Pumitamig

点击蓝字 关注我们 本 期 看 点 已经有多款PD-1/VEGF双抗获得BD，聚焦于PD-L1/VEGF双抗的企业，普米斯已经实现BD，且近期公布了令人惊艳的ORR数据。近日，本号也聚焦即将公布数据的全球第二款PD‑L1/VEGF双抗, 肺癌数据公布，子宫内膜癌进入三期，华海能等来BD吗？从直观感受来看，PD-L1和VEGF都高表达于肿瘤微环境，会否缩瘤效果要明显优于PD-1/VEGF双抗，而随着FDA开始强调OS才是临床治疗成功并转化为适应症获批的“金标准”之后，ORR显著获益后期能否转化为OS获益，则是最值得探讨的事情。本文将围绕PD-L1/VEGF双抗最新临床数据与竞品格局展开，深入分析其短期缩瘤优势以及在后PD-1时代监管环境中的定位，并探讨国内候选药物HB0025的潜在出海前景。 本期内容 01 BioNTech/施贵宝丨Pumitamig 02 华海药业丨PD‑L1/VEGF双抗 03 华海药业HB0025的前景展望 04 FDA监管新动向：OS重要性提升 【01 BioNTech/施贵宝丨Pumitamig】 2025年6月2日，BioNTech SE和施贵宝宣布两家公司已达成协议，将在全球范围内共同开发和共同商业化BioNTech的PD-L1/VEGF双抗BNT327，用于多种实体瘤类型。令人咋舌的是其合作总金额，到2028年，BMS将向BioNTech支付15亿美元的预付款和20亿美元的非或有周年付款。所以，再提普米斯已经不合适了。 Pumitamig丨2025WCLC数据惊艳 BNT327为一款双特异性抗体药物，由人源化的抗PD-L1单域抗体（VHH）融合到一个含有Fc-沉默突变的抗VEGF-A IgG1抗体上构成，现已在国内开展针对三阴乳腺癌、小细胞肺癌、非小细胞肺癌、宫颈癌、肝癌等多个瘤种的多项II期和III期临床研究。 2025年9月8日，BioNTech 及其合作伙伴BMS发布了他们针对小细胞肺癌 (SCLC) 的 PD-L1xVEGF 双特异性抗体 pumitamig (BNT327/BMS986545) 全球首批临床数据，BioNTech 首席医疗官 Özlem Türeci 博士表示，这些发现与该药物此前在中国获得的成果非常一致。 pumitamig联合化疗在中国SCLC患者的Ⅱ期研究中显示出令人鼓舞的活性。在2025WCLC大会上，报告了首个来自全球人群的pumitamig研究结果。 这是一项全球性、Ⅱ期、随机、开放标签、平行分组的临床试验（NCT06449209）。 队列1（Cohort 1，初治ES-SCLC）：接受pumitamig + 依托泊苷 + 卡铂治疗，共4个周期，随后进行pumitamig维持治疗。 队列2/3（Cohort 2/3，1线或2线治疗失败后进展）：分别接受pumitamig + 紫杉醇或pumitamig + 拓扑替康。 各队列内患者被随机分配接受pumitamig 20或30 mg/kg，静脉给药，每3周一次（IV Q3W），治疗最长可达2年，或直至疾病进展/不可耐受毒性。主要终点为依据RECIST 1.1评估的疗效（研究者评估的ORR、肿瘤体积变化与早期肿瘤缩小）以及依据NCI CTCAE v5.0评估的安全性。采用FoundationOne® Liquid CDx检测循环游离DNA（cfDNA）中循环肿瘤组分（TFx）。本文重点呈现队列1的数据，以及用于支持Ⅲ期开发的最优剂量确定。 结果： 截至数据截点2025年4月4日，共入组107例患者。 队列1（N=43）：在38例可评估疗效的患者中，33例为PR、5例为SD，未确认ORR（uORR）为86.8%，DCR为100%。肿瘤体积最佳平均相对变化为-47.3%，89.5%的患者出现早期肿瘤缩小。 分剂量看，uORR分别为：20 mg/kg组95.0%，30 mg/kg组77.8%。 在11例具有≥2次基线后肿瘤评估且随访>90天的患者中，确认ORR总体为81.8%（9/11）；分剂量分别为：20 mg/kg组100%（6/6），30 mg/kg组60.0%（3/5）。缓解持续时间（DoR）与无进展生存期（PFS）尚未成熟，更新的疗效数据（包括早期DoR与PFS）将另行报告。 ctDNA：基线ctDNA检出率为93.8%（在有cfDNA数据的32例中30例检出），基线中位TFx为57.0%。在第3周期第1天（C3D1），所有可评估患者（n=18）相较基线均出现ctDNA下降，中位TFx变化为-99.3%，ctDNA清除率为44.4%（8/18）；两剂量组间结果相近。 安全性：与任一治疗相关的不良事件（AE）发生于35/43（81.4%）例，其中23例（53.5%）为≥3级。与pumitamig相关的≥3级AE在20 mg/kg组1例、30 mg/kg组5例，具体包括高血压（n=2）、血小板计数减少、咯血、蛋白尿与肺栓塞（各n=1）。因AE停用pumitamig者6例（14.0%）（20 mg/kg组2例；30 mg/kg组4例）。未发生治疗相关死亡。 结论： pumitamig联合依托泊苷/卡铂在1线ES-SCLC中展现出可观的疗效与可接受的安全性。作为首个在全球人群中报道的同时靶向免疫检查点抑制与抗血管生成的双特异性抗体研究，本结果与此前在中国1线SCLC研究中的积极数据相互印证。本次剂量优化研究支持在1线SCLC中进一步开发pumitamig；其Ⅲ期研究ROSETTA Lung-01正在开展中。 此外，在三阴乳腺癌等其他实体瘤领域，pumitamig的缩瘤效果明显，正显示出卓越的抗肿瘤疗效。 此外，在一众PD-1/VEGF双抗在研企业以外，也有新的企业开始布局PD-L1/VEGF双抗。进度仅次于pumitamig的是华海药业的HB0025。 02 华海药业丨PD‑L1/VEGF双抗 HB0025由华海药业子公司华奥泰自主研发，将VEGFR1受体的第二功能域融合到抗PD-L1单抗的重链上，构建出同时靶向PD-L1和VEGF的创新融合蛋白。这一构架使HB0025既能高特异性结合PD-L1和VEGF两个靶点，又能通过单一分子实现“增效减毒”——增强疗效的同时降低了联合用药的毒副作用。其作用机制与Pumitamig异曲同工：封堵PD-L1/PD-1信号恢复免疫监视，阻断VEGF抑制肿瘤新生血管并改善微环境，从而双线夹击肿瘤。 HB0025目前在多个瘤种推进II/III期临床，尤其在肺癌和妇科癌症领域进展迅速： 2025 CSCO 年会上，华奥泰生物（浙江华海药业子公司）将以1 场口头报告、1 个壁报：展示全球首创抗 PD-L1/VEGF 融合蛋白 HB0025 的最新临床进展和成果。 