Core Viewpoint - Goldman Sachs released a report on the preliminary Phase 1 study data of CS2009 (a PD-1/VEGF/CTLA-4 tri-specific antibody) presented at the ESMO 2025 conference, indicating good safety and early tumor response signals across various cancer types, supporting further research on this asset [1] Group 1: Safety and Tolerability - CS2009 demonstrated good tolerability during the dose escalation study involving 72 patients across six dosage levels (1/3/10/20/30/45 mg/kg) [2] - In comparison, the HARMONi-2 trial showed that ivonescimab (PD-1/VEGF dual antibody) had a 29% incidence of grade 3 or higher treatment-related adverse events (TRAE) and 7% for immune-related adverse events (irAE) [2] - Higher dose groups experienced fewer adverse reactions, potentially due to shorter observation times, as some adverse reactions may take 4-8 weeks to manifest [2] Group 2: Competitive Potential in NSCLC - Among 49 patients who underwent at least one tumor assessment, partial responses were observed in seven patients across five cancer types, indicating preliminary pan-cancer potential for CS2009 [3] - Notably, in 12 IO-treated NSCLC patients without prior anti-angiogenic therapy, CS2009 showed a 25% objective response rate (ORR) and an 83% disease control rate (DCR), suggesting positive evidence for further research in NSCLC [3] - For context, other treatments like cadonilimab and BNT327 showed ORR/DCR of 13%/96% and 12.5%/62.5% respectively in similar patient populations [3] Group 3: Future Development Plans - The management plans to select the recommended Phase 3 dose from 20 mg/kg and 30 mg/kg based on Phase 1 data, aiming to initiate a global Phase 3 trial by the end of 2026 for NSCLC treatment [4] - A recently launched Phase 2 trial in Australia and China has over 30 clinical centers initiated, with patient enrollment expected to start soon [4] - Goldman Sachs adjusted the earnings per share forecast for the company from RMB -0.21/-0.7/0.09 to RMB -0.22/1.07/0.01, reflecting an increased view on CS2009's success probability from 30% to 49% [4]
高盛：点评基石药业-B(02616)三抗ESMO数据 予“买入”评级 升目标价至7.05港元