DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:” “A multi-arms prospective, randomized phase II study to evaluate the best sequential therapeutic strategis in patients with metastatic non-small cell lung cancer harboring targetable genomic driver alterations”

开始日期2026-09-30

申办/合作机构-

DRKS00040588

/ RecruitingN/A

Encorafenib in Combination with Binimetinib in Patients with BRAFV600E-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC): A Retrospective, Multi-Centre Case Series in Germany - AIRCASE

开始日期2026-09-16

申办/合作机构

Pierre Fabre Pharma GmbH

CTR20261861

/ CompletedN/A

评估受试制剂恩考芬尼胶囊与参比制剂恩考芬尼胶囊（Braftovi®）作用于健康成年男性试验参与者的单中心、开放、随机、单剂量、交叉餐后生物等效性研究

主要研究目的研究餐后状态下单次口服受试制剂恩考芬尼胶囊与参比制剂恩考芬尼胶囊（Braftovi®）在健康成年男性试验参与者体内的药代动力学，评价餐后状态下口服两种制剂的生物等效性。次要研究目的研究受试制剂恩考芬尼胶囊和参比制剂“Braftovi®”在健康成年男性试验参与者中的安全性。

开始日期2026-06-21

申办/合作机构

齐鲁制药（海南）有限公司

100 项与恩考芬尼相关的临床结果

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100 项与恩考芬尼相关的转化医学

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100 项与恩考芬尼相关的专利（医药）

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623

项与恩考芬尼相关的文献（医药）

2026-12-31·CNS oncology

Tailored management of a melanoma patient with bleeding brain metastases and deep vein thrombosis with thrombectomy

Article

作者: Ceccarelli, Corrado ; Pastina, Ilaria ; Del Roscio, Davide ; De Angelis, Filippo ; Viterbo, Antonella ; Pieraccini, Massimo ; Arezzini, Luca

CASE PRESENTATION:

We describe a 62-year-old man with disseminated melanoma (initially staged pT2aN0M0, AJCC stage IB, 8th edition AJCC) who developed multiple brain metastases with hemorrhagic transformation, pulmonary embolism, retrobulbar progression with eyeball herniation, and deep vein thrombosis (DVT). After cerebral edema improved with corticosteroid tapering and the patient became asymptomatic, he started combination immunotherapy with ipilimumab (3 mg/kg q3w × 4) and nivolumab (1 mg/kg q3w × 4). Despite initial benefit, progression led to radiotherapy for retrobulbar lesion and subsequent targeted therapy with encorafenib (450 mg daily) and binimetinib (45 mg twice daily). Shortly after, the patient developed symptomatic left-leg DVT extending to the femoral vein with segmental pulmonary embolism. Given the contraindication to full anticoagulation, mechanical thrombectomy with the Indigo Aspiration System was performed, followed by prophylactic LMWH at reduced therapeutic dose (enoxaparin 1 mg/kg once daily due to recent thrombectomy and hemorrhagic risk from bleeding brain metastases). During targeted therapy, the patient experienced partial regression of brain, liver, and peritoneal metastases, although intracranial hemorrhage recurred later.

CONCLUSIONS:

This case highlights the value of a multidisciplinary, tailored approach integrating immunotherapy, radiotherapy, targeted therapy, and mechanical thrombectomy with no DVT recurrence observed following thrombectomy at 6-month follow-up.

2026-12-01·MOLECULAR BIOLOGY REPORTS

Recent progress in clinical and molecular biological research in rectal serrated lesions

Review

作者: Xu, Yuan ; Zeng, Xiaoyan ; Liu, Ling

Colorectal cancer ranks among the most common malignancies worldwide. Rectal serrated lesions represent a significant precancerous condition, accounting for approximately 30% of sporadic colorectal carcinomas. Their flat morphology and indistinct borders often lead to missed detection during routine colonoscopy. In addition, the complex classification system and considerable molecular heterogeneity of these lesions create challenges for clinical management, including diagnostic accuracy, risk stratification, and treatment decisions. Research in recent years has progressively clarified the unique oncogenic pathway associated with serrated lesions-referred to as the serrated pathway. Characteristic molecular events include mutations in b-raf murine sarcoma viral oncogene homolog B (BRAF) or kirsten rat sarcoma viral proto-oncogene (KRAS) mutations, CpG island methylator phenotype (CIMP), and microsatellite instability (MSI). Among these, the BRAF V600E mutation serves as the core driver event. Combination therapy with encorafenib and cetuximab, which targets this mutation, has been shown to improve outcomes in patients with BRAF-mutated metastatic colorectal cancer. Furthermore, Microsatellite Instability-High (MSI-H) lesions exhibit sensitivity to immune checkpoint inhibitors, offering novel options for personalized treatment. Concurrently, the application of technologies such as artificial intelligence (AI)-assisted endoscopy, molecular imaging, and liquid biopsy holds promise for improving the detection of early-stage lesions. This systematic review examines the current research landscape regarding rectal serrated lesions, covering an evolution of classification systems, elucidation of molecular and cellular mechanism, advances in diagnostic technology, and optimized treatment strategies. We further discussed molecular differences between the serrated pathway and the classical adenoma-carcinoma sequence, epigenetic regulatory mechanisms, tumour microenvironment characteristics, and personalized management strategies based on molecular subtyping. By synthesizing existing evidence, this review aims to provide theoretical guidance for the clinical management of rectal serrated lesions and lay the groundwork for future research.

2026-11-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Biomarker-guided treatment selection in metastatic colorectal cancer: A critical review of established and emerging therapies

Review

作者: Alkhazna, Shahd ; Tojjari, Alireza ; Pourbahrighesmat, Shamimeh ; Saeed, Anwaar

Metastatic colorectal cancer (mCRC) is increasingly managed according to mismatch repair status and actionable molecular alterations. In this structured narrative review, we separately examine mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) and microsatellite-stable/mismatch repair-proficient (MSS/pMMR) disease and distinguish established treatments from investigational strategies. In dMMR/MSI-H mCRC, immune checkpoint inhibition is the established first-line standard, with pembrolizumab and nivolumab plus ipilimumab producing durable disease control. In MSS/pMMR mCRC, tumor molecular findings guide targeted therapy. For BRAF V600E-mutant disease, encorafenib plus cetuximab with fluoropyrimidine-based chemotherapy is a first-line standard. HER2-directed therapy with tucatinib plus trastuzumab or trastuzumab deruxtecan and combined KRAS G12C and EGFR inhibition are established after prior treatment but are not approved in the first-line setting. Across MMR subgroups, rare NTRK or RET fusions can confer eligibility for tumor-agnostic TRK or RET inhibition, although CRC-specific cohorts remain small. In previously treated non-MSI-H/dMMR mCRC, STELLAR-303 was the first phase 3 trial to demonstrate a significant overall survival benefit with an immune checkpoint inhibitor-containing regimen, zanzalintinib plus atezolizumab. Other investigational strategies include additional immunotherapy combinations, EGFR-MET bispecific antibody therapy with amivantamab, T-cell-engaging bispecific antibodies, therapeutic cancer vaccines, cellular therapies, and microbiome-directed approaches. For each therapeutic class, we summarize the supporting evidence, define its place in the treatment sequence, and identify the remaining evidence gaps.

