Sacituzumab tirumotecan

The EGFR-NSCLC pipeline possesses some drugs in late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Zipalertinib (CLN-081) (Cullinan Oncology/Taiho Pharma), Firmonertinib (ArriVent BioPharma), Ivonescimab (SMT112) (Akeso Biopharma/Summit Therapeutics), PF-08046054 (Pfizer), Patritumab Deruxtecan (Daiichi Sankyo/AstraZeneca), Sacituzumab Tirumotecan (MK-2870) (Merck/Kelun-Biotech), SYS6010 (CSPC Pharmaceutical), and JMT101 (Shanghai JMT-Bio). The expected launch of these therapies shall further create a positive impact on the market. LAS VEGAS, June 1, 2026 /PRNewswire/ -- Non-small cell lung cancer is increasingly evolving into a biomarker-driven market, with EGFR-mutated disease emerging as one of the most commercially significant segments. The space is dominated by blockbuster EGFR-targeted therapies such as TAGRISSO, which now generates nearly USD 6 billion annually, reinforcing the importance of precision medicine in NSCLC management. The treatment landscape has rapidly expanded beyond tyrosine kinase inhibitors (TKIs), particularly as resistance mutations continue to rise following the widespread first-line adoption of TAGRISSO. Consequently, the post-TAGRISSO setting has become one of the largest unmet needs in EGFR NSCLC, driving intense interest in next-generation therapeutic approaches capable of overcoming resistance and extending survival outcomes. Among these emerging modalities, antibody-drug conjugates (ADCs) are gaining considerable momentum. Following the approval of Datroway, several late-stage ADC candidates are advancing through pivotal studies, including izalontamab brengitecan from Bristol Myers Squibb, telisotuzumab adizutecan from AbbVie, and sacituzumab tirumotecan from Merck. These programs highlight the growing industry focus on ADC innovation within EGFR-driven NSCLC. Sadaf Javed, an oncology expert, said that the market is witnessing a convergence of multiple advanced therapeutic platforms, including TKIs, ADCs, bispecific antibodies, CDACs, and gene therapy-based combinations. This expanding competitive landscape suggests that future market leadership will depend heavily on differentiation across efficacy, resistance mutation coverage, administration convenience, safety, and combination potential. While exon 20 insertion mutations have attracted substantial attention in recent years and transformed into a highly competitive segment, uncommon and atypical EGFR mutations, including G719X, S768I, and PACC mutations, are emerging as the next frontier in EGFR NSCLC research and drug development, creating additional opportunities for targeted innovation. Discover who will dominate EGFR NSCLC after osimertinib @ Reflecting the strong commercial and clinical momentum in this space, DelveInsight estimates that the EGFR NSCLC market across the 7MM, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 6.6 billion in 2025. Below, we highlight 8 late-stage EGFR NSCLC therapies poised to reshape the future of EGFR NSCLC management. Akeso Bio and Summit Therapeutics' Ivonescimab Bispecific antibody Akeso's ivonescimab (AK112, SMT112) is a first-in-class PD-1/VEGF bispecific antibody and the first candidate in this category to advance into Phase III