Zai Lab to Present Phase 1 Data on Novel DLL3-Targeted ADC for Small Cell Lung Cancer at ASCO 2025
核心洞察
Zai Lab will showcase updated results from its Phase 1a/1b trial of ZL-1310, a potentially best-in-class DLL3 (搜索)-targeted antibody-drug conjugate for extensive-stage small cell lung cancer (搜索) at the 2025 ASCO (搜索) Annual Meeting.
The novel ADC utilizes TMALIN® technology platform to overcome limitations of first-generation ADCs by leveraging the tumor microenvironment, with the FDA granting Orphan Drug Designation in January 2025.
ZL-1310 combines a humanized anti-DLL3 (搜索) monoclonal antibody with a novel camptothecin derivative payload, targeting an antigen overexpressed in aggressive neuroendocrine tumors associated with poor outcomes.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced today that it will present updated data from its ongoing global Phase 1a/1b clinical trial of ZL-1310 at the upcoming American Society of Clinical Oncology (ASCO (搜索)) Annual Meeting in Chicago from May 30-June 3, 2025. ZL-1310 is the company's Delta-like ligand 3 (搜索) (DLL3 (搜索)) targeted antibody-drug conjugate (ADC) being developed for extensive-stage small cell lung cancer (搜索) (ES-SCLC (搜索)).
The presentation will include expanded patient data and additional follow-up from the ongoing trial (NCT06179069) evaluating ZL-1310 in patients with previously treated ES-SCLC (搜索) who have received at least one prior platinum-based chemotherapy regimen.
Novel Approach to Aggressive Lung Cancer
Small cell lung cancer (搜索) represents approximately 15% of the 2.5 million lung cancer diagnoses worldwide annually, with two-thirds of patients diagnosed at extensive stage. The disease is known for its aggressive nature and poor prognosis, creating a significant unmet medical need.
"ZL-1310 reflects our company's commitment to develop differentiated oncology therapies that address current limitations with many first-generation and current standard-of-care treatments," said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. "We are focused on the development of ZL-1310, and we look forward to presenting updated results at ASCO (搜索) 2025."
Innovative ADC Technology
ZL-1310 targets DLL3 (搜索), an antigen overexpressed in many neuroendocrine tumors, including SCLC, that is often associated with poor clinical outcomes. The compound's design incorporates several advanced features:
- A humanized anti-DLL3 monoclonal antibody
- A cleavable linker
- A novel camptothecin derivative (topoisomerase 1 inhibitor) payload
- Integration with the proprietary TMALIN® technology platform
The TMALIN® platform leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, potentially offering improved efficacy and safety profiles.
The U.S. Food and Drug Administration (FDA) recognized ZL-1310's potential by granting it Orphan Drug Designation in January 2025 for the treatment of SCLC.
Presentation Details
The poster presentation, titled "ZL-1310, a DLL3 (搜索) ADC, in patients with extensive stage small cell lung cancer (搜索): Ph1 trial update," will be presented by Dr. Manish R. Patel of Florida Cancer Specialists/Sarah Cannon Research Institute during the Developmental Therapeutics - Molecularly Targeted Agents and Tumor Biology poster session on Monday, June 2, 2025, from 1:30 p.m. to 4:30 p.m. CT at McCormick Place Convention Center.
Zai Lab will also host an investor conference call and webcast on the same day at 7:00 a.m. CT / 8:00 a.m. ET / 8:00 p.m. HKT to discuss the updated data and outline next steps in the clinical development program. Dr. Rafael G. Amado will lead the presentation.
About Zai Lab
Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company with dual headquarters in Shanghai, China, and Cambridge, Massachusetts. The company focuses on discovering, developing, and commercializing innovative products addressing significant unmet medical needs in oncology, immunology, neuroscience, and infectious disease.
The company's approach to ZL-1310 development aligns with its broader mission to leverage its expertise and resources to positively impact human health worldwide, particularly in areas with high unmet needs like aggressive cancers such as SCLC.
As the development of ZL-1310 progresses, the biopharmaceutical industry will be watching closely to see if this novel ADC can deliver on its promise to improve outcomes for patients with limited treatment options. The upcoming data presentation at ASCO (搜索) 2025 represents an important milestone in evaluating the potential of this innovative therapy.