【口头报告】HB0025 联合化疗一线治疗晚期非小细胞肺癌（NSCLC）II 期研究，凭借优异的研究数据成功入选口头报告，将在此次会议上首次正式对外重磅发布针对鳞状NSCLC及非鳞状NSCLC的疗效与安全性数据。 【壁报展示】HB0025 联合化疗一线治疗晚期子宫内膜癌II期研究成功入选壁报展示，将在前期于ASCO 2025已发布数据的基础上，进一步更新并呈现最新的研究结果。  在2025年ASCO年会上公布的II期研究结果显示： ORR高达84.3%，DCR达到 100%。其中错配修复缺陷（dMMR）亚组ORR 100%，功能正常（pMMR）亚组ORR 85.4%，均优于帕博利珠单抗联合化疗（标准方案）的历史数据。随访中位5.7个月时，缓解持续时间和生存期尚未成熟，但6个月无进展生存率已高达 。安全性方面，任意级别治疗相关不良事件发生率 98.1%，≥3级占 59.3%，常见为血细胞减少等化疗相关反应；免疫相关不良反应发生率 25.9%，仅2例因不良反应停药，未见治疗相关死亡。基于如此卓越的缩瘤效果和可控安全性，HB0025一线治疗子宫内膜癌的III期确证试验计划已获监管受理，有望于年内启动。 近年来，子宫内膜癌的创新药进展明显提速： 子宫内膜癌的ADC时代到来丨映恩HER2 ADC、阿斯利康B7H4 ADC，加速三期布局 子宫内膜癌成为免疫竞逐新瘤种，PD-1/L1先后获批 华海药业能否复刻康方生物PD-1/CTLA-4双抗在宫颈癌领域的成功，率先依靠难治性妇科肿瘤获批上市，值得期待。 【03 华海药业HB0025的前景展望】 在PD-(L)1/VEGF双抗火热的BD浪潮中，华海药业的HB0025迄今尚未宣布大型跨国授权合作，未来获得BD的可能性大吗？我们具体来分析下： 1. 凭借数据实力赢得关注：  HB0025目前披露的子宫内膜癌临床数据已相当亮眼，即将在CSCO发布的NSCLC优异缓解率估计会进一步增加曝光量。一款新药能否出圈，归根结底靠硬核数据说话。华海可以通过高质量的临床发表和会议展示来提高HB0025的知名度和认可度。事实上，在PD-(L)1/VEGF双抗全球29款在研产品中（中国占21款），HB0025已是进展最快的PD-L1/VEGF品种之一。其成为全球第二个进入III期的同类产品这一定位，本身就是出圈的亮眼标签。这将为日后寻求合作奠定谈判筹码和口碑基础。 2. 国内先行上市以验证价值：  在无BD情况下，华海也可能选择先在中国完成关键临床并申报上市。凭借华海的产业化能力和本土资源，HB0025若能在国内率先获批一两个优势适应症（如子宫内膜癌一线或特定亚型NSCLC），可能刺激海外药企的兴趣。这种“国内先上市、海外再合作”的模式在近年来并不罕见。例如，荣昌生物的ADC维迪西妥单抗即是在国内获批后，才引来Seagen的大额合作。对于HB0025，特别是子宫内膜癌领域目前尚无同类双抗竞争者，如果能以突破性疗效拿下该适应症的NMPA批准，华海将在全球占据第一个PD-L1/VEGF双抗上市的先机。这无疑将极大提高其在国际市场的议价能力。因此，无BD并不意味着闭门造车，华海完全可以“两条腿走路”—一方面积极准备中国III期和申报，以成功上市证明自身实力；另一方面在过程中继续物色合适伙伴，等产品价值水涨船高时再谈合作也不迟。 3. 潜在合作伙伴及模式分析： 尽管尚未官宣BD，但坊间一直有跨国药企洽谈HB0025的传闻。尚未参与此赛道的大玩家如罗氏、AZ、艾伯维可能抛出橄榄枝。 艾伯维2025年H1财报与PD-(L)1×VEGF双抗战略分析 华海需考虑的，是选择何种合作模式最优：是区域授权（如仅授予除中国外权利），还是全球合作开发（共同承担费用，共享利润），抑或干脆寻求海外许可（license-out）将项目完全转让？每种模式都有利弊。如果华海资金和团队实力足够，倾向共同开发以保留更多权益；反之，license-out 虽一次性收益高但未来分成低。基于目前国内药企出海惯例，前期license-out获取可观首付款支持研发是主流选择。但鉴于华海自身也是上市公司且现金流充裕，不排除其大胆尝试自主出海。例如，他们已在美国开展临床，如能在欧美组建小型团队推进开发，未来直接面对FDA申报也并非不可能。不过这条路风险和难度极高，需要强大的临床开发、注册和市场能力支撑，大多数中国公司最终还是会引入当地伙伴。因此，更现实的推测是：华海当前先专注把Phase II/III数据做扎实，一旦某个试验结果达到里程碑（比如NSCLC III期显著优于标准疗法），就会是BD最佳窗口期。届时，谈判筹码和公司估值都达到峰值，再谈合作能获取最大收益。 4. 差异化定位与海外竞争： 如果HB0025寻求出海，还需考虑如何在众多竞争药物中脱颖而出。优势之一是其PD-L1/VEGF“双特异性融合蛋白”的独特形式，与主流PD-1/VEGF抗体有所区分。这种分子可能在机制上更偏向于直接作用肿瘤细胞及微环境，可以作为PD-1/VEGF路径的补充选择，避免正面交锋。同样，在适应症选择上，HB0025可以错位竞争：例如在妇科肿瘤（子宫内膜癌、卵巢癌）领域率先突围，形成差异化优势，而不必一开始就在肺癌大战群雄。等在某些细分领域站稳脚跟，再逐步扩展到高竞争领域。同时，华海作为老牌制药企业，质量体系和生产能力过硬，完全有实力按照国际标准供应产品，这也是海外伙伴看重的一点。没有现成BD也给了华海灵活调整战略的空间：可根据临床结果优化适应症布局，不受先前合作条款掣肘。例如看到哪种癌种数据好，就重点投入冲击该领域的一线治疗，从而打造“best-in-class”形象，提高海外认可度。 根据目前多款PD-(L)1/VEGF双抗的交易，对于HB0025，如果成功实现BD，普遍假设 10–12 亿美元首付、总交易 50–60 亿美元区间，较当前市值具备显著重估空间。创新药研发费用同比大增，是利润短期承压的主因；若 HB0025 交易落地，首付款有望一次性覆盖未来 3–4 年研发投入，并带来正向经营现金流。 当然，风险性还是很大的。主要风险就在于 III 期数据是否可重复 II 期疗效，以及全球子宫内膜癌注册路径的法规不确定性。还有最大的风险性就是ORR不一定转化为OS获益。 