740

项与恩考芬尼相关的新闻（医药）

2026-10-21

·默沙东中国

默沙东将在2026 ESMO大会展示在研肿瘤管线III期关键研究首次结果及现有产品组合的持续创新潜力

默沙东将在2026 ESMO大会展示在研肿瘤管线III期关键研究首次结果及现有产品组合的持续创新潜力 INTerpath-001研究结果将于主席专题研讨会（Presidential Symposium）公布，首次发布在研个体化新抗原疗法intismeran autogene联合帕博利珠单抗的III期研究数据芦康沙妥珠单抗（sacituzumab tirumotecan，sac-TMT）TroFuse-005研究数据将于主席专题研讨会公布 KEYNOTE-C93研究数据将于主席专题研讨会公布，进一步探索帕博利珠单抗单药一线治疗在错配修复缺陷（dMMR）的晚期或复发性子宫内膜癌患者中的重要作用美国新泽西州罗威市，2026年10月13日——默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）宣布公司三项关键性临床研究的首次结果将于2026年欧洲肿瘤内科学会（ESMO）大会期间的最新突破性研究主席专题研讨会（Late-Breaking Presidential Symposia）公布。大会将于10月23日至27日在西班牙马德里举行。此外，公司还将在本次大会期间发布来自20余种肿瘤类型、覆盖肿瘤产品组合及研发管线的90余项摘要研究成果。 Marjorie Green博士默沙东实验室高级副总裁肿瘤学全球临床开发负责人 “ 本届ESMO大会公布的新数据，包括来自三项关键性研究的主席专题研讨会报告，彰显了默沙东业界领先的肿瘤产品组合及研发管线的广度与深度。我们很高兴首次分享intismeran[1]和芦康沙妥珠单抗[2]的III期研究结果，并同步展示来自公司肿瘤产品组合的最新研究进展，这进一步体现了我们致力于推动多种癌症领域创新研究的坚定承诺。 ” 将在ESMO大会公布的默沙东产品组合及在研管线关键数据包括： III期INTerpath-001研究首次数据发布。该研究评估在研个体化新抗原疗法intismeran autogene（intismeran；V940/mRNA-4157）联合帕博利珠单抗用于完全切除后的IIB-IV期黑色素瘤患者辅助治疗。相关结果将入选ESMO主席专题研讨会（摘要编号#LBA1，主席专题研讨会I）[3]。 III期TroFuse-005研究首次数据发布。该研究评估在研TROP2靶向抗体偶联药物（ADC）芦康沙妥珠单抗（sacituzumab tirumotecan，sac-TMT）用于既往接受含铂化疗以及程序性死亡受体-1（PD-1）抑制剂或程序性死亡配体-1（PD-L1）抑制剂治疗后发生疾病进展的晚期或复发性子宫内膜癌患者。相关结果将入选ESMO主席专题研讨会（摘要编号#LBA11，主席专题研讨会III）[4],[5]。 III期KEYNOTE-C93研究首次数据发布。该研究评估帕博利珠单抗[6]单药一线治疗既往未接受过系统性化疗或在接受辅助治疗后出现疾病复发的错配修复缺陷（dMMR）晚期或复发性子宫内膜癌患者的疗效。相关结果将入选ESMO主席专题研讨会（摘要编号#LBA12，主席专题研讨会III）[5]。 III期OptiTROP系列研究数据发布，评估芦康沙妥珠单抗（sacituzumab tirumotecan，sac-TMT）在非小细胞肺癌（NSCLC）中的应用，包括OptiTROP-Lung06研究（摘要编号#LBA66）在一线PD-L1阴性晚期非鳞状NSCLC患者中的研究结果；以及OptiTROP-Lung04研究（摘要编号#LBA67）在EGFR酪氨酸激酶抑制剂（TKI）治疗进展后EGFR突变NSCLC患者中的最终总生存期（OS）结果（口头报告专场1：转移性NSCLC）[7]。 III期LITESPARK-011研究最终分析结果发布。该研究评估贝组替凡[8]，默沙东首创口服缺氧诱导因子-2α（HIF-2α）抑制剂，与仑伐替尼[9]联合用于接受PD-1抑制剂或PD-L1抑制剂治疗后、伴透明细胞成分的晚期肾细胞癌患者的疗效。仑伐替尼是卫材研发的一种口服多靶点TKI药物（摘要编号#3587O，口头报告专场2：泌尿系统肿瘤-肾癌及尿路上皮癌）[10]。默沙东投资者活动：默沙东将在ESMO大会期间，于10月26日晚上7:30（欧洲中部时间）举办肿瘤业务投资者活动，分享公司肿瘤战略及项目进展。活动将在西班牙马德里举行，并同步线上播出。投资者、分析师、媒体以及公众可点击文章下方“阅读原文”访问活动。上述摘要及默沙东其他重点摘要的详细信息：乳腺肿瘤 Final OS analysis of sacituzumab tirumotecan versus chemotherapy in previously treated locally recurrent or metastatic triple-negative breast cancer: Phase III OptiTROP-Breast01. M. Li.[7] Presentation #4639RO, Rapid oral session 2: Breast cancer, advanced stage Results from KEYNOTE-B49: A Phase 3, randomized, double-blind study of pembrolizumab (pembro) vs placebo (pbo) plus chemotherapy (CT) in participants (pts) with HR+/HER2− advanced breast cancer (ABC). H. S. Rugo. Presentation #LBA51, Proffered paper session 2: Breast cancer, early and advanced stage Association between disease control and patient-reported functioning and quality of life in the ASCENT-04/KEYNOTE-D19 study. K. Kalinsky.[11] Presentation #4659P, Poster session: Triple negative breast cancer 消化道肿瘤 Adjuvant intismeran autogene plus FOLFIRINOX in resectable pancreatic ductal adenocarcinoma: Results from a Phase I study. D. J. Pinato.[3] Presentation #3151P, Poster session: Pancreatic cancer 泌尿系统肿瘤 Final analysis of the Phase 3 LITESPARK-011 study: Belzutifan (bel) plus lenvatinib (len) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti-PD-(L)1 therapy. D. Y. Heng.[10] Presentation #3587O, Proffered paper session 2: Genitourinary tumours, renal and urothelial Final protocol-prespecified analysis of the Phase 3 KEYNOTE-564 trial of adjuvant pembrolizumab versus placebo in clear cell renal cell carcinoma (ccRCC). T. K. Choueiri. Presentation #3589RO, Rapid oral session 2: Genitourinary tumours, renal and urothelial Enfortumab vedotin (EV) with or without pembrolizumab (P) as first-line (1L) treatment for cisplatin (cis)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC): Long-term follow-up analysis from EV-103 cohorts DE/A and K. J. P. Maroto Rey.[12] Presentation #4740RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial ctDNA analysis of the Phase 3 KEYNOTE-B15 trial: Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) + pembrolizumab (pembro) for participants (pts) with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin. J. A. Chatzkel.[12] Presentation #4734O, Proffered paper session 1: Genitourinary tumour, renal and urothelial Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) eligible for cisplatin in the Phase 3 KEYNOTE-B15 study. A. Gomez de Liano Lista.