Zai Lab to Present Phase 1 Data on DLL3-Targeted ADC ZL-1310 at ASCO 2025
Zai Lab Limited , a leading innovative biopharmaceutical company, announced today that it will present updated clinical data from its ongoing global Phase 1a/1b study evaluating ZL-1310, a Delta-like ligand 3 (DLL3) targeting antibody-drug conjugate (ADC), at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The event is set to take place from May 30 to June 3, 2025, at McCormick Place Convention Center in Chicago, Illinois.
ZL-1310 is Zai Lab’s investigational ADC designed for the treatment of extensive-stage small cell lung cancer (ES-SCLC). It is currently being evaluated in patients who have previously received at least one platinum-based chemotherapy regimen. The updated results from the clinical trial, registered under NCT06179069, will include data from additional patients and extended follow-up, offering a more comprehensive understanding of ZL-1310’s clinical potential in a population with high unmet medical need.
A First- and Best-in-Class Candidate Targeting DLL3 in SCLC
ZL-1310 is engineered to selectively target DLL3, a protein aberrantly expressed on the surface of small cell lung cancer cells but largely absent in normal adult tissues. DLL3 has emerged as a promising target in SCLC, a particularly aggressive and fast-growing form of lung cancer that accounts for about 10-15% of all lung cancer diagnoses. Unlike non-small cell lung cancer (NSCLC), SCLC is characterized by rapid proliferation, early metastasis, and limited therapeutic options, especially in the relapsed or refractory setting.
Historically, patients with ES-SCLC have had limited treatment options beyond first-line chemotherapy, typically platinum-etoposide regimens. While recent years have seen the introduction of immunotherapy agents, including PD-L1 inhibitors such as atezolizumab and durvalumab, the prognosis remains grim, with five-year survival rates often falling below 5%.
In this therapeutic context, ZL-1310 has the potential to be a transformative treatment. By targeting DLL3, the ADC can deliver a potent cytotoxic payload directly to tumor cells while sparing normal tissue, potentially enhancing antitumor activity while minimizing systemic toxicity.
“ZL-1310 reflects our company’s commitment to develop differentiated oncology therapies that address current limitations with many first-generation and standard-of-care treatments,” said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. “We believe that targeting DLL3 with a highly specific ADC has the potential to redefine outcomes for patients with extensive-stage small cell lung cancer. We are excited to share the latest findings from our ongoing clinical program at ASCO 2025.”
ASCO 2025 Presentation and Key Details
The updated ZL-1310 results will be featured in a dedicated poster session within the “Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology” track, underscoring the novel mechanism and first-in-class aspirations of the drug.
Poster Presentation Details:
- Title: ZL-1310, a DLL3 ADC, in patients with extensive-stage small cell lung cancer: Phase 1 trial update
- Presenter: Dr. Manish R. Patel, Florida Cancer Specialists / Sarah Cannon Research Institute, Sarasota, FL
- Session Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
- Date & Time: Monday, June 2, 2025, from 1:30 p.m. to 4:30 p.m. CT
- Location: McCormick Place Convention Center, Hall A – Posters and Exhibits
- Abstract Number: 3041
- Poster Board: 356
The poster is expected to highlight updated safety and efficacy data from the trial, including response rates, duration of response, progression-free survival (PFS), overall survival (OS), and adverse event profiles. Preliminary data from earlier stages of the trial hinted at encouraging antitumor activity and manageable safety, particularly in heavily pretreated patient cohorts.
Zai Lab Investor Webcast and Strategy Update
To coincide with the ASCO presentation, Zai Lab will also host an investor-focused conference call and live webcast. The session will offer additional context surrounding the ZL-1310 trial data and provide insights into the company’s future development plans for the program, including potential next steps toward registration-directed trials.
The investor session will not only review the clinical results but also delve into the strategic significance of ZL-1310 within Zai Lab’s oncology pipeline, which includes multiple assets across solid tumors and hematological malignancies. With a focus on targeted therapies and novel mechanisms of action, Zai Lab has positioned itself as a nimble yet globally relevant innovator in the oncology space.
Strategic Significance and Global Development Plans
The development of ZL-1310 is emblematic of Zai Lab’s broader strategic vision to build a globally competitive portfolio anchored in scientific innovation, translational research, and strategic partnerships. As the company advances ZL-1310 through clinical development, it continues to leverage its dual-platform presence in China and the U.S. to accelerate global registration timelines.
With its robust R&D infrastructure and collaborations with leading research institutions, Zai Lab is uniquely positioned to bring cutting-edge therapies like ZL-1310 to patients faster and more efficiently than traditional large pharma players.
In parallel with advancing ZL-1310, the company is also evaluating potential expansion of the DLL3-targeting platform into other DLL3-expressing tumors, such as neuroendocrine carcinomas and other rare thoracic malignancies.
As Zai Lab prepares to share these critical updates at one of the most prestigious oncology gatherings in the world, the oncology community is watching closely. With its differentiated mechanism, early clinical activity, and strong biological rationale, ZL-1310 could offer renewed hope for patients with ES-SCLC—a population historically underserved by therapeutic innovation.
The ASCO 2025 presentation will mark a significant milestone in the clinical development of ZL-1310 and may help shape the next phase of treatment paradigms in small cell lung cancer.
For investors, clinicians, and patients alike, all eyes will be on Zai Lab’s poster board 356 come June 2. If the data continues to show promise, ZL-1310 could represent not just a new therapeutic option, but a new era in targeted treatment for aggressive lung cancers.
