Dubodencel

NEWS 肿瘤用药周报 2026年第32周（8月3日-8月9日）数据来源：NMPA、FDA公开信息  |  整理：新唯医学编辑部 本周重点关注 恒瑞瑞康曲妥珠单抗（艾维达®）结直肠癌适应症获批，成为国内首个获批该适应症的HER2 ADC，集齐肺癌、乳腺癌、结直肠癌三大高发实体瘤。 药捷安康替恩戈替尼片获批胆管癌适应症，成为首款FGFR靶向1类新药，报产至获批仅9个月。 FDA加速批准首款溶瘤病毒免疫疗法Tudriqev，为PD-1治疗失败的晚期黑色素瘤患者提供新选择。 诺华Pluvicto（¹⁷⁷Lu-PSMA）前移至激素敏感性前列腺癌，eligible患者群体近翻倍。 礼来新一代KRAS G12C抑制剂Olomorasib获胰腺癌突破性疗法认定。 CSCO结直肠癌诊疗指南（2026版）重大更新，精准分型治疗体系全面升级。 NMPA获批动态 本周国家药监局（NMPA）共批准5项肿瘤相关药物动态，涵盖2项新获批/新适应症和3项申报上市。 日期 药物名称 适应症 类型 8月6日 替恩戈替尼片（药捷安康） 晚期/转移性/不可手术切除胆管癌（既往≥1线系统治疗+FGFR抑制剂治疗失败） 1类新药获批 8月6日 瑞康曲妥珠单抗/艾维达®（恒瑞医药） 经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的HER2阳性结直肠癌 新适应症获批（第3项） 8月4日 安尼妥单抗（石药集团/康宁杰瑞） HER2阳性乳腺癌（一线+新辅助） NDA申报受理 重点解读：替恩戈替尼片是首款获批的FGFR靶向1类新药，用于胆管癌后线治疗，从报产到获批不足9个月。瑞康曲妥珠单抗（艾维达®）成为国内首个获批结直肠癌适应症的HER2 ADC，基于III期HORIZON-CRC01研究：中位PFS 5.5个月 vs 2.8个月（HR=0.33），ORR 40.7% vs 4.5%，已被CSCO结直肠癌诊疗指南（2026版）推荐用于HER2阳性肠癌后线治疗。安尼妥单抗为国产首个获批的HER2双抗，乳腺癌一线及新辅助全病程布局。 FDA获批动态 本周美国FDA共批准/认定5项肿瘤相关药物动态，涵盖1项加速批准、1项适应症扩展和3项重要进展。 日期 药物名称 适应症/进展 类型 8月6日 Tudriqev（Replimune） PD-1治疗后进展的不可切除晚期皮肤黑色素瘤（联合纳武利尤单抗） 加速批准 7月31日 Pluvicto/¹⁷⁷Lu-PSMA（诺华） PSMA阳性转移性激素敏感性前列腺癌（联合ARPI） 适应症扩展 8月6日 Olomorasib/LY3537982（礼来） 经治KRAS G12C突变晚期胰腺癌 突破性疗法认定 8月7日 BI-1808（BioInvent） 铂耐药卵巢癌（联合帕博利珠单抗） 快速通道资格 8月7日 Sonesitatug vedotin（阿斯利康） 晚期胃癌二线及后线（CLARITY-Gastric01 III期成功） III期研究成功 重点解读：Tudriqev（vusolimogene oderparepvec）是基于HSV-1改造的溶瘤病毒免疫疗法，联合PD-1用于抗PD-1治疗失败的晚期黑色素瘤，IGNYTE研究显示ORR 24.2%，中位缓解持续时间14.1个月。Pluvicto联合ARPI将¹⁷⁷Lu-PSMA靶向放射配体疗法前移至激素敏感性阶段， eligible患者群体近翻倍。Olomorasib为新一代KRAS G12C抑制剂，1/2期LOXO-RAS-20001研究在胰腺癌中显示积极结果。BI-1808为首个抗TNFR2单抗，联合PD-1在铂耐药卵巢癌中ORR达24%，DCR 56%。Sonesitatug vedotin靶向CLDN18.2的ADC在晚期胃癌III期研究中显著延长OS，约60%胃癌患者表达该靶点。 重要研发进展 KRAS泛突变降解剂：Arvinas公司口服PROTAC泛KRAS降解剂公布临床前数据，可降解G12C/G12D/G12V/G12R等多种突变蛋白，DC50约3.6nM，最大降解幅度100%，联合PD-1后肿瘤免疫微环境改善。 TIL细胞疗法：LN-145治疗晚期NSCLC的IOV-LUN-202研究显示ORR 25.6%，DCR 71.8%，2例完全缓解，一次性回输即可长效控瘤。 个体化肿瘤疫苗：Diakonos Oncology的DOC1021个体化树突状细胞疫苗完成首批给药，针对PD-1治疗失败的晚期黑色素瘤，利用患者自身肿瘤组织制备，无需基因改造。 脑胶质瘤新突破：耐药免疫疗法（DRI）通过向脑内注射基因改造的γδT细胞，使新诊断胶质母细胞瘤患者中位PFS从8个月翻倍至16.1个月（JCO发表）。 新唯医学 · 医学信息部 ⚠️ 免责声明： 本文仅供医学信息参考，不构成任何用药建议。具体治疗方案请遵医嘱，在专业医生指导下进行。 关于新唯医学 新唯医学成立于2016年，旗下拥有新唯基因研发中心、新唯医学检验实验室及上海新唯生物科技有限公司。聚焦国家级高新技术企业，专注于打造临床分子病理检测服务推广、IVD试剂盒研发和生产、IVD检测仪器研发和生产，三位一体的发展格局，同时形成产、学、研、用高科技成果转化平台，依托安德森癌症中心、霍普金斯医学院、范德堡大学分子病理、中国科学技术大学、安徽医科大学等的学术与技术支持，秉承产学研一体化优势，研发和生产IVD系列产品，通过独立医学实验室为全球医药研发及各类医疗机构提供各种医学检验服务。 新唯医学检验实验室是国内早期开展液态活检的基因检测公司，拥有四大检测平台：NGS测序平台、荧光PCR平台、数字PCR平台、IHC平台，专业的生物信息学分析团队，提供肿瘤精准医疗基因检测产品40+款、精神类及心脑血管类药物安全用药基因检测产品20+款、遗传疾病基因检测产品多款。业务涉及全国多个省市多家医院 。 新唯医学将始终秉承惟精惟一，科技匠心的精神，将为客户提供精准的医疗服务和健康管理作为每一位新唯医学人的责任使命，坚定步伐，锐意前行。 目前集团已获得医疗机构执业许可证、临床基因扩增检验实验室资质，国家高新技术企业、安徽省专精特新企业、安徽省科技型中小企业、合肥市大数据企业，获得基因检测试剂盒等发明专利、实用新型专利及软件著作权40+项，并多次满分通过国家临检中心的室间质评。