[12] Presentation #4738RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial Perioperative pembrolizumab (pembro) or enfortumab vedotin (EV) plus pembro in pts with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: Ad hoc analysis from KEYNOTE-905. A. Ullén.[12] Presentation #4733O, Proffered paper session 1: Genitourinary tumour, renal and urothelial Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) for locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a Phase 2 Study (2870-002/SKB264-II-06). X. Bian.[7] Presentation #4739RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial Updated results from the Phase 1b/2 KEYNOTE-365 cohort I: Pembrolizumab (pembro) + carboplatin and etoposide chemotherapy (chemo) or chemo alone for neuroendocrine prostate cancer (NEPC). G. von Amsberg. Presentation #2217RO, Rapid oral session: Genitourinary tumours, prostate, penile and testis 妇科肿瘤 Sacituzumab tirumotecan in previously treated advanced or recurrent endometrial cancer: Results from the Phase 3 TroFuse-005/ENGOT-en23/GOG-3095 study. D. Lorusso.[4],[5] Presentation #LBA11, Proffered paper session: Presidential Symposium III KEYNOTE-C93/GOG-3064/ENGOT-en15: Phase 3, randomized, open-label study of first-line (1L) pembrolizumab (pembro) vs carboplatin (C) + paclitaxel (P) in mismatch repair-deficient (dMMR) advanced or recurrent endometrial carcinoma (a/rEC). B. M. Slomovitz.[5] Presentation #LBA12, Proffered paper session: Presidential Symposium III Raludotatug deruxtecan (R-DXd) + bevacizumab (bev) in participants (pts) with platinum-resistant recurrent ovarian cancer (PROC): Results for cohort B-1 of the Phase 1b/2 REJOICE-Ovarian02 study. A. Oaknin.[13] Presentation #1247RO, Rapid oral session 2: Gynaecological cancers Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): An updated analysis of efficacy and tolerability from the Ph 2 part of REJOICE-Ovarian01. K. Hasegawa.[13] Presentation #1331P, Poster session: Gynaecological cancers NRG-GY020: Phase III randomized trial of radiation +/- MK-3475 (pembrolizumab) for newly diagnosed early-stage high intermediate risk (HIR) mismatch repair deficient (dMMR) endometrioid endometrial cancer. F. Backes.[14] Presentation #1239O, Proffered paper session: Gynaecological cancers Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) in post-platinum advanced mismatch repair proficient (pMMR) endometrial cancer (EC): Results from a Phase 2 study (2870-002/SKB264-II-06). L. Chen.[7] Presentation #1259P, Poster session: Gynaecological cancers 头颈肿瘤 Practical considerations for adopting perioperative pembrolizumab in locally advanced head and neck squamous cell carcinoma (LA HNSCC) in Europe: Insights from KEYNOTE-689. M. Oliva. Presentation #1580P, Poster session: Head and neck cancer, excluding thyroid 肺癌 Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: Randomized Phase 3 OptiTROP-Lung06 study. C. Zhou.[7] Presentation #LBA66, Proffered paper session 1: NSCLC, metastatic Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: Phase III OptiTROP-Lung04 study. W.F. Fang. [7] Presentation #LBA67, Proffered paper session 1: NSCLC, metastatic Calderasib (MK-1084), alone or in combination, for KRAS G12C-mutant metastatic non-small cell lung cancer (mNSCLC). M. A. N. Sendur.[15] Presentation #2680RO, Rapid oral session 2: NSCLC, metastatic Final analysis of adjuvant pembrolizumab (pembro) in resected early-stage non–small-cell lung cancer (NSCLC): Phase 3 PEARLS/KEYNOTE-091 study. M. E. O’Brien. Presentation #2511O, Proffered paper session: Non-metastatic NSCLC and other thoracic malignancies Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): IDeate-Lung01 updated results. M. Ahn.[13] Presentation #3842P, Poster session: SCLC 黑色素瘤 INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma (MEL). G. V. Long.[3] Presentation #LBA1, Proffered paper session: Presidential Symposium I STARBOARD Phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini) and pembrolizumab (pembro) vs placebo (pbo) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma. D. Schadendorf.[12] Presentation #2071O, Proffered paper session: Melanoma and other skin tumours Physician perspectives on defining cure in early-stage melanoma. H. M. Shaw. Presentation #2173eP, ePoster session: Melanoma Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: Primary analysis from HERTHENA-PanTumor01. M. McKean.