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P3.18.46 Ivonescimab Plus Platinum-Doublet Chemoth ...
P3.18.46 Ivonescimab Plus Platinum-Doublet Chemotherapy as First-Line Therapy for Locally Advanced/Metastatic SMARCA4-Deficient NSCLC
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This poster presents a Phase 2 clinical study investigating the efficacy and safety of ivonescimab combined with platinum-doublet chemotherapy as first-line treatment for locally advanced or metastatic SMARCA4-deficient non-small cell lung cancer (SMARCA4-dNSCLC). SMARCA4-dNSCLC is a rare and aggressive lung cancer subtype with a poor prognosis, commonly affecting young to middle-aged male smokers, characterized by rapid growth, early metastasis, and resistance to current chemotherapy, targeted therapies, and immunotherapy. No standard treatment exists for this subgroup.<br /><br />Ivonescimab is a novel bi-specific antibody targeting PD-1 and VEGF, aiming to enhance anti-tumor efficacy through immune checkpoint inhibition and anti-angiogenesis. The study enrolled patients aged 18-75 years with SMARCA4-dNSCLC, EGFR/ALK wild-type status, ECOG performance status 0-1, and any PD-L1 status, including those with asymptomatic brain metastases.<br /><br />Patients received ivonescimab (20 mg/kg) plus albumin-bound paclitaxel and carboplatin on a 3-week cycle for 4-6 cycles, followed by ivonescimab maintenance every 3 weeks. Key inclusion criteria mandated measurable disease per RECIST 1.1 and no prior systemic treatment for advanced disease. Exclusions included active CNS metastases, tumor involving vital structures with risk of fistula, significant effusions, coagulation disorders, or high bleeding risk.<br /><br />Primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate, duration and time to response, disease control rate, overall survival, and safety. Exploratory outcomes measured health-related quality of life. Tumor assessments were conducted every 6 weeks for the first 48 weeks, then every 12 weeks, with adverse events monitored continuously.<br /><br />The study utilizes full analysis sets for efficacy and safety analyses to assess the potential of ivonescimab plus chemotherapy as a novel therapeutic approach for this challenging lung cancer subtype. The results could provide important insights for establishing effective first-line therapies targeting SMARCA4-dNSCLC.
Asset Subtitle
Yuan Liang
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Speaker
Yuan Liang
Topic
Clinical Trials in Progress
Keywords
SMARCA4-deficient non-small cell lung cancer
ivonescimab
platinum-doublet chemotherapy
phase 2 clinical study
PD-1 and VEGF bi-specific antibody
first-line treatment
progression-free survival
immune checkpoint inhibition
anti-angiogenesis
tumor response assessment
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