clinical trials. Developed using the company's proprietary Tetrabody platform, the therapy is designed to simultaneously inhibit PD-1 interactions with PD-L1 and PD-L2 while also preventing VEGF from binding to its receptors. The combination of PD-1 inhibition and VEGF blockade has already demonstrated strong clinical benefit across several tumor types, including NSCLC, renal cell carcinoma, and hepatocellular carcinoma. By integrating both mechanisms into a single molecule, ivonescimab may provide more efficient dual-pathway suppression and potentially deliver stronger antitumor activity than conventional combination regimens. The FDA has accepted for filing Summit Therapeutics' Biologics License Application based on results from the Phase III HARMONi trial, with a PDUFA target action date set for November 14, 2026. As per Javed, ivonescimab has already made notable regulatory progress in China, reinforcing confidence in the therapy and supporting its broader international expansion strategy. Furthermore, ongoing regulatory reviews and submissions across major markets suggest the drug could establish a presence in the global immunotherapy landscape in the near future. Partnerships with pharmaceutical companies exploring combination approaches involving targeted therapies and antibody-drug conjugates may also broaden its therapeutic applications and commercial potential. ArriVent BioPharma and Shanghai Allist Pharmaceuticals' Firmonertinib Small molecule Firmonertinib (previously known as furmonertinib) is an orally administered, mutation-selective EGFR inhibitor characterized by strong brain penetration and broad activity against both common and uncommon EGFR alterations, including PACC and Exon 20 insertion mutations. The therapy is currently under evaluation in a global Phase III study, FURVENT (NCT05607550), for first-line NSCLC patients harboring EGFR Exon 20 insertion mutations, as well as in the global Phase Ib FURTHER trial (NCT05364043), which is assessing its efficacy in patients with EGFR PACC mutations. Additionally, firmonertinib is being investigated in combination regimens for advanced or metastatic NSCLC patients with classical EGFR mutations through a collaboration with InnoCare Pharma. Firmonertinib is emerging as a promising targeted therapy with the potential to enhance the treatment landscape for EGFR-mutant NSCLC, especially in patients with rare EGFR alterations and CNS involvement, according to Aparna Thakur, Assistant Project Manager, Forecasting at DelveInsight. Should ongoing global studies continue to deliver encouraging efficacy and safety data, the drug may establish itself as a strong contender within the EGFR TKI market while broadening therapeutic options for patients with uncommon EGFR mutations. Explore best emerging therapies post-TAGRISSO @ Emerging Therapies in EGFR NSCLC Market Merck and Kelun-Biotech's Sacituzumab tirumotecan ADC Sacituzumab tirumotecan is an investigational antibody-drug conjugate (ADC) composed of three key elements: sacituzumab, a monoclonal antibody directed against TROP2; a cytotoxic payload belonging to the topoisomerase I inhibitor class; and an innovative irreversible yet hydrolyzable linker that connects the antibody to the payload