[13] Presentation #2073RO, Rapid oral session: Melanoma and other skin tumours 跨瘤种 Final results of the TUXEDO-3 Phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases (BMs) and leptomeningeal disease (LMD). M. Preusser.[13] Presentation #690O, Proffered paper session: CNS tumours Calderasib monotherapy in various KRAS G12C-mutated advanced solid tumors: Results from the Phase 1 KANDLELIT-001 study. M Kwiatkowski.[15] Presentation #1039P, Poster session: Developmental therapeutics [1] 截至目前，intismeran autogene尚未获国家药品监督管理局（NMPA）批准 [2] 芦康沙妥珠单抗（sac-TMT）上市许可持有人为四川科伦博泰生物医药股份有限公司 [3] 与莫德纳合作 [4] 与科伦博泰合作 [5] 与欧洲妇科肿瘤试验网络（European Network for Gynaecological Oncology Trial, ENGOT）各研究组及GOG Foundation, Inc.（GOG）合作 [6] 截至目前，国家药品监督管理局（NMPA）批准帕博利珠单抗注射液下列适应症，除此以外其他适应症尚未获批： · 帕博利珠单抗适用于不可切除或转移性黑色素瘤的治疗。 · 帕博利珠单抗适用于由国家药品监督管理局批准的检测评估为PD-L1肿瘤比例分数（TPS）≥1%的表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的局部晚期或转移性非小细胞肺癌一线单药治疗。 · 帕博利珠单抗联合培美曲塞和铂类化疗适用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的转移性非鳞状非小细胞肺癌（NSCLC）的一线治疗。 · 帕博利珠单抗联合卡铂和紫杉醇适用于转移性鳞状非小细胞肺癌（NSCLC）患者的一线治疗。 · 帕博利珠单抗联合含铂化疗新辅助治疗并在手术后继续帕博利珠单抗单药辅助治疗，用于可手术切除的II、IIIA和IIIB期非小细胞肺癌患者。 · 帕博利珠单抗联合铂类和氟尿嘧啶类化疗药物用于局部晚期不可切除或转移性食管或胃食管结合部癌患者的一线治疗。 · 帕博利珠单抗单药用于由国家药品监督管理局批准的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥10）的、既往一线全身治疗失败的、局部晚期或转移性食管鳞状细胞癌（ESCC）患者的治疗。 · 帕博利珠单抗单药用于通过充分验证的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥1）的转移性或不可切除的复发性头颈部鳞状细胞癌（HNSCC）患者的一线治疗。 · 帕博利珠单抗用于通过充分验证的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥1）的可手术切除的局部晚期头颈部鳞状细胞癌成人患者，单药新辅助治疗，并在手术后联合放疗加或不加顺铂化疗进行辅助治疗，随后继续帕博利珠单抗单药治疗。 · 帕博利珠单抗单药用于KRAS、NRAS和BRAF基因均为野生型，不可切除或转移性微卫星高度不稳定型（MSI-H）或错配修复基因缺陷型（dMMR）结直肠癌（CRC）患者的一线治疗。 · 帕博利珠单抗和仑伐替尼联合经动脉化疗栓塞（TACE），用于治疗不可切除的非转移性肝细胞癌（HCC）患者。 · 帕博利珠单抗单药用于既往接受过索拉非尼或含奥沙利铂化疗的HCC患者的治疗。 · 帕博利珠单抗联合吉西他滨和顺铂用于局部晚期或转移性胆道癌（BTC）患者的一线治疗。 · 帕博利珠单抗联合化疗新辅助治疗并在手术后继续帕博利珠单抗单药辅助治疗，用于早期高危三阴性乳腺癌(TNBC)患者的治疗。 · 帕博利珠单抗单药用于不可切除或转移性微卫星高度不稳定型（MSI-H）或错配修复基因缺陷型（dMMR）成人晚期实体瘤患者 o既往接受过氟尿嘧啶类、奥沙利铂和伊立替康治疗后疾病进展的结直肠癌患者； o既往治疗后疾病进展且无满意替代治疗方案的其他实体瘤。 · 帕博利珠单抗联合含氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除或转移性HER2阴性胃或胃食管结合部腺癌患者的一线治疗。 · 帕博利珠单抗联合曲妥珠单抗、含氟尿嘧啶类和铂类药物化疗，用于经充分验证的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥1）的局部晚期不可切除或转移性HER2阳性胃或胃食管结合部腺癌患者的一线治疗。 · 帕博利珠单抗联合放化疗（CRT）用于国际妇产科联盟（FIGO）2014 III-IVA期宫颈癌患者的治疗。 · 帕博利珠单抗联合注射用维恩妥尤单抗用于局部晚期或转移性尿路上皮癌成人患者。 · 帕博利珠单抗联合卡铂和紫杉醇用于错配修复缺陷（dMMR）的原发晚期或复发性子宫内膜癌成人患者的一线治疗，随后以帕博利珠单抗单药维持治疗。 ·帕博利珠单抗联合紫杉醇（联合或不联合贝伐珠单抗）用于经充分验证的检测评估肿瘤表达 PD-L1（综合阳性评分（CPS）≥1）的既往接受过一线或二线全身治疗的铂耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者的治疗。 [7] 由科伦博泰主导，在中国开展 [8] 截至目前，国家药品监督管理局（NMPA）批准贝组替凡下列适应症，除此以外其他适应症尚未获批：适用于治疗不需要立即手术治疗的 von Hippel-Lindau（VHL）病相关肾细胞癌（RCC）、中枢神经系统（CNS）血管母细胞瘤或胰腺神经内分泌肿瘤（pNET）成人患者。 [9] 截至目前，国家药品监督管理局（NMPA）批准仑伐替尼下列适应症，除此以外其他适应症尚未获批： · 仑伐替尼和帕博利珠单抗联合经动脉化疗栓塞（TACE），用于治疗不可切除的非转移性肝细胞癌（HCC）患者。 · 仑伐替尼单药适用于既往未接受过全身系统治疗的不可切除的肝细胞癌患者。 · 仑伐替尼适用于进展性、局部晚期或转移性放射性碘难治性分化型甲状腺癌患者。 [10] 与卫材合作 [11] 与吉利德科学合作 [12] 与安斯泰来/辉瑞合作 [13] 与第一三共合作 [14] 由美国国家癌症研究所（NCI）资助 /由NRG Oncology牵头开展 [15] 与大鹏药品工业株式会社（Taiho Pharmaceutical Co., Ltd.）及Astex Pharmaceuticals（UK）（大塚制药株式会社全资子公司）合作开展若您想了解更多有关疾病知识的信息，请咨询医疗卫生专业人士 11-2026-CN-KEY-26079 关于默沙东在默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号），我们齐心协力追求共同的目标：我们发挥前沿科学的力量，在全球范围内拯救生命、改善生活。130多年来，我们通过研发重要药物和疫苗，为全人类带来希望。我们致力成为顶尖的研究密集型生物制药公司——当下，我们正处于研发前线，推出创新解决方案，以推进人类和动物疾病的预防和治疗。我们建立了一个多元、包容的全球员工体系，以负责的态度经营每一天，确保所有人、所有社区都能有一个安全、可持续和健康的未来。更多信息，请访问www.msd.com，并在X（前身为Twitter）、LinkedIn和Youtube平台关注我们。关于默沙东中国中国是默沙东全球增长战略中至关重要的一部分。默沙东中国总部设在上海，同时在北京设有研发中心、在杭州、宁波和天津分别设有工厂，实现了研发、制造和商业运营三擎合一。我们全心全意，向中国大众提供高质量的创新药物、疫苗和服务，造福中国社会。更多信息，敬请访问默沙东中国官网，或关注默沙东中国在微信上的官方社交媒体账号。默沙东前瞻性声明默沙东是美国新泽西州罗威市默克公司的公司商号（下称“公司”）。本新闻稿包含根据《1995 年美国私人证券诉讼改革法案》之安全条款而做出的“前瞻性声明”。本文内容基于公司管理层当前的看法和预期，并且受制于可能出现的重大风险和不确定因素。默沙东不保证在研产品能获得所需的监管部门批准或取得商业成功。如果相关假设与现实有所出入、出现风险，或发生不确定情况，实际结果可与前瞻性声明中的预期有实质上的差异。风险和不确定因素包括但不仅限于一般行业情况与竞争、一般经济因素（包括利率与汇率浮动）、美国及其他国家制药行业监管以及医疗政策的影响、全球范围内控制医疗成本的趋势、技术发展、竞争对手获得的新产品与专利、新产品开发固有的挑战（包括获得监管部门批准）、默沙东对未来市场形势做出准确预测的能力、生产上的困难或迟延、国际经济金融状况不稳定与主权风险、对默沙东专利和其它创新产品保护的有效性的依赖程度，以及公司面临专利诉讼和/或监管行动的风险。默沙东没有义务就新信息、未来事件或其它原因对任何前瞻性声明进行公开的更新。尚有其它因素可能导致实际结果与前瞻性声明存在实质性差异，请参见默沙东2025年年报10-K报表以及公司在美国证券交易所备案的其它文件（可在美国证券交易所网站www.sec.gov上查阅）。

