Raludotatug deruxtecan

BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)--Results from an interim analysis of the dose-optimization part of the ongoing IDeate-Lung01 phase 2 trial showed ifinatamab deruxtecan (I-DXd) continues to demonstrate promising objective response rates in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). These data were featured today as part of a press conference and will be presented during an oral presentation (OA04.03) on Sunday at the 2024 World Conference on Lung Cancer (#WCLC24) hosted by the International Association for the Study of Lung Cancer. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada. Small cell lung cancer (SCLC) is the second most common type of lung cancer, accounting for about 15% of cases.1 SCLC is aggressive and progresses rapidly to the metastatic stage, which has a five-year survival rate of only 3%.2,3 Approximately 65% of all SCLC tumors have a moderate-to-high expression of the protein B7-H3, which is associated with disease progression and poor prognosis. “Most patients treated for small cell lung cancer experience rapid progression of disease and there is a high unmet need in the advanced setting,” said Charles M. Rudin, MD, PhD, Deputy Director of Memorial Sloan Kettering Cancer Center and Co-Director of the Fiona and Stanley Druckenmiller Center for Lung Cancer Research. “These interim results from the first part of the IDeate-Lung01 trial suggest that ifinatamab deruxtecan could play an important role in treating patients with pretreated extensive-stage small cell lung cancer and further research is warranted.” A confirmed objective response rate (ORR) of 54.8% (95% CI: 38.7-70.2) and 26.1% (95% CI: 14.3-41.1) were observed in patients with ES-SCLC receiving ifinatamab deruxtecan in the 12 mg/kg (n=42) and 8 mg/kg (n=46) cohorts, respectively, as assessed by blinded independent central review (BICR). Twenty-three partial responses (PR) were seen in the 12 mg/kg cohort. One complete response (CR) and eleven PRs were seen in the 8 mg/kg cohort. A median duration of response (DoR) of 4.2 months (95% CI: 3.5-7.0) and 7.9 months (95% CI: 4.1-NE) and a disease control rate (DCR) of 90.5% (95% CI: 77.4-97.3) and 80.4% (95% CI: 66.1-90.6) were observed in the 12 mg/kg and 8 mg/kg cohorts, respectively. The median duration of treatment was 4.7 months for the 12 mg/kg dose (range, 0.03-15.2) and 3.5 months for the 8 mg/kg dose (range, 0.03–13.9). Median progression-free survival (PFS) of 5.5 months (95% CI: 4.2-6.7) and 4.2 months (95% CI: 2.8-5.6) and median overall survival (OS) of 11.8 months (95% CI: 8.9-15.3) and 9.4 months (95% CI: 7.8-15.9) were observed in the 12 mg/kg and 8 mg/kg cohorts, respectively. The 12 mg/kg dose has been selected for the dose expansion part of the trial. Median follow-up was 15.3 months (95% CI: 13.6-16.2) in the 12 mg/kg cohort and 14.6 months (95% CI: 13.4-16.5) in the 8 mg/kg cohort as of data cutoff of April 25, 2024. In