早在今年的5月份，Summit公布的全球III期HARMONi试验数据显示，ivonescimab联合化疗组相比对照组PFS风险比（HR）为0.52（95%CI：0.41–0.66，p<0.00001），具有统计学显著意义；而OS的HR为0.79（95%CI：0.62–1.01，p=0.057），虽呈现阳性趋势但未达到统计学显著。值得注意的是，亚裔与欧美患者均出现了PFS获益，两大人群的疗效一致。这种亚/欧美群体疗效一致性也与HARMONi-A中国单区研究的结果相符：HARMONi-A一期中ivonescimab对照化疗组的PFS HR约为0.46，OS HR约为0.80（均未达显著）。这一系列数据显示，在既往一线EGFR-TKI耐药的NSCLC患者中，ivonescimab显著延长了PFS，但OS终点尚待数据成熟验证。 在HARMONi数据公布后，投资者普遍以OS终点为关键预期指标，Summit股价随之大幅下挫。该消息公布当日Summit股价下跌约26%，这已是近两个月内的第二次大跌。此前4月，合作方康方生物发布的相关研究OS数据中期失败也曾令Summit暴跌36%。市场担忧OS未达标将严重影响FDA批准预期，因而在数据公布后出现抛售。 在美国审批方面，FDA历来对晚期NSCLC终点要求严格，通常以OS改善作为金标准。然而，在EGFR-TKI耐药的NSCLC中，尚无其他方案能显著延长OS。这也是依沃西单抗能够获批的潜在支撑证据，但近期FDA日趋严苛的批药政策，则大概率是市场恐慌抛售的原因所在吧。 04 FDA监管新动向：OS重要性提升 在免疫治疗进入成熟期后，监管机构对临床终点的要求日趋严格。美国FDA最新指导原则明确指出：在肿瘤临床试验中即使以无进展生存（PFS）或客观缓解率（ORR）等替代终点作为主要指标，仍应系统收集和提交总生存期（OS）数据。 这一指导反映了监管层对后期疗效验证的重视，背后有多重原因： 生存终点最具临床意义： OS直接衡量患者是否真正延长寿命，是评估抗癌疗效的黄金标准。相比之下，ORR和PFS虽能较早反映药物活性，但可能受后线治疗、交叉救治等影响，并非总能转化为生存获益。近年来一些免疫疗法出现“PFS改善但OS未延长”的情况，引发监管对过度依赖替代终点的担忧。FDA肿瘤中心在2023年就曾组织系列研讨会，探讨早期终点与OS相关性的复杂性。因此，对于旨在成为“一线新标准”的双抗疗法而言，证明OS优势几乎成为必须跨越的门槛。 加速审批的确认需求： 在免疫治疗初期，不少药物通过ORR/PFS获得加速批准，但后续确证试验中未能验证OS获益，最终被撤回适应症（如某些PD-1单抗在肝癌二线等领域）。FDA最新加速审批指南强调，应尽早开展确证性试验并优先选择OS等硬终点。免疫双抗作为新兴疗法，如果仅依赖中期缓解数据获批，未来仍需以OS证实价值，否则将面临市场认可度和付费意愿的挑战。因此企业在设计III期试验时，往往将OS作为主要或关键次要终点，并与FDA预先沟通终点设置，以确保符合后期审评要求。 安全因素考量： FDA指出，OS不仅是疗效指标，也是重要的安全指标。某些新疗法提高了缓解率，却可能伴随累积毒性导致晚期生存受损。如果没有OS数据，很难全面权衡风险收益。特别是IO疗法常出现延迟或持久性副作用，更需长期随访观察。因此监管要求提供OS数据，也是为了确保患者长期获益大于风险，避免“饮鸩止渴”式的无效治疗。 总而言之，OS愈发关键的审评取向对PD-(L)1/VEGF双抗既是压力也是动力。一方面，它督促厂商不能仅以短期数据论英雄，必须脚踏实地证明病人生存获益；另一方面，如果双抗类能在OS上击败既往标准，那将成为撬动临床格局的有力证据。PD-L1/VEGF双抗聚焦肿瘤微环境的独特机制，是否真能转化为更优的长期疗效？答案有望在不久的将来由III期试验来揭晓。在此之前，业界应保持审慎乐观，既要肯定当前令人鼓舞的中期结果，又要以最终改善病人生存为最高目标。 ★

PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/BMS986545) plus chemotherapy continues to show encouraging antitumor activity in patients with extensive-stage small cell lung cancer (”ES-SCLC”), expanding evidence for its potential to set a new standard of care in first-line ES-SCLC and beyond Global interim Phase 2 data showed a 76.3% confirmed objective response rate (cORR), 100% disease control rate (DCR), a median progression free survival (mPFS) of 6.8 months and a manageable safety profile Data confirm dose selection for the ongoing global pivotal Phase 3 ROSETTA LUNG-01 trial September 8, 2025 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today presented interim data from a global randomized Phase 2 trial (NCT06449209) evaluating pumitamig (also known as BNT327 or BMS986545), an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer (“ES-SCLC”). The data, which are consistent with data presented at the European Lung Cancer Congress (“ELCC”) 2025 from a Phase 2 trial conducted in China (NCT05844150), showed encouraging anti-tumor responses with a positive trend in the secondary endpoint progression free survival. Pumitamig plus