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癌症分子標靶治療學

市場調查報告書

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1632465

全球 DLL3 標靶治療市場：核准劑量、價格和臨床試驗趨勢（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個工作天內

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簡介目錄圖表

Delta 樣配體 3 (DLL3) 是一種細胞表面蛋白，主要在神經內分泌腫瘤（例如小細胞肺癌 (SCLC)）中表達，但在正常成人組織中表達最少。這種選擇性表達使 DLL3 成為治療選擇有限的惡性癌症的一個有吸引力的治療標靶。透過標靶 DLL3，新型療法可以有效針對腫瘤細胞，同時最大限度地減少對健康組織的損害，符合精準腫瘤學的原則。 2024 年首個針對 DLL3 的療法獲得批准是一個關鍵進展，引發了人們對針對這一獨特生物標記的治療和診斷進展的興趣日益濃厚。

安進公司於 2024 年 5 月批准 Imdeltra (tarlatamab)，這大大改變了 DLL3 標靶治療的格局。 Imdelltra 是第一個針對 DLL3 的治療藥物，代表了腫瘤學領域的顯著進步。雙特異性T細胞接合劑（BiTE）已獲準用於治療接受鉑類化療後病情進展的廣泛期小細胞肺癌（ES-SCLC）成年患者。此加速核准凸顯了其臨床前景，這得益於臨床試驗中觀察到的顯著反應率和反應持續時間（DoR）。然而，持續的驗證試驗對於進一步確定其治療效果至關重要。

從商業角度來看，Imdelltra 取得了令人印象深刻的早期成功，僅在美國市場推出的頭幾個月就實現了超過 4500 萬美元的銷售額。這一早期表現反映了對 ES-SCLC 創新療法的巨大需求，並使 Imdelltra 成為這一發展中治療類別的重要競爭者。 Imdeltra 的商業成功引發了人們對 DLL3 標靶療法的興趣和投資激增，並促成了多項合作和許可協議的達成，各大公司紛紛爭奪這一前景廣闊的市場的佔有率。

本報告研究了全球 DLL3 標靶治療市場，並概述了市場以及藥物趨勢、臨床試驗趨勢、區域趨勢以及進入市場的公司的競爭格局。

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

簡介目錄圖表

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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