toxicity, or investigator-determined clinical ineligibility for further study participation.

All patients received the recommended chemotherapy dose in the first cycle. If a patient experienced a second episode of grade 3–4 neutropenia, or if the investigator determined that the patient was at risk of infection or other potentially life-threatening complications, chemotherapy dose modification was permitted. Patients who required a delay of chemotherapy because of adverse events (AEs) were allowed a recovery period of up to 14 days. Patients who failed to meet these criteria (Hb ≥90 g/L, ANC ≥2.0 × 109/L, and platelet count ≥80 × 109/L) during the recovery period were excluded from the study.

Assessment

Laboratory tests, physical examinations, measurement of vital signs, electrocardiograms, and ultrasound assessments were performed at baseline, before each chemotherapy cycle, and 21 days after administration of the final chemotherapy dose. Complete blood counts were obtained on days 1, 5–6, 8–9, 12–13, and 15–16 of each chemotherapy cycle. An on-site visit was conducted 21 days after the final dose, followed by a safety follow-up assessment by telephone 30 days after the last dose. Safety was evaluated via monitoring and grading of AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.

Endpoints

The primary endpoint was the incidence of grade 3–4 neutropenia (defined as ANC < 1.0 × 109/L) during the first chemotherapy cycle. Secondary endpoints included FN incidence across all cycles and grade 3–4 neutropenia incidence from cycle 2 onwards, as well as safety. FN was defined as ANC < 1.0 × 109/L accompanied by either a single oral temperature of >38.3°C (101°F) or a temperature of ≥38.0°C (100.4°F) sustained for >1 h.

Statistical analysis

The sample size was determined on the basis of phase III data for mecapegfilgrastim in patients with advanced NSCLC receiving first-line docetaxel plus platinum chemotherapy (cycle 1 grade ≥3 neutropenia: 14.6% in the mecapegfilgrastim group vs. 50.0% in the control group)25. Considering the intermediate risk of FN associated with the chemotherapy regimen used in the present study, it was assumed that the incidence of grade 3–4 neutropenia would be 5% in the PPx group and 30% in the SPx group. With a two-sided α of 0.05, 80% power, and a planned allocation ratio of 2:1, a total of 99 patients (66 in the experimental group and 33 in the control group) were required after accounting for an anticipated dropout rate of 20%.

Efficacy endpoints in cycle 1 were analyzed in the modified intention-to-treat population, which included all randomized patients who received at least one dose of study drug and had at least one postbaseline efficacy assessment. For cycle-specific assessments beyond cycle 1, analyses were performed in the subgroup of patients who completed the corresponding chemotherapy cycle and had an evaluable assessment. Safety outcomes were assessed in the safety analysis set, which included all patients who received at least one dose of the study drug and had at least one postbaseline safety assessment.

Baseline characteristics and safety outcomes were summarized descriptively, with continuous variables reported as the mean ± standard deviation or median (range), and categorical variables reported as counts and percentages. For each chemotherapy cycle, patients without an ANC assessment during that cycle were excluded from the incidence analysis for that cycle, whereas those with at least one ANC assessment were included. Two-sided 95% confidence intervals (CIs) for incidence proportions were estimated using the Clopper–Pearson exact method. Between-group comparisons of the prespecified primary endpoint (grade 3–4 neutropenia during cycle 1) were conducted using the Cochran–Mantel–Haenszel test, and differences in event rates with corresponding 95% CIs were estimated using the Miettinen–Nurminen method. Secondary efficacy endpoints, including FN incidence across all cycles and grade 3–4 neutropenia incidence from cycle 2 onwards, were analyzed descriptively; no formal hierarchical hypothesis testing or multiplicity adjustment was performed. Exploratory subgroup analyses of the primary endpoint were performed descriptively according to key baseline characteristics, including age, ECOG PS, histological subtype, chemotherapy regimen, and concomitant immunotherapy use. Statistical analyses were performed using SAS version 9.4. All tests were two-sided, and P ≤ 0.05 was considered statistically significant.