a subset of patients with brain target lesions at baseline, an intracranial ORR of 50.0% (95% CI: 18.7-81.3) and 66.7% (95% CI: 22.3-95.7) were observed as assessed by central nervous system (CNS) BICR in the 12 mg/kg (n=10) and 8 mg/kg (n=6) cohorts, respectively. In these patients, two intracranial CRs were seen in each cohort. Three and two intracranial PRs and five and two cases of stable disease (SD) were seen in the 12 mg/kg and 8 mg/kg cohorts, respectively. “The objective response rate and median overall survival of nearly a year along with the preliminary intracranial responses observed reinforces the potential for ifinatamab deruxtecan to improve outcomes for patients living with this difficult-to-treat type of lung cancer,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “We look forward to seeing additional results from the extension part of the IDeate-Lung01 phase 2 trial and the recently initiated IDeate-Lung02 phase 3 trial where we are evaluating ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer versus treatment of physician’s choice of chemotherapy.” “These results demonstrate promising objective response rates in patients with pre-treated extensive-stage small cell lung cancer, a patient population with a poor prognosis and limited treatment options,” said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “We are encouraged by these results supporting the potential of B7-H3 as an actionable target in small cell lung cancer and look forward to advancing our pivotal clinical development program for ifinatamab deruxtecan.” The safety profile seen in IDeate-Lung01 is consistent with that observed for ifinatamab deruxtecan in previous trials with no new safety signals identified. Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 50.0% and 43.5% of patients in the 12 mg/kg (n=42) and 8 mg/kg (n=46) cohorts, respectively. The most common treatment-related TEAEs (>20% of total population) across both doses include nausea (50.0% and 28.3%), decreased appetite (42.9% and 17.4%), anemia (35.7% and 13.0%), decreased neutrophil count/neutropenia (33.3% and 10.9%), white blood cell decreased (21.4% and 4.3%) and asthenia (1.4% and 13.0%). Five (11.9%) and four (8.7%) interstitial lung disease (ILD)/pneumonitis events were confirmed as treatment-related in the 12 mg/kg and 8 mg/kg doses, respectively, as determined by an independent adjudication committee. The majority of ILD events (four with 12 mg/kg, three with 8 mg/kg) were low grade (grade 1 or 2). There was one grade 3 (12 mg/kg) and one grade 5 (8 mg/kg) ILD. No ILD events were pending adjudication at the time of data cutoff of April 25, 2024. Treatment discontinuations due to adverse events occurred in 16.7% and 6.5% in the 12 mg/kg and 8 mg/kg cohorts, respectively. Patients in IDeate-Lung01 receiving ifinatamab deruxtecan received a median of two lines of therapy in both dose groups including a majority (76.1%) previously treated with immunotherapy. The