First patients dosed at City of Hope and the University of Alabama at Birmingham DOC-RM recently featured as a Trial-in-Progress presentation at the 2026 ASCO Annual Meeting FDA Fast Track designation granted for unresectable or metastatic cutaneous melanoma Outpatient treatment approach without lymphodepleting chemotherapy or high-dose IL-2 Initial safety, biomarker and clinical activity results anticipated in Q4 2026 HOUSTON, July 30, 2026 (GLOBE NEWSWIRE) -- Diakonos Oncology Corp. , a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, today announced that the first patients have been dosed in DOC-RM, its Phase 1/2 clinical study evaluating DOC1021 (dubodencel) in patients with refractory melanoma, at City of Hope in Duarte, California, and the University of Alabama at Birmingham (UAB). This milestone follows the presentation of DOC-RM as a trial-in-progress abstract at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and represents the transition of the program into active clinical evaluation. "Roughly half of melanoma patients progress after checkpoint inhibition, and the options that follow are defined as much by their toxicity and cost as by their benefit," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "We are encouraged that the first patients have received DOC1021 treatment with no significant acute adverse events, consistent with our glioblastoma and pancreatic trials. We look forward to reporting initial preliminary results from DOC-RM by the end of the year.” DOC-RM is a multicenter Phase 1/2 study ( NCT07288112 ) evaluating safety, immune activity, and preliminary clinical efficacy of DOC1021 in patients with unresectable or metastatic melanoma who have progressed after prior therapies, including anti-PD-1 treatment. Patients receive two courses of DOC1021 in combination with pegylated interferon and an optional booster dose approximately six months later. Primary and secondary endpoints include safety, objective response, circulating tumor DNA (ctDNA), and immune biomarkers measured in tumor and peripheral blood. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “Patients whose melanoma progresses following anti-PD-1 therapy continue to face limited treatment options, highlighting the need for new immunotherapeutic strategies," said Yan Xing, MD, PhD, Associate Professor in the Department of Medical Oncology & Therapeutics Research and Principal Investigator at City of Hope. "DOC1021 is designed to utilize each patient's own tumor antigens to generate an individualized immune response. We’re excited to evaluate this investigational approach and contribute to the clinical development of DOC1021.” “The design of this trial offers the opportunity to study an investigational dendritic cell immunotherapy without the need for preconditioning chemotherapy or high-dose IL-2," said John Dubay, MD, Assistant Professor in the Department of Medicine, Division of Hematology and Oncology, and Principal