Results

Study patients

Between February 2024 and December 2025, 109 patients were assessed for eligibility, of whom 102 were enrolled and randomized to either the PPx group (n = 68) or the SPx group (n = 34; Figure 1). In the PPx group, three patients withdrew consent after randomization and two discontinued shortly after treatment initiation without evaluable efficacy data. In the SPx group, one patient died after randomization before receiving the study treatment. The safety and primary efficacy population therefore comprised 63 patients in the PPx group and 33 in the SPx group.

Consolidated Standards of Reporting Trials (CONSORT) diagram of patient flow in the study. A total of 109 patients were assessed for eligibility, of whom 102 were assigned in a 2:1 ratio to either primary prophylaxis (n = 68) or secondary prophylaxis (n = 34). Five patients in the primary prophylaxis group (3 withdrew consent and 2 had no post-baseline efficacy assessment) and one in the secondary prophylaxis group (died after randomization before receiving study treatment) were excluded from the modified intention-to-treat and safety analysis sets.
Figure 1

Consolidated Standards of Reporting Trials (CONSORT) diagram of patient flow in the study. A total of 109 patients were assessed for eligibility, of whom 102 were assigned in a 2:1 ratio to either primary prophylaxis (n = 68) or secondary prophylaxis (n = 34). Five patients in the primary prophylaxis group (3 withdrew consent and 2 had no post-baseline efficacy assessment) and one in the secondary prophylaxis group (died after randomization before receiving study treatment) were excluded from the modified intention-to-treat and safety analysis sets.

Baseline characteristics were well balanced between the two groups (Table 1). Across the 96 patients included, the median age was 69 years (range 48–78), with 76.0% aged ≥65 years. The majority of patients were male (90.6%), had squamous cell carcinoma (78.1%), and presented with clinical stage IV disease (56.3%). Among the patients, 40.6% had an ECOG PS of 2, and 65.6% were former or current smokers. Most patients received carboplatin plus a taxane (PPx group 77.8%; SPx group 78.8%), while the remainder received cisplatin plus a taxane. Concomitant immunotherapy or antiangiogenic therapy was reported for eight patients (12.7%) in the PPx group and nine (27.3%) in the SPx group (Table S3).

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Table 1

Baseline characteristics

Efficacy

During cycle 1, the incidence of grade 3–4 neutropenia was lower in the PPx group (20.6%, 95% CI 11.5%–32.7%) than in the SPx group (57.6%, 95% CI 39.2%–74.5%), with a risk difference of –36.9% (95% CI –52.4% to –16.1%; P < 0.001; Figure 2A). The median duration of grade 3–4 neutropenia was 2.0 days (range 1.0–4.0) in the PPx group and 3.0 days (range 1.0–9.0) in the SPx group (P = 0.144). According to the exploratory subgroup analyses, the estimated risk differences generally favored PPx over SPx across the subgroups assessed, with numerically greater reductions observed in several subgroups (Table S4). Given the limited sample sizes in several subgroups, these findings should be interpreted with caution.

Incidence of grade 3–4 neutropenia and febrile neutropenia across chemotherapy cycles. (A) Incidence of grade 3–4 neutropenia in each chemotherapy cycle and overall. (B) Incidence of febrile neutropenia in chemotherapy cycles 1 and 3 and overall. No febrile neutropenia events occurred in the other chemotherapy cycles. C, cycle.
Figure 2

Incidence of grade 3–4 neutropenia and febrile neutropenia across chemotherapy cycles. (A) Incidence of grade 3–4 neutropenia in each chemotherapy cycle and overall. (B) Incidence of febrile neutropenia in chemotherapy cycles 1 and 3 and overall. No febrile neutropenia events occurred in the other chemotherapy cycles. C, cycle.