chemotherapy demonstrated a manageable safety profile with no new safety signals and a low discontinuation rate. The data are being presented today as a late-breaker oral presentation at the IASLC 2025 World Conference on Lung Cancer (“WCLC”) hosted by the International Association for the Study of Lung Cancer in Barcelona. “Small cell lung cancer is the most aggressive type of lung cancer with rapid growth, a poor prognosis and 5-year relative survival rate of just 5% in advanced stages.1,2,3 While approximately 60-70% of patients initially respond to current standard of care treatments, most progress within months after treatment signifying an urgent need for new treatment options which improve outcomes,” said John V. Heymach, M.D., Lead Investigator and Chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. “The response rate and early progression free survival we are seeing in this interim analysis are encouraging and merit further investigation in a larger trial to validate pumitamig’s potential to offer patients more durable anti-tumor responses relative to current standard of care.” The interim analysis included 43 patients with untreated extensive-stage small cell lung cancer (Cohort 1) who received pumitamig in combination with standard of care chemotherapy in two dose levels. At the August 7, 2025 data cut-off, among 38 efficacy-evaluable patients, the confirmed overall response rate was 76.3% (85.0% at 20 mg/kg [dose level 1] and 66.7% at 30 mg/kg [dose level 2]) and the disease control rate (DCR) was 100%. The mean best percentage change in tumor size showed a tumor shrinkage of 56.7% with 89.5% of patients achieving early tumor shrinkage. Median progression-free survival (mPFS) was 6.8 months (6.3 months at 20 mg/kg and 7.0 months at 30 mg/kg), with mOS not being mature at the time of the analysis. Pumitamig plus chemotherapy showed a manageable safety profile, with no new safety signals beyond those typically described for chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies, and a discontinuation rate of 14%. Out of 43 patients, pumitamig-related treatment-emergent adverse events of Grade ≥3 were reported in 1 patient at dose level 1 and five patients at dose level 2. “Every innovation we pursue starts with the needs of patients. These interim data for pumitamig presented today show encouraging signals for our science-driven approach to address two fundamental drivers of small cell lung cancer in one single molecule,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “Our ultimate goal is to translate science into meaningful survival benefits for many patients by overcoming some of the biggest treatment challenges, not only in small cell lung cancer but also across other