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国产双抗碾压药王！肺癌无进展生存率翻倍

发布于 2025-08-29

<p data-pm-slice="0 0 []"><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">摩根大通（J.P. Morgan）亚太股票2025年8月15日研究报告《中国生物医药：我们对2025年世界肺癌大会的关注将集中在伊沃普单抗HARMONI三期数据上》的主要内容总结：</span></span></span></span></p><p><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">核心主题：</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;报告聚焦于即将在2025年9月6-9日举行的世界肺癌大会（WCLC 2025），重点关注会议摘要中披露的关键中国生物医药公司的肺癌领域临床研究数据，特别是康方生物（Akeso）的伊沃普单抗（Ivonescimab）的III期数据。</span></span></span></span></p><p><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">关键发现与关注点：</span></span></strong></span></span></p><ol class="list-paddingleft-1"><li><span data-marker="1."></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">康方生物 (Akeso) - 伊沃普单抗 (Ivonescimab):</span></span></strong></span></span></li></ol><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">HARMONi 全球 III 期试验 (EGFR+ NSCLC 后线治疗):</span></span></strong></span></span></li></ul><ul style="list-style-type: circle;" class="list-paddingleft-1"><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">试验设计:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;Ivonescimab + 化疗 vs. 单纯化疗，用于接受过第三代EGFR-TKI治疗后进展的EGFR阳性非小细胞肺癌（NSCLC）患者。</span></span></span></span></section></li><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">重要性:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;该研究的报告被选为“总统研讨会”（Presidential Symposium）的口头报告，该环节通常展示可能改变临床实践的关键创新研究。</span></span></span></span></section></li><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">已知结果 (2025年5月公布):</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;无进展生存期（PFS）具有高度统计学显著性；总生存期（OS）显示出积极趋势，但略微未达到统计学显著性。</span></span></span></span></section></li><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">WCLC关注点:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;市场将重点关注中国患者与海外患者的PFS数据一致性，以及整体安全性（特别是出血风险）。</span></span></span></span></section></li></ul><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">HARMONi-2 中国 III 期试验 (PD-L1+ NSCLC 一线治疗):</span></span></strong></span></span></li></ul><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">试验设计:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;Ivonescimab 单药 vs. Keytruda (帕博利珠单抗)，用于PD-L1阳性NSCLC患者的一线治疗。</span></span></span></span></li></ul><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">亚组分析结果:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"></span></span></span></li></ul><ul style="list-style-type: circle;" class="list-paddingleft-1"><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">PD-L1表达水平:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;Ivonescimab 在 PD-L1 TPS ≥50% 患者中的表现优于 Keytruda（PFS HR=0.48），优于在 PD-L1 TPS 1-49% 患者中的表现（PFS HR=0.54）。</span></span></span></span></section></li><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">组织学类型 (鳞癌 vs. 非鳞癌):</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;在鳞癌和非鳞癌患者中均显示出PFS获益（HR分别为0.50和0.55）。在PD-L1 TPS 1-49%的非鳞癌患者中，HR更低（0.43）。客观缓解率（ORR）在鳞癌患者中优势更明显（53% vs. 31%）。</span></span></span></span></section></li><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">安全性:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;整体严重治疗相关不良事件（Serious TRAEs）发生率相似。</span></span></span></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">需注意:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;在非鳞癌患者中，Ivonescimab组的3级出血发生率更高（9例 vs. Pembrolizumab组1例）。在PD-L1 TPS 1-49%组，Ivonescimab组的严重TRAEs发生率也更高（20% vs. 11%）。</span></span></span></span></section></li></ul><ol class="list-paddingleft-1" start="2"><li><span data-marker="2."></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">康方生物 (Akeso) - 卡度尼利单抗 (Cadonilimab, AK104) + 普洛西姆单抗 (Pulocimab, AK109) 双抗组合:</span></span></strong></span></span></li></ol><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">Ib/II期研究 (二线 NSCLC):</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"></span></span></span></li></ul><ul style="list-style-type: circle;" class="list-paddingleft-1"><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">在二线鳞状NSCLC患者中观察到显著的疗效：中位OS 16.7个月，中位PFS 7.1个月，均高于非鳞癌亚组（OS 12.8个月，PFS 5.5个月）。</span></span></span></span></section></li><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">报告认为，该双抗组合在一线免疫治疗（I/O）+化疗失败后的二线EGFR野生型NSCLC患者中，可能比化疗更具潜力。</span></span></span></span></section></li></ul><ol class="list-paddingleft-1" start="3"><li><span data-marker="3."