In cycle 2, the incidence of grade 3–4 neutropenia was 9.3% (95% CI 3.1%–20.3%) in the PPx group and 35.7% (95% CI 18.6%–55.9%) in the SPx group. Among 16 patients in the SPx group who developed grade 3–4 neutropenia in cycle 1 and subsequently received EFBGα in cycle 2, only three (18.8%) experienced recurrent grade 3–4 neutropenia. In cycle 3, the corresponding incidence rates were 19.5% (95% CI 8.8%–34.9%) and 0.0% (95% CI 0.0%–13.7%). During cycles 4–6, the incidence of grade 3–4 neutropenia remained low in both groups, ranging from 0.0% to 20.6% in the PPx group, and from 10.0% to 20.0% in the SPx group. Over the entire treatment period, the cumulative incidence of grade 3–4 neutropenia was 38.1% (95% CI 26.1%–51.2%) in the PPx group and 84.8% (95% CI 68.1%–94.9%) in the SPx group.

FN was observed only in cycles 1 and 3. During cycle 1, FN occurred in one patient (1.6%, 95% CI 0.0%–8.5%) in the PPx group and two patients (6.1%, 95% CI 0.7%–20.2%) in the SPx group. During cycle 3, FN occurred in one patient (2.4%, 95% CI 0.0%–12.9%) in the PPx group, with no FN events reported in the SPx group (0.0%, 95% CI 0.0%–13.7%; Figure 2B).

Mean ANC data over time are shown in Figure 3. The ANC nadir consistently occurred around day 8 across cycles in both groups. The mean ANC at nadir was 7.6 × 109/L in the PPx group and 2.3 × 109/L in the SPx group in cycle 1, and 7.6 × 109/L and 3.1 × 109/L in cycle 2, respectively (Table S5). Overall, mean ANC levels were numerically higher in the PPx group during cycles 1 and 2, whereas ANC profiles were generally comparable between the two groups in subsequent cycles.

Absolute neutrophil count profile across chemotherapy cycles 1–4. Mean absolute neutrophil count levels were assessed at predefined time points within each chemotherapy cycle (day 1, days 5–6, days 8–9, days 12–13, and days 15–16). Data are presented as mean ± standard deviation. C, cycle; D, day.
Figure 3

Absolute neutrophil count profile across chemotherapy cycles 1–4. Mean absolute neutrophil count levels were assessed at predefined time points within each chemotherapy cycle (day 1, days 5–6, days 8–9, days 12–13, and days 15–16). Data are presented as mean ± standard deviation. C, cycle; D, day.

Safety

Chemotherapy dose modifications because of treatment-emergent AEs (TEAEs) were less frequent in the PPx group than in the SPx group (19.0% vs. 45.5%; Table S6). Dose reductions were less frequent with PPx (9.5% vs. 30.3%), primarily because of fewer hematological dose reductions (6.3% vs. 18.2%). The incidence of dose delays was similar between the groups (14.3% vs. 15.2%). Modified relative dose intensity (RDI) analysis showed a median RDI of 1.00 in both groups (Table S7). Mean RDI was 0.966 ± 0.081 in the PPx group and 0.913 ± 0.126 in the SPx group; the proportions of patients maintaining RDI ≥ 85% were 87.3% and 72.7%, respectively.

All TEAEs occurring in ≥5% of patients in either group are summarized in Table 2. TEAEs occurred in 63 patients (100.0%) in the PPx group and 32 patients (97.0%) in the SPx group. The most common TEAEs of any grade were anemia (68.3% vs. 78.8%), neutrophil count decrease (50.8% vs. 90.9%), thrombocytopenia (47.6% vs. 51.5%), and leukopenia (44.4% vs. 78.8%). Grade ≥3 TEAEs occurred in 38 patients (60.3%) in the PPx group and 30 patients (90.9%) in the SPx group, with a decrease in neutrophil count (38.1% vs. 84.8%), leukopenia (23.8% vs. 27.3%), and thrombocytopenia (7.9% vs. 21.2%) the most common. Three patients (3.1%) died during treatment; none of the deaths were considered related to EFBGα.