difficult-to-treat solid tumors. These interim data for pumitamig represent an important step in the right direction.” “Today’s data add to the growing body of evidence indicating the potential of pumitamig to improve outcomes across a wide range of solid tumors,” said Bryan Campbell, Senior Vice President, Head of Program Leadership, Hematology, Oncology, Cell Therapy at Bristol Myers Squibb. “These are the first-ever data in a global population in advanced small cell lung cancer for a PD-(L)1 x VEGF bispecific antibody, supporting a possible new standard of care for patients with extensive-stage small cell lung cancer. We look forward to continuing to jointly advance research and development of pumitamig as a potential new treatment option with meaningful clinical benefit for patients in need.” A global randomized Phase 3 trial, ROSETTA-LUNG-01 (NCT06712355), evaluating pumitamig plus chemotherapy versus atezolizumab plus chemotherapy as a first-line treatment in patients with untreated ES-SCLC is ongoing. The pivotal trial is enrolling patients at clinical trial sites in the United States, the United Kingdom, Türkiye, China, the Republic of Korea, and Australia with additional sites planned to open globally. Pumitamig received Orphan Drug designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with small cell lung cancer in 2025. The full abstract is available on the WCLC website. Click here for further information on BioNTech’s pipeline assets. The global randomized, open-label, parallel group Phase 2 clinical trial (BNT327-01; NCT06449209) evaluated pumitamig (BNT327/BMS986545) in patients with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) who progressed on first- or second-line treatment (Cohort 2 and Cohort 3). In Cohort 1, patients received pumitamig in two dose levels + chemotherapy (etoposide+carboplatin) for four cycles, followed by pumitamig maintenance for up to 2 years or until disease progression or unacceptable toxicity to identify an optimized dose for future clinical investigation. Cohort 2 and Cohort 3 explored the combination of two dose levels of pumitamig plus paclitaxel, or topotecan in the second- or third-line setting. The co-primary endpoints of the trial were per RECIST 1.1 objective response rate (ORR), change in tumor size and early tumor shrinkage, and safety per NCI CTCAE v5.0. Secondary endpoints include duration of response (DoR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS). Small cell lung cancer (SCLC) accounts for 15% of all lung cancer cases, with an estimated 250,000 new cases globally per year.1 It is the most aggressive type of lung cancer often spreading early to other parts of the body and developing resistance mechanisms which makes it more