zocilurtatug pelitecan (ZL-1310) / ZAI Lab, MediLink - LARVOL DELTA

Expected Clinical Developments and Data Readouts:…Zocilurtatug Pelitecan (zoci, DLL3 ADC) (formerly ZL-1310) (Businesswire) - "(i) Second-Line+ ES-SCLC: Zai Lab to present updated data on intracranial activity from the ongoing Phase 1 study in the first half of 2026; (ii) First-Line ES-SCLC: Zai Lab to provide data readout from the Phase 1 study evaluating zoci combination therapy (with atezolizumab and/or chemotherapy) in the first half of 2026 and advance into a registrational study in 2026 based on emerging data. Zai Lab also plans to initiate a Phase 1 study to explore zoci in a novel combination in 2026; (iii) Other neuroendocrine carcinomas: Zai Lab to provide data readout from the global Phase 1/2 study in patients with selected solid tumors in the first half of 2026 and advance into a registrational-enabling cohort in 2026."

Clinical data • New trial • Neuroendocrine Carcinoma • Small Cell Lung Cancer

Phase 1 trial of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer (AACR-NCI-EORTC 2025) - P1 | "All pts had prior platinum-based chemotherapy, of whom 90.4% received a prior anti-PD‑L1, 13 (12.5%) had prior lurbinectedin, and 10 (9.6%) had a prior DLL3-targeted therapy. ZL-1310 has a manageable safety profile, encouraging activity, and displayed meaningful improvements in pts with CNS disease, addressing a critical unmet need – including in those with asymptomatic, untreated brain metastases. These data support further clinical development of ZL-1310 in SCLC."

Clinical • Late-breaking abstract • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Trial in progress: A Phase Ib/II, Open-label, Multi-center Study of ZL-1310 in Participants with DLL3 positive Neuroendocrine Carcinomas (NECs) and other Selected Solid Tumors (NANETS 2025) - "Platinum-based chemotherapy, using either cisplatin or carboplatin plus etoposide, is recommended as the first-line therapy for advanced and metastatic disease. Tumor response will be assessed every 6 weeks relative to the first dose of ZL-1310 for the first 30 weeks and every 9 weeks thereafter until disease progression by RECIST v1.1. RESULTS N/A CONCLUSIONS N/A"

Clinical • P1/2 data • Endocrine Cancer • Genito-urinary Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3 • EGFR

Phase 1 trial of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer (AACR-NCI-EORTC 2025) - P1 | "All pts had prior platinum-based chemotherapy, of whom 90.4% received a prior anti-PD‑L1, 13 (12.5%) had prior lurbinectedin, and 10 (9.6%) had a prior DLL3-targeted therapy. ZL-1310 has a manageable safety profile, encouraging activity, and displayed meaningful improvements in pts with CNS disease, addressing a critical unmet need – including in those with asymptomatic, untreated brain metastases. These data support further clinical development of ZL-1310 in SCLC."

Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=665 | Not yet recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd.

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Zai Lab Announces…Initiation of Global Phase 3 Registrational Study (Businesswire) - "The Phase 3 registrational clinical trial of zoci is a multicenter study that will enroll approximately 665 patients globally, including in North America, Asia, and Europe....First-line SCLC and neuroendocrine carcinoma programs advancing toward registrational phase in 2026."

New trial • Trial status • Neuroendocrine Carcinoma • Small Cell Lung Cancer

Zai Lab Announces Updated Phase 1 Data for Zocilurtatug Pelitecan (formerly ZL-1310), Demonstrating Potential as a First-in-Class/Best-in-Class DLL3-Targeted ADC for Small Cell Lung Cancer… (Businesswire) - "Robust responses observed in heavily pre-treated patients with a 68% ORR for 1.6 mg/kg in second-line setting.Compelling activity in patients with baseline brain metastases (n=32), including an 80% ORR for patients without prior brain radiotherapy. Duration of response of 6.1 months across all doses and all lines of therapy; enrollment continuing for 1.2 mg/kg and 1.6 mg/kg, with nearly half of responders ongoing at data cut-off....This data will be presented as an oral presentation and was included as part of the press program at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics..."

