The FDA action date for its regulatory decision is anticipated during the third quarter of this year. Dr. Liu shares his insights on the recent announcement that the phase 3 trial met its secondary endpoint of overall survival. The phase 2 trial included patients who had advanced or metastatic NSCLC with actionable genomic alterations. Sunvozertinib is an irreversible EGFR inhibitor that targets a wide spectrum of EGFR mutations. For patients with NSCLC and EGFR mutations, amivantamab plus carboplatin-pemetrexed shows OS benefits versus chemo alone. The improvement in median OS with the combination treatment is “expected to exceed one year," officials said. The study showed there was “preliminary evidence of central nervous system-anti-tumor activity” in some patients. This follows the FDA’s August 2024 move to grant Priority Review for the subcutaneous amivantamab BLA. The real-world study is the first to provide an overview of EGFR mutations and subtype prevalence in patients with NSCLC. The real-world study was presented at the IASLC 2024 World Conference on Lung Cancer. The approval is based on results from the phase 3 LAURA trial. The efficacy of the combination was evaluated in the randomized, open-label, multicenter MARIPOSA-2 trial. Benjamin Besse, MD, PhD, shares insights from the research he presented as a late-breaking abstract at ESMO 2024. The study evaluated multiple prophylactic strategies to mitigate infusion-related reactions with IV amivantamab. Rilertinib showed significantly longer progression-free survival compared with gefitinib. Shirish M. Gadgeel, MD, discusses his presentation on the updated data, with a median follow-up of 31.1 months. Osimertinib demonstrated a manageable safety profile for the treatment of stage III EGFR-mutated NSCLC. Samantha Armstrong, MD, and Karine Tawagi, MD, interview Dr. Ramalingam about his plenary presentation. The results may establish osimertinib as the new standard of care for EGFR-mutated NSCLC in a certain setting.