Investigator at the University of Alabama at Birmingham. "The ability to administer DOC1021 in an outpatient setting may also help streamline treatment delivery and broaden patient access. We’re pleased to begin treating patients and participating in this important study.” DOC-RM is currently enrolling patients at City of Hope, the University of Alabama at Birmingham, Massachusetts General Hospital, Banner MD Anderson Cancer Center, UT Southwestern, HonorHealth Research Institute, University of North Carolina, and Atlantic Health. The trial is supported by Diakonos Oncology and a Product Development Research Grant from the Cancer Prevention and Research Institute of Texas (CPRIT). The study builds on preclinical data demonstrating antitumor activity across multiple tumor models, including B16F10 melanoma. DOC1021 received FDA Fast Track designation for unresectable or metastatic cutaneous melanoma in May 2026 . About DOC1021 DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy designed to generate a broad, personalized anti-tumor immune response. The therapy combines tumor lysate and amplified tumor-derived mRNA prepared from each patient's tumor with autologous dendritic cells, enabling presentation of the full spectrum of tumor antigens. The proprietary double-loading approach mimics the natural immune activation that occurs during viral infection, unlocking a synergistic and robust multi-antigen immune response while targeting the complete repertoire of the cancer antigen pool. Unlike many cell therapies, DOC1021 does not require any molecular modification or genetic engineering of immune cells, lymphodepleting chemotherapy, or high-dose IL-2 for administration, allowing for outpatient administration and broad access through community cancer centers. Diakonos is currently evaluating DOC1021 in three actively enrolling clinical trials: a Phase 1 pancreatic cancer (NCT04157127), a Phase 2 in glioblastoma (GBM) (NCT06805305), and a Phase 1/2 study in refractory melanoma (NCT07288112) supported by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021 for the treatment of pancreatic cancer, GBM, and unresectable or metastatic cutaneous melanoma. Diakonos also received Orphan Drug Designation for the GBM program in January 2024. About Diakonos Oncology Corp. Based in Houston, TX, Diakonos Oncology Corp. is a clinical-stage biotechnology company dedicated to revolutionizing cancer immunotherapy with its proprietary double-loaded patient-derived dendritic cell therapeutic platform. The company is focused on addressing critical, unmet medical needs in late-stage, aggressive, and lethal cancers. For more information visit: Investor & Media Contacts: Daniel Ferry LifeSci Advisors 617-430-7576 daniel@lifesciadvisors.com Jay Hartenbach Diakonos Oncology pr@diakonosoncology.com