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SI-B001 + osimertinib is an investigational combination therapy being studied primarily for non-small cell lung cancer (NSCLC), particularly in patients who have progressed after prior EGFR-TKI treatment, those with non–TKI-sensitizing EGFR mutations, or EGFR exon20 insertion mutations. SI-B001 (also known as izalontamab) is a bispecific antibody that targets both EGFR (epidermal growth factor receptor) and HER3 (also known as ERBB3), disrupting both EGFR homodimer and EGFR-HER3 heterodimer formation and enhancing receptor down-regulation. Osimertinib is a third-generation, irreversible, oral EGFR tyrosine kinase inhibitor (TKI) that selectively inhibits EGFR-sensitizing mutations and the T790M resistance mutation. The combination is being evaluated in multi-center, open-label phase II/III clinical trials for safety, efficacy, and optimal dosing in NSCLC.
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