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癌症分子标靶治疗学

市场调查报告书

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1632465

全球 DLL3 标靶治疗市场：核准剂量、价格和临床试验趋势（2025 年）

Global DLL3 Targeted Therapies Market, Approved Drugs Dosage, Pricing & Clinical Trials Insight 2025

出版日期: 2025年01月01日 | 出版商:

KuicK Research | 英文 140 Pages | 商品交期: 最快1-2个工作天内

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简介目录图表

Delta 样配体 3 (DLL3) 是一种细胞表面蛋白，主要在神经内分泌肿瘤（例如小细胞肺癌 (SCLC)）中表达，但在正常成人组织中表达最少。这种选择性表达使 DLL3 成为治疗选择有限的恶性癌症的一个有吸引力的治疗标靶。透过标靶 DLL3，新型疗法可以有效针对肿瘤细胞，同时最大限度地减少对健康组织的损害，符合精准肿瘤学的原则。 2024 年首个针对 DLL3 的疗法获得批准是一个关键进展，引发了人们对针对这一独特生物标记的治疗和诊断进展的兴趣日益浓厚。

安进公司于 2024 年 5 月批准 Imdeltra (tarlatamab)，这大大改变了 DLL3 标靶治疗的格局。 Imdelltra 是第一个针对 DLL3 的治疗药物，代表了肿瘤学领域的显着进步。双特异性T细胞接合剂（BiTE）已获准用于治疗接受铂类化疗后病情进展的广泛期小细胞肺癌（ES-SCLC）成年患者。此加速核准凸显了其临床前景，这得益于临床试验中观察到的显着反应率和反应持续时间（DoR）。然而，持续的验证试验对于进一步确定其治疗效果至关重要。

从商业角度来看，Imdelltra 取得了令人印象深刻的早期成功，仅在美国市场推出的头几个月就实现了超过 4500 万美元的销售额。这一早期表现反映了对 ES-SCLC 创新疗法的巨大需求，并使 Imdelltra 成为这一发展中治疗类别的重要竞争者。 Imdeltra 的商业成功引发了人们对 DLL3 标靶疗法的兴趣和投资激增，并促成了多项合作和许可协议的达成，各大公司纷纷争夺这一前景广阔的市场的占有率。

本报告研究了全球 DLL3 标靶治疗市场，并概述了市场以及药物趋势、临床试验趋势、区域趋势以及进入市场的公司的竞争格局。

Global & Regional Market Overview
DLL3 Targeted Drugs Available In Market:1 Drug, Imdelltra (Tarlatamab)
Approved Drug Dosage, Sales & Pricing Insight
DLL3 Targeted Therapies Proprietary Platforms: > 10 Platform
Role of DLL3 As Diagnostic & Prognostic Markers
DLL3 Targeted Drugs Clinical Trials Insight By Company, Indication and Phase: > 10 Drugs
Global DLL3 Targeted Therapies Clinical Development Trends By Indication

Delta-like ligand 3 (DLL3) is a cell surface protein that is predominantly expressed in neuroendocrine tumors, such as small cell lung cancer (SCLC), while exhibiting minimal presence in normal adult tissues. This selective expression renders DLL3 an attractive therapeutic target for aggressive cancers that have limited treatment alternatives. By targeting DLL3, novel therapies can effectively target tumor cells while reducing damage to healthy tissues, aligning with the principles of precision oncology. The approval of the first DLL3-targeted therapy in 2024 represented a pivotal development, sparking increased interest in both treatment and diagnostic advancements focused on this distinctive biomarker.

The approval of Imdelltra (tarlatamab) by Amgen in May 2024 significantly transformed the landscape for DLL3-targeted therapies. As the first therapy aimed at DLL3, Imdelltra signifies a remarkable progression in the field of oncology. This bispecific T-cell engager (BiTE) received approval for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose condition had progressed following platinum-based chemotherapy. Its accelerated approval, driven by notable response rates and duration of response (DoR) observed in clinical trials, highlights its clinical promise. Nevertheless, ongoing confirmatory studies are essential to further substantiate its therapeutic efficacy.

From a commercial perspective, Imdelltra has achieved impressive initial success, generating over US$ 45 Million in sales within its first few months solely in the US market. This early performance reflects the substantial demand for innovative therapies in ES-SCLC and positions Imdelltra as a significant contender in this developing therapeutic category. Its commercial success has sparked a surge of interest and investment in DLL3-targeting therapies, leading to numerous collaborations and licensing agreements as companies compete for a stake in this promising market.