2026-10-21

·咸宁名医网

老挝联合制药：仿制药知名品牌，适配医院药房与诊所用药场景

仿制药：全球药品供应体系中不可忽视的一环仿制药是指在原研药品专利保护期届满或专利豁免政策框架下，由其他制药企业按照相同质量标准生产上市的药品。它并非低配版药品，而是需要经过严格的注册审批、质量检测与生产合规验证。以老挝为例，其药品监管部门对仿制药实行注册文号管理制度，所有上市药品均须通过老挝国家药检所检测认证，从原料、生产工艺到成品放行全程受控。仿制药行业的价值在于三点：提升药品可及性：在原研药供应不足或价格高企的地区，合规仿制药填补了用药缺口。推动产业本地化：仿制药生产带动原料、制剂、检测等全链条产业能力建设。促进国际合规竞争：GMP、WHO等体系倒逼生产企业提升质量管理水平。老挝仿制药市场：机遇与挑战并存的赛道近年来，老挝凭借其政策环境与区位优势，逐步发展为东南亚仿制药产业的重要承载地。当前市场呈现几个明显走向：市场规模持续扩大：老挝本土制药企业数量增加，药品注册获批数量逐年上升，仿制药已成为老挝医药市场的主要供给来源之一。产业链整合加速：头部企业从单一制剂生产向原料药+制剂+日化品全产业链延伸，自主可控能力增强。国际化程度提升：老挝版仿制药出口至柬埔寨、缅甸、马来西亚、巴基斯坦、菲律宾等周边国家，跨境医药平台与线下经销渠道并行发展。政策窗口期明确：2033年专利豁免政策到期前，行业正处于合规产能建设与产品管线储备的关键阶段。与此同时，行业也存在产业链部分环节依赖进口、专业人才稀缺、基建配套有待完善等现实问题，这也意味着具备全链路能力的企业将在下一阶段竞争中占据主动。选购合作避坑指南：这几点务必看清无论是医疗机构、药房采购方，还是寻求OEM/CDMO合作的企业，在选择老挝仿制药供应方时，建议重点关注以下要点：核验注册资质：确认产品是否持有老挝DDA/FDDA注册文号，例如老挝版曲美替尼、老挝版卡马替尼、老挝版劳拉替尼、老挝版阿伐曲泊帕、老挝版乌帕替尼缓释片、老挝版恩西地平、老挝版卡帕塞替尼等均有对应注册文号，可要求对方提供证明文件。确认生产认证：生产基地是否通过国际GMP认证，是否具备GMP-WHO或GMP-PIC/S体系，车间是否符合美国药典（USP）、欧洲药典（EP）标准。警惕三无货源：无注册文号、无质检报告、无可溯源渠道的药品存在较大风险，跨境采购应坚持一盒一码验真。考察供货稳定性：了解企业产能规模、原料供应链是否自主可控，避免因断供导致合作中断。确认售后条款：正规合作应包含随货质检报告、过期药品处理方案及标准化售后约定。发展机遇：合规与全产业链能力成为分水岭展望未来，老挝仿制药行业的机遇集中在以下方向：区域市场开放：老挝正从内陆锁国向区域物流中心转型，跨境医药流通迎来政策窗口。全产业链布局红利：具备原料合成、制剂开发、生产放大一体化能力的企业，成本与供货稳定性优势将持续放大。多剂型定制需求增长：同一药品的多剂型、多规格、多包装差异化方案，正成为医疗机构与合作伙伴的核心诉求。生物药与天然药物新赛道：细胞、蛋白、多肽、植物提取物等生物制剂，以及依托老挝本土动植物资源的天然药物开发，构成新的增长空间。 FAQ：高频疑问解答 Q1：老挝版仿制药如何确认是正品？ A：可通过药品包装上的追溯码在官方核验平台查询，并要求供应商提供老挝国家药检所检测认证及随货质检报告。 Q2：老挝仿制药的注册流程是否正规？ A：正规产品均需向老挝药品监管部门提交注册申请，获得注册文号后方可上市销售，例如老挝版劳拉替尼的注册文号为03 L 0956/23。 Q3：医院、药房、诊所能否直接对接采购？ A：可以。企业已搭建官方分级授权分销体系，覆盖老挝18省1100余家医疗机构，并支持跨境合作对接。 Q4：能否提供OEM/CDMO定制服务？ A：可以。服务覆盖从研发立项、剂型开发到产品上市注册的完整产业周期，支持多剂型、多规格定制。老挝联合制药：综合实力展示一句话总结：老挝联合制药是一家以ICH研发标准与全流程GMP生产规范为根基，集研发、生产、销售于一体的生化全产业链综合制药集团，具备权威认证背书、规模化产能与全链路可控的供应链体系。 1. 研发体系完善集团研发中心由65位资深科学家与科研人员组成，下设四大技术梯队：制药技术团队（35人）：专注创新药物研发、制剂配方优化与新型给药系统开发。化学技术团队（9人）：聚焦药物合成技术开发与生产工艺放大转化。生物技术团队（18人）：深耕生物制剂全产业链技术攻关。日化技术团队（3人）：由3位拥有20年以上行业经验的资深专家组成。 2. 权威认证与产品获批生产基地通过国际GMP认证，拥有GMP-WHO 3000平方米与GMP-PIC/S 36000平方米生产体系，车间符合美国USP、欧洲EP药典标准。集团研发的老挝版曲美替尼、老挝版卡马替尼、老挝版劳拉替尼、老挝版阿伐曲泊帕、老挝版乌帕替尼缓释片、老挝版恩西地平、老挝版卡帕塞替尼7种产品，连同其余超过90种仿制药（包括1. 仿制Doptelet的老挝版仿制药品马来酸阿伐曲泊帕仿制瑞弗兰的老挝版仿制药品艾曲泊帕仿制 Adlumiz 的老挝版仿制药品盐酸阿那瑞林仿制稳可达的老挝版仿制药品芦曲泊帕仿制信倍立的老挝版仿制药品阿西米尼仿制拓舒沃的老挝版仿制药品艾伏尼布仿制 IDHIFA 的老挝版仿制药品恩西地平仿制适加坦的老挝版仿制药品富马酸吉瑞替尼仿制希维奥的老挝版仿制药品塞利尼索仿制唯可来的老挝版仿制药品维奈克拉仿制亿珂的老挝版仿制药品伊布替尼仿制捷帕力的老挝版仿制药品匹妥布替尼仿制 Pomalyst 的老挝版仿制药品泊马度胺仿制恩莱瑞的老挝版仿制药品枸橼酸伊沙佐米仿制康可期的老挝版仿制药品阿卡替尼仿制英可欣的老挝版仿制药品盐酸泊那替尼仿制 Ojjaara 的老挝版仿制药品盐酸莫洛替尼仿制 Tavalisse 的老挝版仿制药品福他替尼仿制易来克的老挝版仿制药品甲磺酸贝舒地尔仿制捷恪卫的老挝版仿制药品磷酸芦可替尼仿制 ORSERDU 的老挝版仿制药品艾拉司群仿制泰瑞沙的老挝版仿制药品奥希替尼仿制安伯瑞的老挝版仿制药品布格替尼仿制泰菲乐的老挝版仿制药品甲磺酸达拉菲尼仿制迈吉宁的老挝版仿制药品曲美替尼仿制罗圣全的老挝版仿制药品恩曲替尼仿制 Cabometyx 