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Table 2

Frequency of treatment-emergent adverse events (incidence ≥5% in any treatment group)

Among the 86 patients who received EFBGα (PPx: n = 63; SPx: n = 23), treatment-related AEs (TRAEs) of any grade occurred in 26 patients (30.2%; Table 3). The most common TRAEs (>3.0%) were pain-related events (7.0%, 6/86), including pain, arthralgia, neuropathic pain, back pain, and ankle pain, followed by anemia (5.8%, 5/86) and hyperuricemia (3.5%, 3/86). The two treatment-related cases of fever were both grade 1. Grade 3 TRAEs were observed in two patients (2.3%), including leukocytosis (1.2%, 1/86) and atrial flutter (1.2%, 1/86). No grade 4 or 5 TRAEs were reported. Grade 3 atrial flutter was the only serious TRAE, which occurred in cycle 3 following EFBGα administration and led to hospitalization. It was considered treatment-related by the investigator on the basis of its temporal relationship with treatment and the known cardiac adverse reactions described in the approved prescribing information for EFBGα; this TRAE subsequently resolved. No EFBGα-related hypersensitivity reactions were reported.

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Table 3

Treatment-related adverse events in the cohort of 86 patients who received efbemalenograstim alfa (n = 63, primary prophylaxis; n = 23, secondary prophylaxis).

During cycle 1, infections occurred in two patients (3.2%) in the PPx group (both pulmonary infections) and three patients (9.1%) in the SPx group (urinary tract infection, pulmonary infection, and pharyngitis in 1 patient each). Antibiotics were administered to eight patients (12.7%) in the PPx group and five (15.2%) in the SPx group. Regarding FN-related healthcare resource utilization, all four patients who developed FN (2 in each group) required hospitalization or prolonged hospitalization, and three received intravenous antibiotics (2 in the PPx group and 1 in the SPx group).

Discussion

This study provides the first prospective evidence supporting the efficacy and safety of EFBGα for CIN prevention in patients with NSCLC undergoing myelosuppressive chemotherapy. Both PPx and SPx exhibited preventive activity and a manageable safety profile in patients with FN risk factors receiving IRC regimens, with lower rates of grade 3–4 neutropenia observed in the PPx group. Overall, our findings support the clinical utility of EFBGα as a prophylactic intervention across both primary and secondary settings in this patient population.

The lower incidence of grade 3–4 neutropenia during cycle 1 of PPx should be interpreted in the context of the study design. As SPx was initiated only after a grade 3–4 neutropenia event, the between-group difference observed reflects pre-emptive vs. event-triggered G-CSF use rather than a direct comparison of two strategies initiated concurrently before chemotherapy, which is a scenario that closely mirrors routine clinical practice for patients receiving IRC who have additional FN risk factors15,18,19. The PPx group had numerically fewer chemotherapy dose modifications and a numerically higher proportion of patients maintaining RDI ≥85%, which is consistent with the lower cycle 1 neutropenia burden. Maintaining RDI ≥85% has been associated with better survival outcomes in previous studies26, so these findings underscore the potential clinical relevance of dose intensity maintenance, although prospective evaluation of survival outcomes is still warranted. Importantly, SPx was associated with a substantial benefit after initiation. Only three of the 16 patients who developed grade 3–4 neutropenia in cycle 1 experienced recurrent events in cycle 2, and the between-group difference in mean ANC progressively diminished thereafter. Given the limited ability of current FN risk factors to predict individual-level risk27, our findings support a flexible, individualized prophylactic approach in which both primary and SPx with EFBGα may be tailored to a patient’s risk profile and treatment course.

The numerically higher incidence of grade 3–4 neutropenia in the PPx group during cycle 3 should be interpreted with caution. By cycle 3, approximately 80% of patients in the SPx group had initiated EFBGα prophylaxis following neutropenia during earlier chemotherapy cycles, which may have contributed to the lower incidence observed in this group. In addition, the progressively smaller sample size in later treatment cycles may have increased the influence of random variation and limited the precision of cycle-specific estimates. Similarly, FN occurred infrequently throughout treatment, and the limited number of events precluded meaningful comparisons between prophylaxis strategies. These analyses should therefore be considered descriptive only.