median treatment duration was 4.7 months (range: 0.03-15.2) in the 12 mg/kg cohort and 3.5 months (range: 0.03-13.9) in the 8mg/kg cohort. Summary of IDeate-Lung01 Results Efficacy Measure Ifinatamab deruxtecan (12 mg/kg) n=42 Ifinatamab deruxtecan (8 mg/kg) n=46 Confirmed ORR, % (95% CI) 54.8% (38.7-70.2) 26.1% (14.3-41.1) CR, n (%) 0 1 (2.2%) PR, n (%) 23 (54.8%) 11 (23.9%) Stable disease (SD)/non-CR/non-PD, n (%) 15 (35.7%) 25 (54.3%) Progressive disease (PD), n (%) 2 (4.8%) 5 (10.9%) DCR, % (95% CI) 90.5% (77.4-97.3) 80.4% (66.1-90.6) DoR, median (95% CI), months 4.2 months (3.5-7.0) 7.9 months (4.1-NE) TTR, median (95% CI), months 1.4 months (1.0-8.1) 1.4 months (1.2-1.5) PFS, median (95% CI), months 5.5 months (4.2-6.7) 4.2 months (2.8-5.6) OS, median (95% CI), months 11.8 months (8.9-15.3) 9.4 months (7.8-15.9) CR, complete response; DCR, disease control rate; DoR, duration of response; ORR, objective response rate; OS, overall survival, PR, partial response; PD, progressive disease; PFS, progression-free survival; TTR, time to response; SD, stable disease About the IDeate-Lung01 Trial IDeate-Lung01 is a global, multicenter, randomized, open-label two-part phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with ES-SCLC. In the first part of the trial (dose optimization), patients were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. In the second part (extension), patients were previously treated with a minimum of two previous lines of systemic therapy. In the first part of the trial, patients were randomized 1:1 to receive either 8 mg/kg or 12 mg/kg of ifinatamab deruxtecan. In the second part of the trial, patients will receive the recommended dose for expansion (12 mg/kg) of ifinatamab deruxtecan. The primary endpoint is ORR as assessed by BICR. Secondary endpoints include DoR, PFS, OS, DCR, time to response and overall safety profile. Intracranial ORR was assessed by BICR as an exploratory analysis. IDeate-Lung01 is enrolling patients in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov. About Small Cell Lung Cancer More than 2.48 million lung cancer cases were diagnosed globally in 2022.6 SCLC is the second most common type of lung cancer, accounting for approximately 15% of cases.1 SCLC is aggressive and progresses rapidly to the metastatic stage, which has a five-year survival rate of only 3%.2,3 While conventional first-line therapy for patients with advanced SCLC may help some patients live longer, the current second-line standard of care offers limited clinical benefit and new treatment approaches are needed. About B7-H3 B7-H3 is a transmembrane protein that belongs to the B7 family of proteins which bind to the CD28 family of receptors that includes PD-1.11,12 B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target.4,12,13,14,15 There are currently no B7-H3 directed medicines approved for the treatment of any cancer. About Ifinatamab Deruxtecan Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Ifinatamab