P1 data • Small Cell Lung Cancer

Zai Lab Limited…announced that a late-breaking abstract (LBA) featuring new data from its global Phase 1 clinical trial (NCT06179069) evaluating zocilurtatug pelitecan (zoci)…has been selected for an oral presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Businesswire) - "Oral presentation to feature new data highlighting the potential of zocilurtatug pelitecan (formerly called ZL-1310)...for patients with extensive-stage small cell lung cancer (ES-SCLC)."

Late-breaking abstract • P1 data • Small Cell Lung Cancer

Zai Lab Announces Second Quarter 2025 Financial Results and Recent Corporate Updates (Businesswire) - "ZL-1310 or Zocilurtatug pelitecan (DLL3 ADC) - Second-Line ES-SCLC: Zai Lab to provide data update and to initiate a global registrational study of ZL-1310 monotherapy in the second half of 2025. First-Line ES-SCLC: Zai Lab to provide data readout for dose escalation of ZL-1310 doublet in combination with atezolizumab. Other neuroendocrine carcinomas: Zai Lab to provide data readout from the global Phase 1/2 study in patients with selected solid tumors."

New trial • P1 data • P1/2 data • Neuroendocrine Carcinoma • Small Cell Lung Cancer • Solid Tumor

Redefining the Fight Against SCLC: Standards, Innovations, and New Horizons. (PubMed, Cancers (Basel)) - "Despite multimodal standard therapies, most patients relapse within months, and second-line treatment options such as topotecan offer only limited benefit... Emerging treatment strategies include bispecific T-cell engagers (e.g., tarlatamab), antibody-drug conjugates (ADCs) such as sacituzumab govitecan, DS-7300, and ZL-1310, as well as targeted therapies...The clinical implementation of molecular subtyping remains limited, though it holds promise for future personalized treatment approaches. Despite recent progress, SCLC continues to pose substantial therapeutic challenges, emphasizing the need for improved treatment strategies and validated predictive biomarkers."

Journal • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of ZL-1310 in Participants With Selected Solid Tumors (clinicaltrials.gov) - P1/2 | N=86 | Recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

ZL-1310, a DLL3 ADC, in patients with extensive stage small cell lung cancer: Ph1 trial update. (ASCO 2025) - P1 | "ZL-1310 demonstrated a tolerable safety profile and promising antitumor activity in r/r ES-SCLC, including pts with brain metastases, pt with prior tarlatamab, and in the setting of low DLL3 expression. Updated data, including patients in the randomized Part 2 dose optimization, will be presented."

Clinical • IO biomarker • Anemia • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • DLL3

ZL-1310: “ZL-1310 demonstrated an acceptable safety profile with low rates of drug withdrawal and low-rates of high grade adverse events”; Small cell lung cancer (Zai Lab) - ASCO 2025: “ZL-1310 presented encouraging anti-tumor activity in patients with relapsed or recurrent ES-SCLC, including those with brain metastases”

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer

Zai Lab Presents Positive Phase 1 Data for ZL-1310, a DLL3-Targeted ADC, Demonstrating Robust Anti-Tumor Activity and Safety in Patients with Extensive-Stage Small Cell Lung Cancer at 2025 ASCO Annual Meeting (Zai Lab Press Release) - P1a/1b | N=112 | NCT06179069 | Sponsor: Zai Lab (Shanghai) Co., Ltd. | "Clinically meaningful anti-tumor activity of ZL-1310 observed in heavily pretreated population of patients with small cell lung cancer (SCLC) across dose escalation and expansion cohorts; In second-line (2L) SCLC, objective response rate (ORR) was 67% across all dose levels (n=33) and 79% at 1.6 mg/kg dose (n=14); Median duration of response has not yet been reached, with 29 of 38 responders remaining on study; 27 of 31 patients with stable disease remaining on study, the majority of whom had tumor regressions; ZL-1310 demonstrated a well-tolerated safety profile at target doses of less than 2.0 mg/kg, with Grade ≥3 treatment-related adverse events (TRAEs) of 6%, and no drug discontinuations; Company plans to initiate pivotal trial in 2L SCLC with selected optimal dose later this year."