Previous randomized studies of PPx with PEGylated rhG-CSF in patients with NSCLC receiving platinum–taxane chemotherapy have reported cycle 1 grade 3–4 neutropenia rates of 8.5%–14.6% with mecapegfilgrastim and 2.3%–8.9% with telpegfilgrastim25,28. Caution should be exercised regarding cross-study comparisons because our study enrolled a substantially higher-risk population. All patients in the present study had at least one additional FN risk factor, and, in comparison to prior trials, a higher proportion were aged ≥65 years (76.0% vs. 23.5%–41.2%) or had ECOG PS of 2 (40.6% vs. 0%–10.1%)25,28–30, both of which impair bone marrow reserve and increase susceptibility to CIN and FN31. Against this background, the grade 3–4 neutropenia rate of 20.6% observed with cycle 1 of EFBGα for PPx is consistent with the higher risk profile of our study population, rather than necessarily indicating inferior prophylactic efficacy. In the SPx group, grade 3–4 neutropenia rates ranged from 0.0% to 35.7% across cycles 2–4, which is wider variation than the 9.1%–12.5% reported for short-acting rhG-CSF25. This variability probably reflects population heterogeneity and the diminishing sample size in later cycles, and limits meaningful cross-study comparisons of cycle-specific rates. The FN incidence was consistent with previous reports: the cycle 1 FN incidence in the PPx group (1.6%) was comparable to that reported for PEGylated and short-acting rhG-CSF (0%–3.0%), and the incidence in the SPx group (6.1%) was similar to that reported for NSCLC cohorts without prophylactic G-CSF (5.6%–8.0%)25,28–30,32. Collectively, these findings provide clinically relevant evidence for evaluation of EFBGα effectiveness in patients with NSCLC.

EFBGα exerts its effects by activating the G-CSF receptor, which is a mechanism independent of tumor type33. Current clinical guidelines recommend G-CSF prophylaxis primarily on the basis of the myelosuppressive risk of the chemotherapy regimen34,35. Data on EFBGα are currently limited to PPx in breast cancer. In our study, the incidence rates for grade 3–4 neutropenia in cycle 1 (20.6%) and FN (3.2%) in the PPx subgroup appear to fall broadly within the range reported for neutropenia in intermediate-risk (cycle 1: 25.5%–34.2%) or high-risk regimens (cycle 1: 19.4%–75.9%; FN 1.5%–4.8%) in breast cancer20,21,24,36. Despite differences in tumor type, these findings suggest that EFBGα may provide clinically meaningful protection against CIN and FN in patients with NSCLC receiving IRC regimens, particularly in those with additional patient-related risk factors. Collectively, these results extend the evidence base for EFBGα beyond breast cancer and support its potential role as a prophylactic strategy in other solid tumors.

We observed good EFBGα tolerability, and most of the AEs observed are consistent with those expected in patients with NSCLC receiving platinum–taxane chemotherapy (e.g., anemia, a decrease in neutrophil count, and leukopenia)37,38. The higher incidence of grade ≥3 TEAEs in the SPx group was driven primarily by a substantially higher proportion of patients with a grade ≥3 decrease in neutrophil count (84.8% vs. 38.1%), which reflects the period of unprotected myelosuppression before G-CSF initiation in this group. Overall, TRAEs were consistent with the established safety profile of EFBGα, with most events being mild to moderate; pain remained a commonly reported toxicity, as observed with other G-CSF agents36,39. In the present study, 7.0% of patients receiving EFBGα experienced grade 1–2 treatment-related pain, which is comparable to or lower than the rates reported for other G-CSFs (8.5%–15.7%)30,40,41 and for EFBGα in breast cancer populations (15.7%–33.6%)24,36,42. Collectively, these findings indicate that EFBGα is well tolerated in NSCLC patients with risk factors receiving chemotherapy with intermediate FN risk, and support its use as a prophylactic strategy in this setting.

