P76.75 Clinical Outcome and Toxicity Profiles of Patients with EGFR-mutation Positive Non-Small-Cell Lung Cancer

Abstract

treatment for locally advanced or metastatic disease, history of leptomeningeal disease, interstitial lung disease, and prior treatment with an EGFR TKI. Approximately 1000 patients will be randomly assigned 2:2:1 to receive amivantamab + lazertinib (nw400), osimertinib (nw400), or lazertinib (nw200). Randomization will be stratified by mutation type (Exon19del vs L858R), race (Asian vs non-Asian), and history of brain metastases (present vs absent). Patients in the combination arm will receive open-label treatment with amivantamab (1050 mg [1400 mg, patients 80 kg] intravenously once weekly for the first 4 weeks, every 2 weeks thereafter) + lazertinib (240 mg oral daily). Patients in the single-agent osimertinib and lazertinib arms will receive double-blind treatment (80 mg or 240 mg oral daily, respectively). The primary endpoint of the study is progression-free survival (PFS) based on blinded independent central review according to RECIST v1.1. To assess the contribution of amivantamab to the efficacy of the combination, comparison of the combination and monotherapy lazertinib arms will also be performed. Secondary endpoints include overall survival, objective response rate, duration of response, PFS after first subsequent therapy, time to symptomatic progression, and intracranial PFS. Safety assessments will include monitoring adverse events and laboratory abnormalities.

Lung Cancer in Pakistan

“…A recent real-world data study from a tertiary care center on EGFR-mutant lung carcinoma highlights the prevalence, diagnosis, challenges, and outcomes of EGFR tyrosine kinase inhibitors in the Pakistani population. 25 Immunotherapy, that is, checkpoint inhibitor, is largely limited to atezolizumab, which is the only registered product in the country at present.…”