Boehringer Ingelheim's Obrixtamig (BI 764532), a DLL3/CD3 bispecific antibody, represents the next most advanced clinical candidate in this domain. Developed using the OGAP(R) Discovery Platform, Obrixtamig has received FDA Fast Track designation for small cell lung cancer, underscoring its potential to offer a new therapeutic option for patients. Although clinical development is ongoing, its advancement signifies the increasing competition and variety of strategies within the DLL3-targeting sector.

The approval and initial success of Imdelltra have catalyzed a surge in licensing agreements aimed at expediting the development of innovative DLL3-targeted therapies. For example, in January 2025, Innovent Biologics entered into a collaboration and exclusive licensing agreement with Roche to further develop IBI3009, a novel DLL3-targeted antibody-drug conjugate (ADC). With IND approvals secured in Australia, China, and the US, and the first patient dosed in December 2024, this partnership highlights the potential of ADCs in enhancing DLL3-targeting strategies. Roche's intention to assume full development responsibilities after the initial phases further emphasizes the strategic significance of this collaboration, with Innovent poised to receive up to US$ 1 billion in milestone payments along with tiered royalties on net sales.

In addition to therapeutic uses, DLL3 is being utilized as a diagnostic tool, thereby increasing its overall market potential. Researchers at Memorial Sloan Kettering Cancer Center have created an imaging technology that employs a radioactive particle binding to DLL3, facilitating more accurate detection of DLL3-expressing lung and prostate cancers through PET scans. This diagnostic advancement could be pivotal in identifying patients likely to benefit from DLL3-targeted therapies, such as Imdelltra, thus optimizing treatment outcomes and broadening the market for these agents.

The integration of substantial clinical evidence, impressive commercial success, and continuous research and development efforts establishes the DLL3-targeting therapies market as a vibrant and swiftly expanding area within oncology. Numerous companies are progressing their development pipelines, forming strategic partnerships, and investigating novel diagnostic uses, indicating that the future of DLL3-targeted therapies is highly promising for both patients and stakeholders. As the market evolves, it is expected to become a fundamental component in the treatment of cancers associated with DLL3 expression.

1. Introduction To DLL3 Targeted Therapies

1.1 Overview
1.2 History & Evolution Of DLL3 Targeted Therapies
1.3 Role Of DLL3 As Diagnostic & Prognostic Markers

2. DLL3 Targeting Approaches, Mechanism & Commercial Aspects

2.1 Antibody Drug Conjugates
2.2 Antibodies
2.3 Cell Therapies
2.4 Antibody Radionuclide Conjugates
2.5 Antibody Photoabsorber/Photosensitizer Conjugate

3. DLL3 Targeted Therapies Proprietary Platforms

3.1 Platforms Used To Develop DLL3 Targeted Therapies
3.2 Potential Platforms For DLL3 Targeted Therapies Development

4. Imdelltra - 1st Approved DLL3 Targeted Drug

4.1 Clinical Overview & Patent Insight
4.2 Treatment Cycle Pricing & Dosage Analysis
4.3 Sales Analysis

5. DLL3 Targeted Therapies Market & Clinical Trends Insights

5.1 Current Market Trends, Developments & Clinical Trials Assessment
5.2 Future Commercialization Opportunity

6. DLL3 Targeted Therapies Research & Market Trends by Region

6.1 US
6.2 UK
6.3 EU
6.4 Canada
6.5 Australia
6.6 China

7. Global DLL3 Targeted Therapies Clinical Development & Market Insight By Indication

7.1 Small Cell Lung Cancer
7.2 Large Cell Neuroendocrine Cancer
7.3 Neuroendocrine Prostate Cancer
7.4 Gastroenteropancreatic Neuroendocrine Tumors
7.5 Glioma

8. Global DLL3 Targeted Drugs Clinical Trials Overview

8.1 By Company
8.2 By Fast Track Status
8.3 By Indication
8.4 By Location
8.5 By Patient Segment
8.6 By Phase

9. Global DLL3 Targeted Drugs Clinical Trials By Company, Indication & Phase

9.1 Research
9.2 Preclinical
9.3 Phase-I
9.4 Phase-I/II
9.5 Phase-II

10. Marketed DLL3 Targeted Drugs Clinical Trials By Company, Indication & Phase

11. DLL3 Targeted Therapies Market Dynamics

11.1 Favorable Market & Clinical Development Parameters
11.2 Challenges & Restraints

12. Key Companies Involved In Research & Development Of DLL3 Targeted Therapies

12.1 Abdera Therapeutics
12.2 Allogene Therapeutics
12.3 Amgen
12.4 Boehringer Ingelheim
12.5 Chugai Pharmaceutical
12.6 Gensun Biopharma
12.7 Harpoon Therapeutics
12.8 ImaginAb Inc
12.9 Legend Biotech
12.10 Molecular Partners
12.11 Phanes Therapeutics
12.12 Qilu Pharmaceutical
12.13 Shanghai Affinity Biopharmaceutical
12.14 ZAI Lab