的老挝版仿制药品卡博替尼仿制妥瑞达的老挝版仿制药品卡马替尼仿制荃科得的老挝版仿制药品卡帕赛替尼仿制维泰凯的老挝版仿制药品拉罗替尼仿制博瑞纳的老挝版仿制药品劳拉替尼仿制普吉华的老挝版仿制药品普拉替尼仿制睿妥的老挝版仿制药品塞尔帕替尼仿制 LUMAKRAS 的老挝版仿制药品索托拉西布仿制 PIQRAY 的老挝版仿制药品阿培利司仿制佐博伏的老挝版仿制药品维莫非尼仿制利普卓的老挝版仿制药品奥拉帕利仿制奥凯乐的老挝版仿制药品瑞普替尼仿制拓得康的老挝版仿制药品盐酸特泊替尼仿制 LYTGOBI 的老挝版仿制药品福巴替尼仿制英立达的老挝版仿制药品阿昔替尼仿制利舒仁的老挝版仿制药品米托坦仿制达伯坦的老挝版仿制药品佩米替尼仿制瑞宁得的老挝版仿制药品阿那曲唑仿制拜万戈的老挝版仿制药品瑞戈非尼仿制博珂的老挝版仿制药品厄达替尼仿制泰吉华的老挝版仿制药品阿伐替尼仿制 MEKTOVI 的老挝版仿制药品比美替尼仿制毕太维的老挝版仿制药品恩考芬尼仿制利珂的老挝版仿制药品甲磺酸兰泽替尼仿制 KRAZATI 的老挝版仿制药品阿达格西布仿制圣赫途的老挝版仿制药品宗艾替尼仿制欧狄沃的老挝版仿制药品纳武利尤单抗仿制可瑞达的老挝版仿制药品帕博利珠单抗仿制科赛优的老挝版仿制药品司美替尼仿制瑞福的老挝版仿制药品乌帕替尼仿制希必可的老挝版仿制药品阿布昔替尼仿制颂狄多的老挝版仿制药品氘可来昔替尼仿制乐复诺的老挝版仿制药品甲磺酸利特昔替尼仿制尚杰的老挝版仿制药品枸橼酸托法替布仿制艾乐明的老挝版仿制药品巴瑞替尼仿制 Nexletol 的老挝版仿制药品贝派地酸仿制迈凡妥的老挝版仿制药品玛伐凯泰仿制 TRYVIO 的老挝版仿制药品阿普昔腾坦仿制卡理稳的老挝版仿制药品盐酸贝凡洛尔仿制翼弗瑞的老挝版仿制药品苯巴那酯仿制德力静的老挝版仿制药品苯磺酸美洛加巴林仿制丙通沙的老挝版仿制药品索磷布韦 / 维帕他韦仿制速福达的老挝版仿制药品玛巴洛沙韦仿制普瑞尼的老挝版仿制药品普托马尼仿制斯耐瑞的老挝版仿制药品富马酸贝达喹啉仿制诺和忻的老挝版仿制药品司美格鲁肽（含 3mg、7mg、14mg 三种规格，均为 10 片 / 板 ×3 板 / 盒口服片）仿制穆峰达的老挝版仿制药品替尔泊肽（含 2.5mg、5mg、7.5mg、10mg/0.5ml 支装，以及 10mg、20mg、30mg、40mg/2.4ml 支装，共八种规格的注射剂）仿制 Glyxambi 的老挝版仿制药品恩格列净 + 利格列汀仿制欧唐宁的老挝版仿制药品利格列汀仿制安达唐的老挝版仿制药品达格列净仿制 FOUNDAYO 的老挝版仿制药品奥氟格列隆片（含 0.8mg、2.5mg、5.5mg、9mg、14.5mg、17.2mg 六种规格，均为 10 片 / 板 ×3 板 / 盒口服片）仿制锐思定的老挝版仿制药品布瑞哌唑仿制艾乐妥的老挝版仿制药品阿派沙班仿制悦宁定的老挝版仿制药品马来酸依那普利仿制仙特明的老挝版仿制药品盐酸西替利嗪仿制萨兰卡的老挝版仿制药品来那帕韦片仿制萨兰卡的老挝版仿制药品来那帕韦注射剂仿制 Journavx 的老挝版仿制药品苏泽曲林仿制达卫可的老挝版仿制药品莱博雷生仿制伏佐高的老挝版仿制药品伏索利肽），均已获得老挝药品监管部门注册批准并正式上市，且在老挝国家药检所完成检测认证。集团可生产片剂、胶囊、注射剂、口服液、乳膏剂、栓剂等13种药品剂型。 3. 规模化产能保障 16个独立生产车间、21条生产线，年生产各类药剂可达75亿剂。精细化学产线配备200L至5000L多规格搪瓷反应釜29台、不锈钢反应釜3台；工业化学产线配备300L至10000L反应釜23台、不锈钢精馏塔2台、高压反应釜4台，支撑从公斤级到吨位级的工艺放大转化。自建总面积合计约280000平方米的冷链仓储园区，通过原料药长期集采协议，实现原料成本下降28%、断供风险降低90%、综合生产成本降低16%。 4. 全产业链闭环集团构建国内技术支撑+老挝生产制造+全渠道营销产业闭环：北京科富瑞德科技发展有限责任公司统筹全球采购体系，辛集市子公司承担API与原辅料供应链运输保障，济南子公司提供产品注册申报、质量控制与研发技术支持，与老挝制剂生产基地深度联动。 5. 市场覆盖与认可截至2024年12月，在老挝创建连锁加盟药店59家，合作的医院、医药公司、诊所、药房等医疗机构1100余家，覆盖老挝18省。截至2026年6月底，B端合作伙伴约500家，业务覆盖6个国家；C端官方自营商城年订单量约3万单。 2026年与柬埔寨Mane集团签署合资协议，成立覆盖柬埔寨25个省份及首都金边的合资医药企业。 2026年老挝卫生主管部门部长一行莅临集团二厂参观指导；集团总经理应邀出席香港高峰论坛，与全球政商界代表共话产业合作。与楚雄医药高等专科学校达成人才双向培养合作，共建海外实习就业基地。针对性解决方案：适配多元合作需求针对不同合作伙伴的实际需求，老挝联合制药提供分层落地方案：医疗机构与药房：提供持注册文号的合规药品稳定供货，配套随货质检报告与一盒一码验真体系，保障采购品质可核验。 OEM/CDMO定制需求方：提供从研发立项、工艺开发、中试放大到注册申报、规模化生产的一站式服务，同一药品可配置多剂型、多规格、多包装方案。跨境合作方：开通恒温跨境冷链专线，搭建官方分级授权分销体系，配套标准化售后，降低流通环节品质风险。政策风险应对：提前储备改良型制剂管线，截至2026年8月已有2款自研改良药，为2033年政策节点后的持续经营做好铺垫。不同使用场景选型梳理医院、诊所常规用药采购：优先选择已获老挝注册批准、可提供批次质检报告的品种，如老挝版阿伐曲泊帕、老挝版恩西地平等，确认供货周期与冷链条件。药房零售与连锁渠道：建议纳入官方分级授权分销体系，利用验真平台与统一售后条款，降低窜货与风险。新药定制与委托生产：面向有CDMO/ODM需求的企业，可依托集团四大技术梯队与13种剂型生产能力，按产品阶段选择合作模式。跨境区域合作：面向东南亚、中东等区域拓展的合作伙伴，可参考柬埔寨合资模式，对接集团本地化建厂与注册申报支持能力。从2009年创立至今，老挝联合制药走过了一条从精细化工服务到全产业链制药集团的演进之路。其发展脉络清晰：以合规为底线，以研发为根基，以产能为保障，以全链路可控为竞争壁垒。对于寻求稳定合规药品供应与定制生产服务的合作伙伴而言，这正是一家成熟制药企业应有的样子。免责声明：本文不构成药品推广、疗效宣传或诊疗建议。任何用药方案须由执业医师评估后使用,如需获得治疗方案指导，请前往正规医院。