deruxtecan is being evaluated in a global development program, which includes IDeate-Lung01, a phase 2 monotherapy trial in patients with previously treated ES-SCLC; IDeate-Lung02, a phase 3 trial in patients with relapsed SCLC versus investigator’s choice of chemotherapy; IDeate-Lung03, a phase 1b/2 trial in patients with ES-SCLC in combination with atezolizumab with or without carboplatin as first-line induction or maintenance therapy; IDeate-PanTumor01, a phase 1/2 first-in-human trial in patients with advanced solid malignant tumors in collaboration with Sarah Cannon Research Institute (SCRI) with study operational oversight and delivery provided through SCRI’s early phase oncology clinical research organization, SCRI Development Innovations in Nashville, TN; and, IDeate-PanTumor02, a phase 2 trial in patients with recurrent or metastatic solid tumors. Ifinatamab deruxtecan was granted orphan drug designation by the U.S. Food and Drug Administration in April 2023 and by the European Commission in February 2024 for the treatment of SCLC. About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024, the global co-development and co-commercialization agreement was expanded to include MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, which they will jointly develop and commercialize worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for MK-6070. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com. Merck’s Focus on Cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www-merck-com.libproxy1.nus.edu.sg/research/oncology/. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

● 3期研究结果明确了第一三共和阿斯利康共同开发的优赫得®治疗二线转移性胃癌的疗效。 ● DESTINY-Gastric04期中研究显示优赫得®疗效更优，独立数据监察委员会建议研究结果提前揭盲。 ● 该研究结果将与全球监管机构分享。 　　东京和新泽西州巴斯金里奇--（2025年3月3日）——3期研究DESTINY-Gastric04的总体阳性结果表明，与雷莫西尤单抗+紫杉醇相比，德曲妥珠单抗（商品名 - 优赫得®）为HER2阳性（IHC 3+或IHC 2+/ISH+）转移性胃或胃食管结合部（GEJ）腺癌患者带来具有显著统计学差异和临床意义的总生存期（OS）改善。 　　期中分析中独立数据监察委员会观察到优赫得®疗效更优，建议提前揭盲。 　　德曲妥珠单抗是一款采用独有技术设计的靶向HER2的DXd抗体偶联药物（ADC），该药物由第一三共研制，并由第一三共和阿斯利康共同开发和商业化。 　　胃癌预后较差，尤其是晚期胃癌，其五年生存率为5%至10%1,2。在HER2阳性胃癌一线转移治疗中，使用含曲妥珠单抗的方案治疗出现疾病进展后，在DESTINY-Gastric04的研究结果出来之前，尚无靶向HER2的药物可在二线转移治疗中带来生存期获益3,4。 　　根据随机2期研究DESTINY-Gastric01以及2项单臂2期研究DESTINY-Gastric02和DESTINY-Gastric06的研究结果，优赫得®目前已在超过65个国家/地区获得批准。DESTINY-Gastric04是优赫得®治疗HER2阳性晚期胃癌的首个3期研究。 Ken Takeshita 博士 第一三共肿瘤研发部全球负责人 　　优赫得®是首个且唯一在二线HER2阳性转移性胃癌患者随机3期研究中显示出生存期改善的HER2靶向药物，巩固了我们之前在其他早期胃癌研究中取得的研究成果。根据DESTINY-Gastric04的研究结果，我们将与全球监管机构合作，争取在优赫得®在尚未成为二线治疗选择的地区获得批准。 　　DESTINY-Gastric04临床研究显示的安全性与优赫得®既往安全性一致。 　　DESTINY-Gastric04数据将在即将召开的医学会议上公布，并与全球监管机构分享。 　　　关于DESTINY-Gastric04　　　 　　DESTINY-Gastric04是一项全球、随机、开放性三期研究，在使用含曲妥珠单抗方案治疗期间或治疗后出现疾病进展的HER2阳性（IHC 3+或IHC 2+/ISH+）转移性胃或GEJ腺癌患者中，评价德曲妥珠单抗（6.4 mg/kg）与雷莫西尤单抗和紫杉醇相比的疗效和安全性。 　　主要终点为OS。次要终点包括研究者评估的无进展生存期、客观缓解率、缓解持续时间、疾病控制率和安全性。 　　DESTINY-Gastric04在亚洲、欧洲、南美洲入组了494 例病人。欲了解有关该研究的更多信息，请访问ClinicalTrials.gov。 　　　　关于HER2阳性胃癌　　　　 　　胃癌是全球第五大常见癌症，也是全球第五大癌症相关死亡原因1,2。2022年新增胃癌确诊病例约100万2。胃癌的预后较差，尤其是晚期胃癌，五年生存率为5%至10%1,2。  　　