Our study has several limitations that should be acknowledged. First, the open-label design may have introduced bias in the assessment of AEs, dose modifications, and treatment decisions; however, it is likely that objective endpoint assessment and blinded statistical analyses minimized potential bias. Second, the sample size assumed 5% incidence of grade 3–4 neutropenia in the PPx group on the basis of data from a higher-risk setting; the incidence of 20.6% observed was substantially higher, which suggests that the event rate assumed during study planning underestimated the actual incidence and may have affected the precision of the power calculation. Nevertheless, the primary endpoint remained statistically significant with a clinically meaningful between-group difference. Third, a higher proportion of patients in the SPx group received concomitant immunotherapy or antiangiogenic therapy, which may have introduced additional clinical heterogeneity. Although these agents are not typically associated with grade 3–4 neutropenia, their potential influence on hematological toxicity outcomes should be considered when interpreting the results. Fourth, the study population was restricted to Chinese, chemotherapy-naïve patients with stage IIIB–IV NSCLC receiving regimens with intermediate FN risk who had additional risk factors, which may limit the generalizability of these findings to other populations, treatment settings, or chemotherapy regimens. Fifth, comparative evidence for approved G-CSF agents remains limited43, and direct comparisons between EFBGα and other agents such as pegfilgrastim and mecapegfilgrastim were beyond the scope of this study. Pharmacoeconomic outcomes were also not evaluated, despite the potential influence of drug availability, costs, patient preferences, and the healthcare-system context on G-CSF selection in clinical practice44. Finally, immunogenicity, including antidrug antibody development, was not assessed and warrants future investigation, particularly given the typical repeat-dosing context for G-CSF agents. Taken together, these limitations indicate that future head-to-head studies incorporating assessments of comparative effectiveness, cost effectiveness, real-world accessibility, and immunogenicity are warranted to further characterize the clinical value and appropriate use of EFBGα.

Conclusions

In conclusion, this randomized phase II study provides preliminary evidence that EFBGα is a potentially effective and well-tolerated prophylactic strategy against CIN in patients with NSCLC receiving regimens with intermediate FN risk who have additional risk factors. Earlier initiation of prophylaxis was associated with lower rates of grade 3–4 neutropenia. The findings support further evaluation of EFBGα in larger comparative phase III trials.

Conflict of interest statement

The funding organization for the study provided the study drug and support for data collection and management. Data collection for the trial was conducted by the site management organizations Jiangsu Shiyan Pharmaceutical Technology Co., Ltd., Suqian, China; SMS Clinicalstudies Co., Ltd., Beijing, China; and Zhejiang Taimei Medical Technology Co., Ltd., Jiaxing, China, which were engaged by the Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Jiangsu, China. The funding organization had no role in study design, data analysis, data interpretation, or manuscript writing. All authors had full access to all the study data and had final responsibility for the decision to submit for publication. The authors declare that they have no other competing interests.

Author contributions

Conceptualization: Mengjie Li, Caixia Liu, Dingzhi Huang.

Resources: Mengjie Li, Caixia Liu, Fengming Ran, Haitao Lan, Jun Ge, Zheng Zhao, Chuangzhou Rao, Wei Zheng, Xiaoyong Tang, Tianhui Gao, Yong Mao, Wei Cui, Zhengguo Li, Dingzhi Huang.

Data curation: Mengjie Li, Caixia Liu, Fengming Ran, Haitao Lan, Jun Ge, Zheng Zhao, Chuangzhou Rao, Wei Zheng, Xiaoyong Tang, Tianhui Gao, Yong Mao, Wei Cui, Zhengguo Li, Dingzhi Huang.

Formal analysis: Mengjie Li, Caixia Liu, Dingzhi Huang.

Visualization: Fengming Ran, Haitao Lan, Jun Ge, Zheng Zhao, Chuangzhou Rao, Wei Zheng, Xiaoyong Tang, Tianhui Gao, Yong Mao, Wei Cui, Zhengguo Li.

Writing–original draft: Mengjie Li, Caixia Liu, Dingzhi Huang.

Writing–review and editing: Mengjie Li, Caixia Liu, Dingzhi Huang.

Data availability statement

The data generated in this study are available on request from the corresponding author.

Acknowledgments

This study was funded by the Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Jiangsu, China. We thank the patients and their families who participated in this trial, as well as all the research personnel and site staff who were involved in this work.

  • Received April 18, 2026.
  • Accepted August 13, 2026.

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