challenging to treat.1,2 Platinum-based chemotherapy combined with etoposide chemotherapy has been the standard first-line treatment for decades. While the addition of immune checkpoint inhibitors to chemotherapy has shown improved survival outcomes for patients with advanced or extensive-stage disease, most patients progress within months after treatment, and the prognosis remains poor. The 5-year survival rate for patients with extensive-stage SCLC is only 5%, emphasizing the need for new treatment options that extend progression-free survival.2, 3 Pumitamig is a novel investigational bispecific antibody, jointly developed by BioNTech and BMS, combining two complementary, validated mechanisms in oncology into one single molecule. Pumitamig combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. The blocking of VEGF-A is aimed at reversing the tumor’s immuno-suppressive effect in its microenvironment and cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), with the intention of preventing the tumor from growing and proliferating. Pumitamig may be differentiated via its mechanism of action of targeting PD-L1 on tumor cells to localize anti-VEGF activity within the tumor microenvironment, aiming to enhance therapeutic precision and minimize systemic exposure. More than 1,200 patients have been treated with pumitamig in clinical trials to date. More than 20 clinical trials are currently ongoing or planned to evaluate pumitamig either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in more than 10 solid tumor indications. Multiple global trials are ongoing or planned to start in 2025, including three global clinical trials with registrational potential evaluating pumitamig plus chemotherapy compared to standard of care treatments in first-line small cell lung cancer (ROSETTA LUNG-01; NCT06712355), first-line non-small cell lung cancer (ROSETTA LUNG-02; NCT06712316) and first-line triple-negative breast cancer (ROSETTA BREAST-01). Additional trials are ongoing exploring novel treatment combinations of pumitamig, including combinations with BioNTech’s proprietary antibody-drug conjugate candidates (“ADCs”) or immunomodulator candidates. Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. 1 Rudin CM, Brambilla E, Faivre-Finn C, Sage J. Small-cell lung cancer. Nat Rev Dis Primers. 2021 Jan 14;7(1):3. doi: 10.1038/s41572-020-00235-0. PMID: 33446664; PMCID: PMC8177722. 2 Yılmaz, F., Yaşar, S., Tatar, Ö.D. et al. Prognostic value of the StAN score in elderly small cell lung cancer. Sci Rep 15, 23495 (2025). https://doi.org/10.1038/s41598-025-08115-x 3 Byers LA, Rudin CM. Cancer. 2014 Oct 21;121(5):664–672. The content above comes from the network. if any infringement, please contact us to modify.