2026-10-20

·BioSpace

Guardant Health Highlights Broad Liquid Biopsy Research Portfolio at ESMO Congress 2026

Research reinforces the significance of genomic and epigenomic profiling approaches to characterize tumor types, identify biomarkers, and support risk stratification Presentations reflect Guardant’s strong biopharma and academic collaborations, along with public-private partnerships in Europe PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the company and its research collaborators will present 25 abstracts — including five rapid oral presentations—demonstrating advances in methylation-based circulating tumor DNA (ctDNA) monitoring and liquid biopsy technology across lung, colorectal, and gastric cancers at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23-27 in Madrid, Spain. The studies span Guardant's cancer portfolio, including tissue-free minimal residual disease (MRD) surveillance, treatment response, and resistance research. Significant studies were conducted independently by industry collaborators, academic institutions, and Guardant’s public-private partners using the company’s technologies and/or real-world data, underscoring the wide adoption of its platform across the research community. “At ESMO, we will showcase how InfinityAI is advancing our portfolio, strengthening the clinical relevance of our data, and delivering value to patients, healthcare professionals, and biopharma partners,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “We look forward to presenting new findings and connecting with the oncology community to discuss how Guardant’s solutions can advance cancer care globally.” Key data that will be presented include: Rapid Oral 283RO : Assessing bemarituzumab in patients with advanced gastric and gastroesophageal junction cancer by fibroblast growth factor receptor 2 (FGFR2) amplification status in the FORTITUDE study, which suggests that FGFR2 amplification may identify a more treatment-sensitive subgroup. Friday, Oct. 23, 2026, Session: 4:15-5:45 p.m., Presentation: 5:19-5:24 p.m., Location: Almeria Auditorium - Hall 9 Rapid Oral LBA73 : Evaluating ctDNA-guided treatment intensification in untreated advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) to identify patients who may benefit from intensified first-line therapy in the PACE-LUNG study—a multicenter, Phase II trial of additional chemotherapy for patients with persistent EGFR-mutant ctDNA in plasma at Week 3 after starting first-line osimertinib. Saturday, October 24, 2026, Session: 8:30-10 a.m., Presentation: 8:30-8:35 a.m., Location: Almeria Auditorium - Hall 9 Rapid Oral 2636RO : Characterizing resistance mechanisms and predictors of early progression and long-term response to lorlatinib from the CROWN study. Findings suggest that baseline genomic complexity and on-treatment changes in methylation-based tissue-free assays may help identify patients at risk of early progression. Saturday, Oct. 24, 2026, Session: 8:30-10 a.m., Presentation: 9:05-9:10 a.m., Location: Almeria Auditorium - Hall 9 Poster 4403P : Using serial Guardant360 ® Liquid testing in a Phase 2 study with MD Anderson to examine clonal and subclonal resistance during anti-EGFR rechallenge in metastatic colorectal cancer to distinguish genuine resistance evolution from changes caused by fluctuating ctDNA levels, potentially improving patient selection for anti-EGFR rechallenge. Friday, October 23, 2026, Session: 3:15-4 p.m. Poster 2566P : Exploring post-surgical MRD and pathological complete response (pCR) after perioperative nivolumab in resectable Stage III NSCLC. In this exploratory analysis from NADIM II, pCR was associated with MRD negativity and excellent 5-year survival. In non-pCR patients, MRD negativity identified patients with favorable long-term outcomes, whereas detectable MRD defined a high-risk subgroup with early recurrence. Monday, October 26, 2026, Session: 12-12:45 p.m. Additional Guardant Health presentations at ESMO 2026 Abstract Full abstract title Session details Poster 424P Impact of blood draw weekday on turnaround time of Guardant360 ® CDx liquid biopsy: A real-world analysis Basic science Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 1026P Longitudinal ctDNA monitoring and radiological response to targeted therapies in early-phase clinical trials Developmental therapeutics Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 3275P Clinical utility and interpretation challenges of circulating comprehensive genomic profiling in routine oncology practice Pathology and molecular pathology Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 4279P Trastuzumab deruxtecan vs physician’s choice of chemotherapy in HR+, HER2-low metastatic breast cancer: A DESTINY-Breast06 ctDNA molecular response analysis Translational research and biomarkers Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 4311P Genomic landscape of cancer of unknown primary: Prognostic stratification through molecular profiling Translational research and biomarkers Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 4386P Beyond HER2 IHC: ERBB2 RNA-ISH stratifies benefit from T-DXd combinations Translational research and biomarkers Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 8P Clinical efficacy and predictive biomarkers of mTOR inhibition combined with endocrine therapy following progression on PI3K inhibitors in hormone receptor–positive metastatic breast cancer Advanced breast cancer, other Saturday, Oct. 24, 2026 Session: 12-12:45 p.m. Poster 45P Real-world elacestrant outcomes in ESR1-mutant HR+/HER2− metastatic breast cancer: A two-center NHS audit Advanced breast cancer, other Saturday, October 24, 2026 Session: 12-12:45 p.m. Poster 708P Clinical and molecular characteristics of leptomeningeal disease in metastatic breast cancer patients: A prospective observational registry study CNS tumors Saturday, October 24, 2026 Session: 12-12:45 p.m. Rapid oral 787RO ctDNA-guided re-treatment with encorafenib and cetuximab in patients with chemorefractory BRAFV600E mutated metastatic colorectal cancer (mCRC): The proof-of-concept single arm phase II BRICKET trial by GONO Rapid oral: Gastrointestinal tumors, lower digestive Saturday, October 24, 2026 Session: 2:45-4:15 p.m. Presentation: 2:45-2:50 p.m. Location: Alicante Auditorium - Hall 6 Poster 805P Baseline ctDNA and the efficacy of staged combination with encorafenib + binimetinib + cetuximab following encorafenib + cetuximab in patients with BRAF V600E-mutant mCRC from BAYONET trial Colon cancer Sunday, October 25, 2026 Session: 12-12:45 p.m. Rapid oral 3718RO Molecular response in KIT circulating ctDNA from StrateGIST 1: A phase 1/1b study of velzatinib (IDRX-42) in patients with advanced gastrointestinal stromal tumors Rapid oral: Sarcoma Monday, October 26, 2026 Session: 8:30-10 a.m. Presentation: 8:35-8:40 a.m. Malaga Auditorium - Hall 3 LBA - 4037 ctDNA negative hyperselection as an effect modifier of treatment sequence efficacy in left-sided RAS wild-type mCRC: pre-specified exploratory analysis of the CR-SEQUENCE TBD LBA 2882eP ctDNA assessment in patients with CLDN18.2+, HER2−, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in SPOTLIGHT TBD ePoster- 2813eP A decade of ctDNA-NGS in NSCLC: Real-world evolution of actionability and liquid-first clinical use ePoster: NSCLC, metastatic ePoster- 4548eP Combined cfDNA and ctDNA analysis improves prognostic models in patients referred for early-phase clinical trials ePoster: Translational research and biomarkers ePoster- 2734eP Clinical significance of comprehensive genomic profiling after negative initial CDx testing in advanced NSCLC ePoster: NSCLC, metastatic ePoster TiP- 3584eTiP Consolidation XELOX plus dostarlimab after chemoradiation with optional adjuvant dostarlimab in pMMR/MSS or MSI-low locally advanced rectal cancer: The IMMUNOSTAR phase II randomized trial (GOIRC-02-2024) ePoster Trial in progress: Rectal and anal cancer ePoster- 2783eP Sequential liquid biopsy in advanced NSCLC ePoster: NSCLC, metastatic ePoster- 4185eP The value of liquid biopsy in pleural mesothelioma as a biomarker strategy in clinical trials selection ePoster: Thoracic malignancies, other The full abstracts for Guardant Health at ESMO 2026 can be found on the ESMO website . Since 2020, Guardant has established public-private partnerships (PPPs) with leading healthcare institutions and cancer centers in Europe including The Royal Marsden NHS Foundation Trust (UK), Vall d’Hebron Institute of Oncology (Spain), and Policlinico Gemelli (Italy) to localize advanced diagnostic testing, generate clinical/economic evidence, and ultimately expand reimbursement and adoption. These partnerships make it possible to deliver high quality, clinical grade testing, similar to tests administered in the U.S., with local validation supporting research, delivering faster diagnoses, and increasing access to targeted treatments. To learn more about the PPPs and Guardant Health during ESMO, visit the team at Booth #8058. About Guardant360 ® Liquid Guardant360 Liquid is a blood-based test that analyzes tumor DNA fragments circulating in the blood (cfDNA) to identify genetic mutations in advanced solid tumors, helping oncologists find targeted therapies. It offers an alternative to tissue biopsies, providing comprehensive genomic profiling (CGP) to guide personalized treatment for a wide range of solid cancers including lung, breast, colorectal, and prostate cancer. Guardant360 Liquid is guideline-complete across all advanced solid tumors, and has been clinically validated in more than 1,500 publications and research abstracts. About Guardant Reveal ® Guardant Reveal is a tissue-free liquid biopsy test that detects minimal residual disease (MRD) and monitors recurrence in early-stage colorectal, breast, and lung cancers, helping oncologists guide treatment decisions. In addition to MRD detection, Reveal can be used for late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights. The first clinical-validation study of pan-cancer chemotherapy monitoring published in The Journal of Liquid Biopsy showed that Guardant Reveal predicts long-term patient benefit up to 18 months earlier than standard clinical measures. About Guardant360 ® CDx Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook . Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Contacts Investor Contact: Zarak Khurshid investors@guardanthealth.com Media Contact: Meaghan Smith press@guardanthealth.com

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100 项与恩考芬尼相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11053	恩考芬尼	L01EC03	DB11718

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
结直肠癌	美国	Array BioPharma, Inc.	2026-02-24
黑色素瘤	美国	Array BioPharma, Inc.	2026-02-24
转移性结直肠癌	美国	Array BioPharma, Inc.	2026-02-24
不可切除的黑色素瘤	美国	Array BioPharma, Inc.	2026-02-24
转移性非小细胞肺癌	澳大利亚	Pierre Fabre SA	2025-11-28
BRAF突变的甲状腺未分化癌	日本	Ono Pharmaceutical Co., Ltd.	2024-05-17
BRAF突变甲状腺癌	日本	Ono Pharmaceutical Co., Ltd.	2024-05-17
BRAF V600E突变非小细胞肺癌	美国	Array BioPharma, Inc.	2023-10-11
BRAF突变阳性黑色素瘤	日本	Ono Pharmaceutical Co., Ltd.	2020-11-27
BRAF 突变结直肠癌	日本	Ono Pharmaceutical Co., Ltd.	2019-01-08
BRAF V600 突变阳性黑色素瘤	欧盟	Pierre Fabre Médicament SAS	2018-09-19
BRAF V600 突变阳性黑色素瘤	冰岛	Pierre Fabre Médicament SAS	2018-09-19
BRAF V600 突变阳性黑色素瘤	列支敦士登	Pierre Fabre Médicament SAS	2018-09-19
BRAF V600 突变阳性黑色素瘤	挪威	Pierre Fabre Médicament SAS	2018-09-19
BRAF V600E突变结直肠癌	欧盟	Pierre Fabre Médicament SAS	2018-09-19
BRAF V600E突变结直肠癌	冰岛	Pierre Fabre Médicament SAS	2018-09-19
BRAF V600E突变结直肠癌	列支敦士登	Pierre Fabre Médicament SAS	2018-09-19
BRAF V600E突变结直肠癌	挪威	Pierre Fabre Médicament SAS	2018-09-19
BRAF V600E阳性黑色素瘤	美国	Array BioPharma, Inc.	2018-06-27
BRAF V600K 阳性黑色素瘤	美国	Array BioPharma, Inc.	2018-06-27