HER2是一种酪氨酸激酶受体促生长蛋白，在包括胃癌在内的多种肿瘤细胞表面均有表达4。大约五分之一的胃癌被认为是HER2阳性4,5。 　　在HER2阳性胃癌一线转移治疗出现疾病进展后，之前尚无靶向HER2的药物可在二线随机临床试验中表明其生存获益3。 　　　　　　关于优赫得®　　　　　　 　　优赫得®是一款靶向HER2的ADC。采用第一三共独有的DXd-ADC技术设计，是第一三共肿瘤产品组合中的领先ADC产品，也是阿斯利康ADC科学平台中最先进的项目。德曲妥珠单抗由一种HER2单克隆抗体通过可裂解四肽连接子与若干拓扑异构酶I抑制剂有效载荷（依喜替康衍生物，DXd）连接组成。 　　基于DESTINY-Breast03研究获得的结果，德曲妥珠单抗（5.4 mg/kg）已在全球超过75个国家/地区获得批准，用于治疗既往在转移阶段或在新辅助治疗期间或辅助治疗期间接受过一种抗HER2治疗方案且在治疗期间或完成治疗之后6个月内出现疾病复发的不可切除或转移性HER2阳性（[IHC]3+或[ISH]+）乳腺癌成人患者。 　　基于DESTINY-Breast04研究获得的结果，德曲妥珠单抗（5.4 mg/kg）已在全球超过75个国家/地区获得批准，用于治疗既往在转移阶段接受过一种全身治疗，或在辅助化疗期间或完成辅助化疗后6个月内出现疾病复发的不可切除或转移性HER2低表达（IHC 1+或IHC 2+/ISH-）乳腺癌成人患者。 　　基于DESTINY-Breast06研究获得的结果，德曲妥珠单抗（5.4 mg/kg）在美国获得批准，用于根据美国食品药品监督管理局（FDA）批准的检测方法确定在转移阶段接受一种或多种内分泌治疗后出现疾病进展的HR阳性、HER2低表达（IHC 1+或IHC 2+/ISH-）或HER2超低表达（IHC 0，伴膜染色）、不可切除或转移性乳腺癌成人患者。 　　基于DESTINY-Lung02和/或DESTINY-Lung05研究获得的结果，德曲妥珠单抗（5.4 mg/kg）已在全球超过50个国家/地区获得批准，用于治疗通过当地或地区批准的检测方法检出肿瘤存在HER2（ERBB2）激活突变且既往接受过一种全身治疗的不可切除或转移性非小细胞肺癌（NSCLC）成人患者。该适应症能否在中国和美国完全批准取决于是否可通过确证性研究验证和确定可提供临床获益。 　　基于DESTINY-Gastric01、DESTINY-Gastric02和/或DESTINY-Gastric06研究获得的结果，德曲妥珠单抗（6.4 mg/kg）已在全球超过65个国家/地区获批，用于治疗既往接受过基于曲妥珠单抗的治疗方案的局部晚期或转移性HER2阳性（IHC 3+或IHC 2+/ISH+）胃或GEJ腺癌成人患者。中国于2024年8月基于DG06研究获得附条件批准，用于治疗既往接受过两种或两种以上治疗方案的局部晚期或转移性HER2阳性成人胃或胃食管结合部腺癌患者，该适应症在中国的完全批准取决于能否通过确证性研究验证和确定可提供临床获益。 　　基于DESTINY-PanTumor02、DESTINY-Lung01和DESTINY-CRC02研究的疗效结果，德曲妥珠单抗（5.4 mg/kg）已在巴西、以色列、俄罗斯和美国获批，用于治疗既往接受过全身治疗且无满意替代治疗选择的不可切除或转移性HER2阳性（IHC 3+）实体瘤成人患者。该适应症能否完全批准取决于是否可通过确证性研究验证和确定可提供临床获益。 　　　关于优赫得®临床开发计划　　　 　　旨在评价德曲妥珠单抗单药治疗多种HER2靶向癌症的疗效和安全性的全面临床研发计划正在全球范围内进行。联合免疫治疗等其他抗肿瘤治疗的研究也在进行中。 　　关于第一三共和阿斯利康的合作　　 　　第一三共与阿斯利康分别于2019年3月和2020年7月达成全球合作，共同开发和商业化优赫得®和达卓优® (DATROWAY®)，在日本市场第一三共拥有各款ADC产品的独家权益。第一三共负责优赫得®和达卓优® 的生产和供应。 　　　关于第一三共ADC产品组合　　　 　　第一三共的ADC产品组合包括7款处于临床开发阶段的ADC，这些ADC基于第一三共开发的两个ADC技术平台。 　　目前临床开发进展最为领先的ADC平台当属第一三共的DXd ADC技术平台，每款ADC由单克隆抗体通过可裂解四肽连接子与多个拓扑异构酶I抑制剂有效载荷（一种依喜替康衍生物，DXd）连接组成。DXd ADC产品组合目前包括靶向HER2的ADC德曲妥珠单抗和靶向TROP2的ADC DATROWAY，上述两款产品目前正由第一三共与阿斯利康共同开发并在全球范围内商业化。Patritumab deruxtecan（HER3-DXd，靶向HER3的ADC）、ifinatamab deruxtecan（I-DXd，靶向B7-H3的ADC）、raludotatug deruxtecan（R-DXd，靶向CDH6的ADC）目前正由第一三共与Merck & Co., Inc（Rahway, NJ, USA）共同开发并在全球范围内商业化。DS-3939是一款靶向TA-MUC1的ADC，目前正由第一三共开发。 　　第一三共的第二个ADC平台由单克隆抗体与改良吡咯并苯并二氮杂卓 (PBD) 有效载荷连接组成。DS-9606是一款靶向CLDN6的PBD ADC，是计划利用该平台并处于临床开发阶段的几种ADC中的第一种ADC。 　　I-DXd、HER3-DXd、R-DXd、DS-3939和DS-9606均为在研药物，尚未在任何国家/地区获批用于任何适应症。安全性和疗效尚未确定。 　　　　　　关于第一三共　　　　　　 　　第一三共是一家为社会可持续发展做贡献的创新型全球医疗保健公司，致力于发现、开发和提供新的标准疗法，以提高世界各地患者的生活质量。第一三共专注制药行业120余年，凭借其世界一流的科学和技术，为癌症、心血管疾病和其他医疗需求远未得到满足的疾病患者研发新的治疗方法和创新药物。如欲了解更多信息，请访问www.daiichisankyo.com。 参考文献： 1.Casamayor M, et al. Ecancermedicalscience. 2018;12:883. 2.Globocan 2022. Stomach Cancer. Accessed December 2024. 3.Mitani S, et al. Cancers. 2020;12(2):400. 4.Abrahao-Machado LF, et al. World J Gastroenterol. 2016;22(19):4619-25.   5.Iqbal N, et al. Mol Biol Int. 2014:852748.   声明: 1.本材料不用于任何推广目的，相关信息亦不应作为治疗或使用建议。如有相关问题请咨询医疗卫生专业人士。 2.本文涉及未在中国获批的产品或适应症，第一三共不推荐任何未获批药品/适应症的使用。 3.截止获批当日，根据ClinicalTrials.gov数据库，DB06适应症为全球市场唯一获批适应症。