暴涨69.85%!断腕减肥, 豪赌白血病,Terns 宣布 Tern-701 在复发/难治性 CML 一期临床中取得突破疗效!

Core Insights - Terns Pharmaceuticals experienced a significant stock price surge of 69.85% on November 3, 2025, due to promising clinical data for its chronic myeloid leukemia (CML) therapy, TERN-701, which is set to be presented at the upcoming ASH annual meeting [1][29]. Group 1: Clinical Data and Efficacy - TERN-701 is a highly selective BCR-ABL allosteric inhibitor, demonstrating over 10,000 times selectivity for ABL1 and ABL2 compared to other active site TKIs, which is 450 times higher than other inhibitors [3]. - The clinical trial for TERN-701 included 80 patients, with data from 55 patients presented at ASH, showing a remarkable 75% overall major molecular response (MMR) rate at 24 weeks, which is at least double the historical data of other products [15][20][29]. - Among patients who had previously failed other treatments, TERN-701 achieved a 69% MMR rate, and 60% in those who had prior asciminib treatment, indicating its effectiveness in heavily pre-treated populations [20][30]. Group 2: Market Context and Competitive Landscape - The current standard treatment for CML includes active site TKIs and allosteric TKIs like Asciminib, which has a peak sales forecast exceeding $3 billion, yet there remains a significant unmet clinical need as many patients do not achieve MMR [5][9]. - TERN-701's clinical data suggests it could potentially shift the treatment paradigm for CML, especially for patients with T315I mutations, who currently have limited options [30][34]. - The ability of TERN-701 to achieve high MMR rates in difficult-to-treat patients positions it as a potential best-in-class therapy in the CML market, which is characterized by a high unmet need [31][34]. Group 3: Company Strategy and Future Prospects - Terns Pharmaceuticals has shifted its focus from metabolic diseases to cancer therapies, particularly TERN-701 for CML, as it seeks to capitalize on the significant market opportunity in this area [32][34]. - The company plans to advance TERN-701 rapidly through clinical phases, with the potential to move directly from Phase 1 to Phase 3 trials due to the compelling clinical data [23][35]. - Despite the promising data, the company acknowledges the inherent risks in biotechnology investments, as TERN-701 is still in clinical development and faces several regulatory hurdles before potential approval [32].