델타 유사 리간드 3(DLL3)은 소세포폐암(SCLC)과 같은 신경내분비 종양에서 우세하게 발현되는 반면, 정상 성인 조직에서는 최소한의 발현만을 보이는 세포 표면 단백질입니다. 이러한 선택적 발현으로 인해 DLL3는 치료 옵션이 제한적인 공격적인 암의 매력적인 치료 표적이 될 수 있으며, DLL3를 표적으로 삼는 새로운 치료제는 종양 세포를 효과적으로 표적으로 삼으면서도 건강한 조직 손상을 줄일 수 있으며, 정밀 종양학의 원칙에 부합하는 치료법입니다. 2024년 DLL3를 표적으로 하는 첫 번째 치료제가 승인된 것은 매우 중요한 발전이며, 이 특징적인 바이오마커에 초점을 맞춘 치료와 진단의 발전에 대한 관심을 불러일으키고 있습니다.
2024년 5월 암젠의 임델트라(성분명: 탈라라타맙)의 승인은 DLL3를 표적으로 하는 치료제의 전망을 크게 바꾸고 있으며, DLL3를 표적으로 하는 첫 번째 치료제인 임델트라는 종양학 분야에서 놀라운 진전을 의미합니다. 이 이중특이성 T세포 엔게이저(BiTE)는 백금 기반 화학요법 후 병이 진행된 광범위 소세포폐암(ES-SCLC) 성인 환자를 대상으로 승인을 받았습니다. 임상시험에서 관찰된 우수한 반응률과 반응 기간(DoR)에 힘입어 이번 조기 승인은 BiTE의 임상적 잠재력을 강조하고 있습니다. 그러나 치료 효과를 입증하기 위해서는 현재 진행 중인 확인 임상시험이 필수적입니다.
상업적 측면에서 임델트라는 출시 후 몇 달 만에 미국 시장에서만 4,500만 달러 이상의 매출을 달성하는 등 초기 성공을 거두고 있습니다. 이러한 초기 성과는 ES-SCLC의 혁신적 치료에 대한 큰 수요를 반영하고 있으며, 임델트라를 이 개발중인 치료 분야에서 중요한 경쟁 약물로 자리매김하고 있습니다. 임델트라의 상업적 성공은 DLL3 표적치료제에 대한 관심과 투자가 급증하고 있으며, 주요 기업이 이 유망한 시장에서 경쟁하고 있는 가운데 많은 제휴 및 라이선스 계약이 이루어지고 있습니다.
세계의 DLL3 표적 치료제 시장에 대해 조사했으며, 시장의 개요와 약제 동향, 임상시험 동향, 지역별 동향 및 시장에 참여하는 기업의 경쟁 구도 등을 제공하고 있습니다.
Global DLL3 Targeted Therapies Market, Approved Drugs Dosage, Pricing & Clinical Trials Insight 2025 Report Finding and Highlights:
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.