简介目录图表

List of Figures

Figure 2-1: Antibody Drug Conjugates - Mechanism Of Action
Figure 2-2: BiTE - Amgen
Figure 2-3: HPN328 - Structure
Figure 2-4: Rova-IR700 - Mechanism
Figure 3-1: T-Charge Platform - Features
Figure 3-2: BiTE(R) Antibody Construct
Figure 3-3: TMALIN - ADC Advantages
Figure 3-4: TMALIN - ADC Structure
Figure 3-5: TriTAC - T-Cell Engagers Structure
Figure 3-6: TriTAC - Advantages
Figure 3-7: PACbody(TM) Platform
Figure 3-8: ATACCbody(TM) Platform
Figure 3-9: SPECpair(TM) Platform
Figure 3-10: ROVEr Platform - Process
Figure 3-11: RPT - Advantages
Figure 3-12: Dual-Ig Technology - Antibody Structure & Mechanism
Figure 3-13: AlloCAR T - Process
Figure 3-14: AlloCAR T - Features
Figure 3-15: Alluminox(TM) Platform - Drug Structure
Figure 3-16: Rakuten Medical - Photoimmunotherapy Process
Figure 4-1: Imdelltra - Approval Year By Region
Figure 4-2: US - Price of Supply of Imdelltra Intravenous Powder (US$), January'2025
Figure 4-3: EU - Price Of Imdelltra Intravenous Powder (US$), January'2025:
Figure 4-4: Global - Imdelltra Sales (US$ Million), 2024
Figure 4-5: Imdelltra - Global Sales By Quarter (US$ Million), Q2 & Q3'2024
Figure 4-6: Imdelltra - US Sales (US$ Million), 2024
Figure 4-7: Imdelltra- US Sales By Quarter (US$ Million), Q2 & Q3'2024
Figure 5-1: Global - DLL3 Targeted Therapy Market (US$ Million), 2024
Figure 5-2: Global - DLL3 Targeted Therapy Market Sales (US$ Million), Q2 & Q3'2024
Figure 7-1: DLL3 - Small Cell Lung Cancer
Figure 7-2: DeLLphi-301 Phase 2 Study - Initiation & Completion Year
Figure 7-3: DeLLphi-304 Phase 2 Study - Initiation & Completion Year
Figure 7-4: DAREON(TM)-5 Phase 2 Study - Initiation & Completion Year
Figure 7-5: PT217X1101 Phase 1 Study - Initiation & Completion Year
Figure 7-6: HPN328 Phase 1 Study - Initiation & Completion Year
Figure 7-7: LB2102-1001 Phase 1 Study - Initiation & Completion Year
Figure 7-8: NCT05507593 Phase 1 Study - Initiation & Completion Year
Figure 7-9: DLL3 - Large Cell Neuroendocrine Cancer
Figure 8-1: Global - DLL3 Targeted Drugs Clinical Trials By Company (Number), 2025
Figure 8-2: Global - DLL3 Targeted Drugs Clinical Trials By Fast Track Status (Number), 2025
Figure 8-3: Global - DLL3 Targeted Drugs Clinical Trials By Indication (Number), 2025
Figure 8-4: Global - DLL3 Targeted Drugs Clinical Trials By Location (Number), 2025
Figure 8-5: Global - DLL3 Targeted Drugs Clinical Trials By Patient Segment (Number), 2025
Figure 8-6: Global - DLL3 Targeted Drugs Clinical Trials By Phase (Number), 2025
Figure 11-1: DLL3 Targeted Therapies - Market Drivers & Opportunities
Figure 11-2: DLL3 Targeted Therapies - Market Challenges & Restraints

List of Tables

Table 6-1: US - FDA Designated DLL3 Targeted Therapies, 2025
Table 7-1: Large Cell Neuroendocrine Cancer - Candidates In Clinical Trials, 2025
Table 7-2: Neuroendocrine Prostate Cancer - Candidates In Clinical Trials, 2025
Table 7 3: Gastroenteropancreatic Neuroendocrine Tumors - Candidates In Clinical Trials, 2025
Table 7-4: Glioma - Candidates In Clinical Trials, 2025

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