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转移性肺鳞癌在PD-L1抑制剂+铂类化疗进展后，长期陷入<span text="">无药可选、生存极差</span><span text="">的困境。</span><div><span text="">全球多中心Ⅲ期PRESERVE-003研究初步结果于</span><span text="">《</span><span text="">Nature Medicine</span><span text="">》</span><span text="">杂志上</span><span text="">发表，该研究</span><span text="">首次证实新型pH敏感CTLA-4单抗Gotistobart单药完胜多西他赛</span><span text="">，为这一最难治人群带来颠覆性突破。</span><div><br><section data-layout-id="1"><span leaf=""><span text="">本研究纳入</span><span text="">既往PD-L1抑制剂联合铂类化疗失败</span><span text="">、无驱动基因突变的转移性肺鳞癌患者，1:1随机接受gotistobart（45例）或多西他赛（42例）。中位随访14.5个月。</span></span></section><section data-layout-id="1"><span text=""><br></span></section><section data-layout-id="1"><span text="">✅ </span><span text="">生存</span><span text="">：Gotistobart组</span><span text="">中位OS未达到</span><span text="">，多西他赛组仅10.0个月；</span><span text="">死亡风险降54%</span><span text="">（HR=0.46，P=0.0102）；12个月OS率</span><span text="">63.1% vs 30.3%</span><span text="">。</span></section><section nodeleaf=""><span class="wxart_image" wx-="">
</span></section><section data-layout-id="3"><span leaf=""><span text="">✅ </span><span text="">缓解</span><span text="">：确认ORR</span><span text="">20.0% vs 4.8%</span><span text="">，缓解深度与有效率全面超越化疗；中位缓解持续时间</span><span text="">11.0个月 vs 3.8个月</span><span text="">，免疫长效优势显著。</span></span></section><section nodeleaf=""><span class="wxart_image" wx-="">
</span></section><section data-layout-id="4"><span leaf=""><span text="">✅ </span><span text="">长期获益</span><span text="">：12个月PFS率</span><span text="">25.2% vs 0%</span><span text="">。</span></span></section><section nodeleaf=""><span class="wxart_image" wx-="">
</span></section><section data-layout-id="5"><span leaf=""><span text="">安全性方面，Gotistobart </span><span text="">≥3级治疗相关不良事件发生率</span><span text="">42.2%</span><span text="">，</span><span text="">低于多西他赛的48.8%</span><span text="">；主要不良反应为腹泻、转氨酶升高，无治疗相关死亡，整体耐受性更优。</span></span></section><section data-layout-id="6"><br></section><section data-layout-id="7"><span leaf=""><span text="">经数据监查委员会评估，</span><span text="">仅肺鳞癌人群获益显著</span><span text="">，研究已聚焦该人群进入关键Ⅱ期验证阶段。</span></span></section><section data-layout-id="8"><br></section><section data-layout-id="10"><span leaf=""><span text="">参考文献：</span></span></section><section data-layout-id="10"><span leaf=""><span text="">Cho BC, Balaraman R, Chen HJ, et al. Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. Nat Med. Published online March 27, 2026. doi:10.1038/s41591-026-04323-8</span></span></section><p><mp-style-type data-value="3"></mp-style-type></p><p></p></div></div> |
