医药行业周专题：EGFR突变NSCLC一线治疗步入新时期

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry in China [1]. Core Insights - The FDA has approved the combination therapy of Amivantamab (EGFR x c-MET bispecific antibody) with Lazertinib for first-line treatment of EGFR-sensitive mutations in advanced non-small cell lung cancer (NSCLC), challenging the previous standard of care, Osimertinib [6][12]. - Combination therapies have shown significant progression-free survival (PFS) benefits compared to Osimertinib monotherapy, indicating a shift in treatment paradigms [6][12]. - The report emphasizes the importance of patient selection due to the higher toxicity associated with combination therapies compared to monotherapy [28][29]. Summary by Sections 1. Approval of Combination Therapies - The FDA approved Amivantamab combined with Lazertinib for first-line treatment of EGFR-sensitive mutations in NSCLC on August 19, 2024, following the earlier approval of Osimertinib combined with chemotherapy [12][21]. - Clinical studies (MARIPOSA and FLAURA2) demonstrate that these combination therapies provide superior PFS compared to Osimertinib alone, with significant improvements in median PFS and duration of response [12][13]. 2. Future Outlook for EGFR Mutation NSCLC Treatment - The report discusses the trend towards personalized treatment and the emergence of multiple combination therapies, highlighting the need for careful patient selection due to varying safety profiles [26][28]. - Ongoing clinical trials are exploring new combinations and the potential benefits for specific patient subgroups, such as those with brain metastases or specific EGFR mutations [30][31]. 3. Investment Recommendations and Targets - The report suggests focusing on companies actively exploring combination therapies in the EGFR mutation NSCLC space, including Hansoh Pharmaceutical, Elysium, Betta Pharmaceuticals, and others [4][6]. - The report indicates that the landscape for first-line treatment is evolving, with more options available, but emphasizes the need for ongoing assessment of safety and efficacy [26][28].