using proprietary conjugation technology. The therapy was developed by Kelun-Biotech, a holding subsidiary of Kelun Pharmaceutical, which specializes in the research, development, manufacturing, commercialization, and global partnering of innovative biologics and small-molecule therapies. Through a collaboration agreement, Kelun-Biotech granted Merck exclusive rights to develop, manufacture, and commercialize sacituzumab tirumotecan outside Greater China. Pfizer's PF-08046054 ADC Pfizer's PF-08046054 (PDL1V) is an experimental antibody-drug conjugate designed to target PD-L1–expressing cells by delivering the potent cytotoxic payload monomethyl auristatin E (MMAE). Beyond its direct cell-killing mechanism, PDL1V also demonstrates antitumor effects through bystander activity and the induction of immunogenic cell death. To know more about best ADCs in EGFR NSCLC, visit @ EGFR NSCLC Medication Cullinan Therapeutics and Taiho Pharma's Zipalertinib Small molecule Zipalertinib is a next-generation, orally available, irreversible EGFR inhibitor designed to selectively and strongly inhibit tumor cells harboring EGFR Exon 20 insertion mutations. Preclinical studies suggest that it largely spares wild-type EGFR-expressing cells, potentially reducing the toxicities commonly linked to wild-type EGFR inhibition. Thakur anticipated that zipalertinib will play a notable role in the EGFR Exon 20ins segment as a next-gen, mutant-selective TKI, especially given its oral dosing, CNS activity, and breakthrough therapy designation by the FDA. Future performance will be shaped by outcomes from ongoing Phase III (REZILIENT3) studies assessing zipalertinib plus platinum-pemetrexed chemotherapy versus standard care. CSPC Pharmaceutical's SYS6010 ADC SYS6010 is a novel antibody-drug conjugate (ADC) that combines a humanized anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody with the topoisomerase I inhibitor JS-1 through a cleavable glycine-glycine-phenylalanine-glycine tetrapeptide linker. As per company's Q2 presentation, SYS6010 is currently under evaluation in a Phase III study for first- and second-line EGFR-mutated NSCLC. The presentation also noted that, in third-line and later EGFR-mutant NSCLC, the company is preparing a trial that will compare SYS6010 against chemotherapy. In 2L+ EGFR-wildtype NSCLC, a separate comparative trial against chemotherapy is also in the preparation phase. Find out more about top EGFR NSCLC ADC pipeline assets @ EGFR NSCLC Clinical Trials Source: EGFR NSCLC Market Report EGFR NSCLC Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key EGFR NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hansoh Pharmaceutical, Johnson & Johnson Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Akeso Biopharma, Summit Therapeutics, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