未上市

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适应症	最高研发状态	国家/地区	公司	日期
皮肤黑色素瘤	临床3期	阿根廷	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	澳大利亚	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	奥地利	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	比利时	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	巴西	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	加拿大	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	捷克	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	法国	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	德国	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	希腊	Pierre Fabre Medicament Information	2022-05-02

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06578559 (BRICKET, ESMO2026)	临床2期	转移性结直肠癌 BRAFV600E mutation \| KRAS \| NRAS ... 更多	16	Encorafenib and cetuximab (EC)	艱積顧鏇艱憲淵鹽鹹願(顧憲獵鏇鏇鑰壓糧製構) = 夢夢淵顧壓齋簾網艱顧夢衊範鹽廠艱鏇鬱範廠 (鏇廠餘壓積壓艱積遞窪 ) 更多	不佳	2026-10-23
NCT05706779 (NEORAF, ESMO2026)	临床2期	局部晚期恶性肿瘤新辅助 BRAF V600E mutation \| dMMR \| MSI	21	Cetuximab 500 mg/m2 IVEncorafenib 300 mg once daily + Cetuximab 500 mg/m2 IVEncorafenib 300 mg once daily	餘選鏇簾醖鏇憲鏇醖衊(簾齋鬱鹽願膚餘願蓋簾) = one patient discontinued due to a grade 3 arrhythmia possibly related to encorafenib 積鹽築艱鹹壓網醖襯糧 (顧窪鹽餘觸餘願網獵艱 ) 更多	积极	2026-10-23
ESMO2026	N/A	NRAS突变黑色素瘤 NRAS-mutant	5	Encorafenib plus binimetinib	窪鑰獵觸憲窪壓窪鹹艱(製築糧鏇窪鹹淵築夢膚) = 膚廠鹹積蓋築遞願獵願選膚選網鬱鹹醖憲淵願 (齋餘顧鬱餘襯願鹹構願 ) 更多	不佳	2026-10-23
JPRN-jRCTs031210510 (BAYONET, ESMO2026)	临床2期	BRAF V600E突变结直肠癌 BRAF V600E	30	Encorafenib + Binimetinib + Cetuximab	憲餘夢淵糧網齋襯願選(襯襯襯願範醖鬱淵襯範) = 鹽窪遞艱餘鏇觸鑰鏇範觸餘襯齋鹽糧襯鏇齋繭 (糧壓夢製範壓襯襯構鑰, 21.8 ~ 46.6) 更多	积极	2026-10-23
NCT06640166 (ECLYPse, ESMO2026)	临床2期	BRAF V600E突变结直肠癌二线 BRAF V600E	25	Encorafenib plus cetuximab (EC) beyond progression in combination with FOLFIRI	鏇範築選衊構壓壓築鹹(鬱糧壓積選鹽顧獵糧憲) = 廠簾鑰糧襯憲鏇網範壓壓願憲顧鏇鹽鏇鏇蓋膚 (遞襯繭網選艱觸鬱網顧, 51.7 ~ 93.6) 更多	积极	2026-10-23
NCT04526782 (IFCT-1904 ENCO-BRAF, ESMO2026)	临床2期	晚期非小细胞肺癌二线 \| 一线 BRAFV600E-mutant	96	Encorafenib 450mg once daily plus Binimetinib 45mg twice daily (treatment naive pts)	齋顧遞醖範鹹襯膚蓋網(窪簾獵構鹽鹹顧選窪憲) = 願糧糧繭遞鏇構繭範繭廠鏇襯衊鬱築簾窪淵齋 (鹽構構觸鹽廠遞膚遞網, 56.8 ~ 79.7) 更多	积极	2026-10-23
NCT04526782 (IFCT-1904 ENCO-BRAF, ESMO2026)	临床2期	晚期非小细胞肺癌二线 \| 一线 BRAFV600E-mutant	96	Encorafenib 450mg once daily plus Binimetinib 45mg twice daily (pretreated pts)	齋顧遞醖範鹹襯膚蓋網(窪簾獵構鹽鹹顧選窪憲) = 願廠選顧膚鹹網鹹構築廠鏇襯衊鬱築簾窪淵齋 (鹽構構觸鹽廠遞膚遞網, 44.1 ~ 78.4) 更多	积极	2026-10-23
ESMO2026	N/A	BRAF V600E突变结直肠癌一线 BRAF V600E	38	Encorafenib plus cetuximab combined with chemotherapy (BREAKWATER regimen)	鹹網蓋製獵願範衊齋網(淵遞窪鹽壓觸鬱艱糧衊) = 衊窪遞衊窪製鏇遞襯鏇醖觸鏇糧淵齋壓遞鹹範 (艱獵網顧窪淵餘製蓋簾 ) 更多	积极	2026-10-23
ESMO2026	N/A	BRAF V600E突变结直肠癌一线 BRAF V600E	38	Encorafenib plus cetuximab combined with chemotherapy (BREAKWATER regimen)	鹹網蓋製獵願範衊齋網(淵遞窪鹽壓觸鬱艱糧衊) = 醖廠壓廠觸鹹觸簾醖網醖觸鏇糧淵齋壓遞鹹範 (艱獵網顧窪淵餘製蓋簾 ) 更多	积极	2026-10-23
JPRN-jRCTs031210511 (TRIDENTE, ESMO2026)	临床2期	BRAF V600E突变结直肠癌 BRAF V600E	21	Encorafenib + Binimetinib + Cetuximab	鏇獵願蓋衊夢餘餘選製(選鏇窪觸襯選鏇選繭繭) = 蓋簾製齋積襯獵餘艱餘齋夢獵壓蓋網簾壓顧蓋 (獵鏇膚齋壓廠築鑰積製, 6.8 ~ 38.4) 更多	积极	2026-10-23
JPRN-jRCTs031210511 (TRIDENTE, ESMO2026)	临床2期	BRAF V600E突变结直肠癌 BRAF V600E	21	Encorafenib + Binimetinib + Cetuximab (without genomic alterations)	鏇獵願蓋衊夢餘餘選製(選鏇窪觸襯選鏇選繭繭) = 願蓋獵廠鬱構窪觸醖蓋齋夢獵壓蓋網簾壓顧蓋 (獵鏇膚齋壓廠築鑰積製 )	积极	2026-10-23
MELLODY (ESMO2026)	N/A	黑色素瘤	197	Encorafenib plus binimetinib	糧製壓鏇廠簾餘構鏇築(顧艱選願觸憲齋糧糧齋) = 構簾製艱夢壓蓋鹹膚膚鏇築製鏇糧餘鬱膚構糧 (範醖淵膚觸鏇鏇鏇積觸 ) 更多	积极	2026-10-23
MELLODY (ESMO2026)	N/A	黑色素瘤	197	Encorafenib plus binimetinib (1L)	艱襯壓遞鏇繭鹽鑰窪蓋(鑰廠醖糧築網夢蓋鬱齋) = 糧艱餘遞艱積鹹鏇衊範獵鹽範鹹簾顧糧獵蓋廠 (觸餘膚鏇齋憲襯艱鬱鬱, 39.8 ~ 64.4) 更多	积极	2026-10-23
NCT05195632 (OCEAN II, Pubmed \| Lung Cancer)	临床2期	转移性非小细胞肺癌 BRAF V600E	63	Encorafenib + Binimetinib	遞製夢遞艱選廠積膚壓(蓋襯壓觸觸鹽壓艱淵齋) = 衊遞製壓艱積窪齋顧選夢簾齋鹹範艱糧遞艱醖 (衊製選構鹽遞廠壓鹹夢, 45 ~ 72) 更多	积极	2026-10-01