PD-(L)1/VEGF赛道攻坚，依沃西冲击首个海外适应症

Core Viewpoint - Summit Therapeutics plans to submit a Biologics License Application (BLA) to the FDA in Q4 2025 for evorpacept in combination with chemotherapy for EGFR mutation non-squamous non-small cell lung cancer (NSCLC) patients who have progressed after third-generation EGFR-TKI treatment, marking a significant step in the drug's overseas commercialization efforts [1][2]. Group 1: Clinical Trial Results - The decision to submit the BLA is based on the positive results from the global Phase III clinical trial HARMONi, which achieved its primary endpoint of progression-free survival (PFS) [1]. - Updated data from the HARMONi study showed an improvement in overall survival (OS) with a hazard ratio (HR) of 0.78 (p=0.0332) for the intention-to-treat (ITT) population, particularly notable in the North American cohort with an HR of 0.70 [2]. - The median overall survival (mOS) for the evorpacept group was reported at 16.8 months compared to 14 months for the control group, with a HR of 0.79 [1]. Group 2: Commercialization and Partnerships - In December 2022, a collaboration agreement worth up to $5 billion was established between Kangfang Biopharma and Summit Therapeutics for the development and commercialization of evorpacept in key markets including the US, Canada, Europe, and Japan [3]. - A supplemental licensing agreement was signed in June 2024, expanding Summit's rights to develop and commercialize evorpacept in additional markets including China, South America, the Middle East, and Africa, with Kangfang receiving a $70 million upfront payment [3]. Group 3: Industry Context and Future Prospects - The development of PD-(L)1/VEGF dual-targeted therapies is seen as a critical advancement in cancer treatment, addressing limitations of existing therapies [7][8]. - The success of evorpacept in clinical trials has sparked renewed interest and investment in the PD-(L)1/VEGF space, with significant cross-border transactions indicating the global market's recognition of the drug's potential [8][9]. - The ongoing clinical exploration of evorpacept is expected to accelerate, with Summit planning to initiate new Phase III trials targeting additional indications [6].