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The addition of nimotuzumab to chemotherapy led to improvements in progression-free survival (PFS) and overall survival (OS) vs chemotherapy alone for the first-line treatment of patients with recurrent or persistent cervical cancer, according to data from a phase 3 study (NCT06781073) presented during the 2025 ASCO Annual Meeting.1
Patients who received the combination (n = 55) achieved a median OS of 15.7 months (95% CI, 11.8-26.9) compared with 12.4 months (95% CI, 7.9-21) among patients who received placebo plus chemotherapy (n = 63; HR, 0.72; 95% CI, 0.46-1.11). The median PFS was 7.4 months (95% CI, 4.9-8.9) vs 5.6 months (95% CI, 4.1-6.1), respectively (HR, 0.66; 95% CI, 0.42-1.05).
“[Findings from] our study showed that the incorporation of nimotuzumab into chemotherapy [for] the first-line treatment of [patients with] recurrent or persistent could [lead to] an improvement of PFS and OS,” Zexuan Liu, MD, of the Department of Gynecologic Oncology, National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, said during the presentation.
Phase 3 Study Design and Baseline Characteristics
The multicenter, double-blind trial enrolled patients 18 to 75 years old with histologically confirmed cervical cancer. Patients needed to have stage IVB or first recurrent or persistent cervical cancer per FIGO 2018 criteria, measurable primary tumors per RECIST 1.1 criteria, an ECOG performance status of 0 or 1, a life expectancy of at least 3 months, and adequate organ function.
Eligible patients were randomly assigned 1:1 to receive nimotuzumab at 400 mg per week for 18 weeks followed by maintenance nimotuzumab at 400 mg every 2 weeks for 60 weeks or matching placebo. Patients in both arms also received paclitaxel and cisplatin every 3 weeks for up to 6 cycles. Treatment in both arms continued until disease progression or intolerable toxicity.
The primary end point was OS. Secondary end points included PFS, overall response rate, and quality of life measure.
At baseline, the median age in the overall population (n = 118) was 51.2 years (SD, 9.66). Most patients underwent maintenance therapy for less than 24 weeks (90.68%), had FIGO stage disease other than IV (85.59%), and received concurrent chemoradiotherapy (52.54%). Patients had poorly- (31.36%), moderately- (27.97%), and well-differentiated (4.24%) disease; 36.44% of patients had unknown disease differentiation.
Additional Efficacy Findings and Safety Data
Additional findings from the phase 3 study revealed that patients with recurrent disease in the investigational (n = 51) and placebo (n = 58) arms achieved a median OS of 21.7 months (95% CI, 21.1-32.9) and 12.4 months (95% Ci, 8-21.4), respectively (HR, 0.62; 95% CI, 0.39-0.98; P = .04). An OS benefit was observed in most of the prespecified subgroups; the most significant benefits in favor of the nimotuzumab arm were reported among patients of the age of 60 years (HR, 0.48; 95% CI, 0.13-1.83; P = .28), those with poorly differentiated disease (HR, 0.55; 95% CI, 0.24-1.27; P = .16), and those with more than 1 organ lesion (HR, 0.65; 95% CI, 0.36-1.20; P = .17).
In terms of safety, grade 3 or higher adverse effects (AEs) occurred at rates of 78.2% and 71.4% in the investigational and control arms, respectively. Serious AEs (14.5% vs 20.6%) were reported in both arms. Notably, no AEs leading to death occurred in either arm. The most common AEs in the nimotuzumab arm included anemia (41.8%), leukopenia (36.4%), nausea (29.1%), and alopecia (20.0%). These AEs were reported at rates of 0%, 26.9%, 30.0%, and 31.7%, respectively, in the control arm.
The most common grade 3 or higher treatment-related AEs (TRAEs) in the nimotuzumab arm included neutropenia (69%), leukopenia (47%), decreased hemoglobin levels (5%), and decreased platelet counts (5%). The most common grade 3 or higher TRAEs in the control arm included neutropenia (49%), leukopenia (32%), and hypertension (6%).
“The combination therapy demonstrated well-tolerated toxicity,” Liu said. “We believe that nimotuzumab combined with chemotherapy can be considered as a potential first-line therapy option [for patients with] recurrent or persistent cervical cancer.”
Disclosures: Liu listed no disclosures.
Reference
An J, Wang J, Wang C, et al. Nimotuzumab combined with chemotherapy in the first-line treatment for patients with stage IVB, recurrent or persistent cervical squamous cell carcinoma: a multi-center, randomized, double-blind, and controlled study. J Clin Oncol. 2025;43(suppl 16):5510. doi:10.1200/JCO.2025.43.16_suppl.5510