//   • 依沃西+化疗显著降低患者死亡风险达34%，击败晚期鳞状NSCLC“PD-1抑制剂+化疗”一线标准方案； • 贝莫苏拜单抗+安罗替尼+化疗，为一线非鳞状NSCLC患者提供治疗新选择； • 芦康沙妥珠单抗+K药，一线治疗显著改善PD-L1阳性晚期NSCLC患者的mPFS。 2026年美国临床肿瘤学会（ASCO）年会正火热进行，围绕非小细胞肺癌（NSCLC）一线治疗的竞争正持续升温，多项与标准治疗头对头的试验结果陆续揭晓。 其中，康方生物的PD-1/VEGF双抗和正大天晴的“得福组合”（抗PD-L1单抗+TKI），分别在鳞状和非鳞状NSCLC一线治疗中，头对头战胜PD-1联合化疗；科伦博泰的TROP2 ADC芦康沙妥珠单抗则在PD-L1阳性晚期NSCLC一线治疗中，联合K药对比K药单药显著改善PFS。 PD-1/VEGF双抗与国产PD-1的对决 作为全球首个在III期头对头临床研究中证明疗效显著优于K药的药物，依沃西单抗的高光时刻还在继续。 这一次，依沃西+化疗与替雷利珠单抗+化疗的头对头III期HARMONi-6研究，成为ASCO成立61年以来，首个登陆大会Plenary Session的中国原创新药研究成果。 此前公布的无进展生存期（PFS）数据显示，依沃西联合化疗组的中位PFS长达11.14个月，较对照组的6.90个月显著提升，可降低40%的疾病进展或死亡风险（HR=0.60）。 这种PFS获益能否转化为更长远的总生存期（OS）获益？这正是此次ASCO年会上要回答的关键问题。 结果不负众望。依沃西联合化疗mOS为27.9个月，相比对照组延长了4.2个月。该联合疗法还将显著降低患者死亡风险达34%，风险比(HR)=0.66，成为首个在既往未经治疗的晚期鳞状NSCLC患者中，击败“PD-1抑制剂联合化疗”这一现有标准方案的疗法。 来源|雪球 34%的改善幅度超出了许多业内人士的预期。根据《柳叶刀》此前发表的文章，针对HARMONi-6研究中OS中期分析的预设成功临界值为HR=0.722，而知名投行Leerink Partners测算的HR大约在0.83~0.87之间，一些乐观的投资者则预计该数字在0.65到0.7之间。 此番数据公布之前，也有人怀疑HARMONi-6能否达到统计学显著性。最终p值为0.0017，达到了预先设定的0.0049的统计学显著性界值。 HARMONi-6研究的主要研究者陆舜教授表示：“依沃西这一研究成果，以硬核的III期头对头临床研究数据，重新定义了sq-NSCLC（鳞状非小细胞肺癌）一线治疗的金标准，确立了临床获益的新标杆，这是中国创新推动全球肿瘤治疗水平提升的一个里程碑。” 尽管取得OS和PFS双显著阳性结果，但也不乏对这些数据提出质疑的人，HARMONi-6研究的ASCO特邀评论员、约翰霍普金斯大学Sidney Kimmel综合癌症中心胸部肿瘤学项目主任Julie Brahmer博士就是其中一位。 据FiercePharma报道，Brahmer批判性地指出现有数据的多重局限：中位随访不足两年且短于两组中位OS，而VEGF抑制剂历史上早期OS阳性信号往往会在后期消失；安全性方面，尽管出血风险较低，但试验组在VEGF相关不良事件上与历史上单独抗VEGF的药物相比无显著差异；在入选标准上还存在性别失衡（几乎全为男性）、年龄限制（排除75岁以上患者）、以及出血风险纳入标准模糊等问题。 这些不足让Brahmer质疑HARMONi-6的OS研究结果对全球人群的适用性，并认为还需要更多研究以进一步验证。 拓展阅读 死亡风险降低34%！康方生物依沃西头对头战胜PD-1 PD-L1+TKI+化疗的胜利 向替雷利珠单抗联合化疗发起挑战并成功的，还有正大天晴的“得福组合”——贝莫苏拜单抗（抗PD-L1单抗）联合安罗替尼（TKI）。 与依沃西攻克的对象是鳞状非小细胞肺癌不同，此次“得福组合”瞄准的是非鳞状非小细胞肺癌（nsq-NSCLC）。这也是全球首个成功挑战免疫检查点抑制剂联合化疗一线治疗nsq-NSCLC的Ⅲ期临床研究，并入选了此次ASCO重磅摘要（LBA）。 结果显示，试验组中位PFS达到14.42个月，较对照组提升6.08个月，疾病进展或死亡风险降低33%（HR=0.67）；几乎所有亚组均可从“得福组合”方案中获益，尤其PD-L1 TPS＜1%人群的中位PFS为12.45个月（vs 6.54个月），疾病进展/死亡风险降低39%（HR=0.61）。 来源|正大天晴官网 目前，nsq-NSCLC的标准治疗方案为免疫检查点抑制剂联合含铂化疗，但其PFS仅8~9个月，长期获益有限。 此次最新披露的结果表明，贝莫苏拜单抗联合含铂化疗序贯贝莫苏拜单抗联合安罗替尼，有望为全球nsq-NSCLC患者提供一种安全有效的治疗新选择。 这并非“得福组合”首次在NSCLC一线治疗中取得胜利。 此前，该组合已在鳞状NSCLC中头对头战胜了替雷利珠联合化疗。在TQB2450-Ⅲ-12研究中，“得福组合”取得10.12个月的mPFS（对照组为7.79个月），疾病进展或死亡风险降低36%。 而在PD-L1阳性NSCLC中，该组合头对头战胜了K药。在CAMPASS研究中，“得福组合”中位PFS达到11.0个月，较K药治疗提升3.9个月，疾病进展或死亡风险降低30%，经确认的ORR为57.3%（vs 39.5%），疾病控制率（DCR）为85.9%（vs 79.1%）。 目前，“得福组合”治疗广泛期小细胞肺癌、子宫内膜癌、一线肾细胞癌、腺泡状软组织肉瘤（ASPS）等适应症已在中国获批，针对晚期鳞状NSCLC一线治疗、Ⅲ期不可切除NSCLC患者的巩固治疗上市申请均已受理，另有多个适应症研究正在进行中。 “ADC+K药”与K药的对垒 在PD-L1阳性NSCLC一线治疗中，标准治疗（IO单药或IO+化疗）仍面临效率有限和原发耐药的挑战。 而此次在ASCO口头展示的OptiTROP-Lung05研究结果，可能重新定义这类人群的治疗格局。这也是首个在PD-L1阳性晚期NSCLC一线治疗中，证明ADC联合K药对比K药可显著改善PFS的III期临床研究。 结果显示，芦康沙妥珠单抗（sac-TMT）联合K药治疗组的mPFS，对比K药单药组（mPFS为5.7个月），显现出良好的获益趋势（HR=0.35）——虽尚未达到，但预测有望达到16.7个月（传统IO联合化疗一线治疗的mPFS普遍仅维持在8.8~11.3个月）。 来源|科伦博泰官网 经BICR评估的联合组ORR突破70.2%（vs 42.0%），OS数据尚未成熟（NR vs 14.5个月）但已呈现获益趋势（HR=0.55），12个月OS率为80.4%（vs 68.9%）；预设亚组获益一致，PD-L1 TPS 1%~49%和TPS≥50%患者PFS的HR值分别为0.28和0.47，非鳞癌和鳞癌患者PFS的HR值分别为0.28和0.44。 与阿斯利康/第一三共的TROP2 ADC药物Datroway（Dato-DXd）相比，sac-TMT的数据颇有竞争力。在I期Tropion-Lung02研究中，无论PD-L1表达水平如何，在42例一线NSCLC患者中，Datroway联合K药的ORR为54.8%，mPFS为11.2个月。 “OptiTROP-Lung05研究取得了令人欣慰的数据，这不仅是一次成功的探索，更是对驱动基因阴性晚期肺癌治疗格局的重塑，标志着我们正从免疫时代迈向ADC+IO精准协同的新纪元。”领衔该研究的周彩存教授公开点评。 在他看来，这项研究“称得上是划时代、改变临床格局的重磅研究”，充分印证了TROP2 ADC联合IO一线治疗模式的稳健性和长期临床价值。 不过Leerink Partners分析师在报告中指出：“在取代一种IO标准治疗时，我们认为治疗持续时间、应答持续时间以及总生存期是更重要的结局。” 目前，OptiTROP‑Lung05研究成果已同步刊登《柳叶刀》，sac-TMT联合K药一线治疗PD-L1 TPS≥1%的EGFR基因突变阴性和ALK阴性的局部晚期或转移性NSCLC的上市申请也已递交CDE并被纳入优先审评。 在海外，合作伙伴默沙东对于sac-TMT同样寄予厚望。除了在一线PD-L1高表达NSCLC中开展其联合K药与K药头对头的III期研究，默沙东还另外开展了16项单药或联合用药的全球性III期临床。 2025ASCO报道回顾 亚盛医药：从纳斯达克IPO到8次亮相ASCO 大涨17.64%！连涨五日！谁是赢家？ 挑战奥希替尼耐药，中国Biotech谁先夺魁？ 小细胞肺癌治疗将迎来重大变革 编辑 | 姚嘉 yao.jia@PharmaDJ.com 总第2936期 访问研发客网站www.PharmaDJ.com 深度报道和每日新闻抢鲜看