New P2 trial • P1 data • Small Cell Lung Cancer

ZL-1310: Regulatory filing in US for 2L SCLC in H2 2026 (Zai Lab) - ASCO 2025: Regulatory approval in US for 2L SCLC in H2 2027

FDA approval • FDA filing • Lung Cancer • Oncology • Small Cell Lung Cancer

ZL-1310: Data from P1 trial (NCT06179069) in combination with atezolizumab for 1L SCLC by end of 2025 (Zai Lab) - ASCO 2025

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer

Zai Lab Receives U.S. FDA Fast Track Designation for ZL-1310, a DLL3-Targeted Antibody-Drug Conjugate, for Treatment of Extensive-Stage Small Cell Lung Cancer (Gurufocus) - "Zai Lab Limited (ZLAB, Financial) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its novel Delta-like ligand (DLL3) antibody-drug conjugate, ZL-1310, for treating extensive-stage small cell lung cancer (ES-SCLC)."

Fast track • Small Cell Lung Cancer

Zai Lab to Present Data from Phase 1 Trial of DLL3-Targeted Antibody-Drug Conjugate (ADC) ZL-1310 at 2025 ASCO Annual Meeting (Businesswire) - "Zai Lab Limited...announced that updated data from an ongoing, global Phase 1a/1b clinical trial (NCT06179069) evaluating ZL-1310, the Company’s potential first-in-class and best-in-class, Delta-like ligand (DLL3) antibody-drug conjugate (ADC) for the treatment of extensive-stage small cell lung cancer (ES-SCLC), will be presented during a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3, 2025 in Chicago, Illinois. The updated results will include additional patients and follow-up from the ongoing trial of ZL-1310 in patients with previously treated ES-SCLC after at least one prior platinum-based chemotherapy regimen."

P1 data • Small Cell Lung Cancer

A Phase Ib/II, Open-label, Multi-center Study of ZL-1310 in Participants with Selected Solid Tumors (clinicaltrials.gov) - P1/2 | N=86 | Not yet recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd.

New P1/2 trial • Neuroendocrine Tumor • Oncology • Solid Tumor

ZL-1310: Initiation of P3 trial for SCLC in 2025 (Zai Lab) - Q4 2024 Results

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer

Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC) (Businesswire) - "Zai Lab Limited...today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC)."

Orphan drug • Small Cell Lung Cancer

ZL-1310-001: A Study of ZL-1310 in Subjects With Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | Trial completion date: Dec 2027 ➔ Jul 2027

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

ZL-1310: Initiation of P1 trial for neuroendocrine tumors in 2025 (Zai Lab) - Corporate Presentation

New P1 trial • Neuroendocrine Tumor • Oncology

DLL3-Targeted ADC Produces Responses in Previously Treated ES-SCLC (Cancer Network) - "'The preliminary results from the ongoing phase 1 trial of ZL-1310 suggest that this next-generation ADC therapy has the potential to deliver anti-tumor responses in the majority of patients with ES-SCLC, with good tolerability,' Alexander Spira MD, PhD...stated in the press release. 'This is particularly encouraging given the urgent need for improved treatment options for these patients. These promising data support continued evaluation of ZL-1310 as a monotherapy in the dose-expansion phase of the ongoing phase 1 clinical trial and in combination.'"

Media quote

Preliminary Results from a Phase Ia/Ib, Open-label, Multicenter Study of ZL-1310, a DLL3-targeted ADC, to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer - NCT06179069 (EORTC-NCI-AACR 2024) - P1 | "Preliminary results demonstrated ZL-1310 has a favorable PK and safety profile, with evidence of early clinical activity observed at the first dose level. The data support the continued dose escalation in SCLC and will be updated at presentation"

Clinical • P1 data • PK/PD data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3