></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">复宏汉霖 (Henlius) - HLX43 (PD-L1 ADC):</span></span></strong></span></span></li></ol><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">I期研究更新 (NSCLC):</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"></span></span></span></li></ul><ul style="list-style-type: circle;" class="list-paddingleft-1"><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">在二线及以上NSCLC患者中，总体客观缓解率（ORR）约为32%。</span></span></span></span></section></li><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">在一小部分EGFR野生型非鳞状NSCLC患者（n=19）中，ORR达到47%，远高于标准治疗。</span></span></span></span></section></li></ul><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">疑问点:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;报告指出需要进一步了解为何在剂量高于2.5 mg/kg的组中，ORR较低（26%），而2 mg/kg组为38%，2.5 mg/kg组为33%。</span></span></span></span></li></ul><ol class="list-paddingleft-1" start="4"><li><span data-marker="4."></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">君实生物 (Junshi) &amp; 百济神州 (BioNTech):</span></span></strong></span></span></li></ol><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">君实:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;公布了其Tifemcalimab（TIGIT单抗） + Toripalimab（PD-1单抗） + 化疗在广泛期小细胞肺癌（ES-SCLC）一线治疗的Ib/II期研究结果。在43名可评估患者中，15个月OS率为63.5%，提示中位OS（mOS）可能达到18个月或更高，若实现将优于标准治疗。</span></span></span></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">关注点:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;安全性问题仍需关注（报告提及有疑问）。</span></span></span></span></li></ul><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">百济神州:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;报告了其BNT327（Pumamitam, DLL3 ADC）联合化疗在全球II期研究（ES-SCLC一线治疗）中的ORR数据（具体数值未提供）。</span></span></span></span></li></ul><ol class="list-paddingleft-1" start="5"><li><span data-marker="5."></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">中国生物制药 (Sino Biopharm) - TQB2102 (HER2 ADC):</span></span></strong></span></span></li></ol><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">II期试验初步结果 (HER2异常NSCLC):</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"></span></span></span></li></ul><ul style="list-style-type: circle;" class="list-paddingleft-1"><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">试验分为三个队列：HER2突变（组1）、HER2基因扩增或蛋白过表达（IHC 2+/3+）（组2）、HER2+EGFR突变（组3）。</span></span></span></span></section></li><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">ORR分别为：组1 61%，组2 44%，组3 100%。这与Enhertu（德曲妥珠单抗）在DESTINY-Lung02试验中的ORR（49-56%）相当。</span></span></span></span></section></li><li><section><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">安全性:</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;TQB2102组67%的患者经历了3级或以上TRAEs（Enhertu 5.4mg/kg和6.4mg/kg组分别为39%和58%）。TQB2102的间质性肺病（ILD）发生率（3.3%）远低于Enhertu（12.9%和28%）。</span></span></span></span></section></li></ul><ol class="list-paddingleft-1" start="6"><li><span data-marker="6."></span><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">其他提及但信息有限的研究:</span></span></strong></span></span></li></ol><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">许多摘要仅介绍了试验方法或处于信息保密（embargo）状态。例如：&nbsp;</span></span></span></span></li></ul><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">康方生物的AK112（PD-1/VEGF双抗）+化疗在SMARCA4缺陷型NSCLC和胸腺癌中的应用。</span></span></span></span></li></ul><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">恒瑞医药（Hengrui）的DLL3 ADC SHR-4849在复发性SCLC患者中的首次人体（FIH）I期研究。</span></span></span></span></li></ul><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">百济神州的BNT324（未说明靶点）联合BNT327（DLL3 ADC）在肺癌中的Ib/II期试验。</span></span></span></span></li></ul><ul class="list-paddingleft-1"><li><span data-marker=""></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-zero-width="n" data-slate-length="0"></span></span></span></li></ul><p><span data-slate-node="text"><span data-slate-leaf="true"><strong><span data-slate-string="true"><span leaf="">总结：</span></span></strong></span></span><span data-slate-node="text"><span data-slate-leaf="true"><span data-slate-string="true"><span leaf="">&nbsp;这份报告的核心在于预览WCLC 2025上中国生物医药公司的重要肺癌数据发布，尤其是康方生物的伊沃普单抗在全球和中国关键III期试验的详细数据（疗效一致性、安全性），以及其他公司（康方双抗、复宏汉霖ADC、君实/百济组合、中国生物制药ADC）在肺癌领域（NSCLC和SCLC）的最新临床进展。</span></span></span></span></p><section><span leaf=""><br /></span></section><p style="display: none;"><mp-style-type data-value="3"></mp-style-type></p>

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