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

ZL 1310 (DLL3 ADC) plus Atezolizumab ± Carboplatin in extensive-stage small cell lung cancer: Part 1b/1c results from Study ZL 1310 001 (ESMO 2026) - No abstract available

ADC • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

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

Preliminary results from the phase 1b/2, open-label, multi-center study of ZL-1310, a DLL3-targeted ADC, in patients with neuroendocrine carcinomas and other selected solid tumors (AACR 2026) - P1/2 | "ZL-1310 dosed at 1.6mg/kg Q3W is well tolerated. The AE profile observed in pts with NEC is generally consistent with that of SCLC from a larger study. The preliminary efficacy results are encouraging in this patient population with a high unmet need following platinum-based chemotherapy."

ADC • Clinical • P1/2 data • Bladder Cancer • Endocrine Cancer • Genito-urinary Cancer • Genitourinary Neuroendocrine Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

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

Zocilurtatug pelitecan: FDA submission for 2L/3L SCLC (based on DLLEVATE trial) in 2027 (Zai Lab) - Corporate Presentation

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

A Study of ZL-1310 in Combination With a Checkpoint Inhibitor Versus Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=530 | Not yet recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd.

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

Expected Clinical Developments and Data Readouts - Zocilurtatug Pelitecan…: epNECs (Businesswire) - "Complete enrollment in the Phase 2 expansion portion of the ongoing global Phase 1b/2 study evaluating zoci in patients with selected solid tumors and, subject to regulatory feedback, advance the program into registrational development in the second half of 2026."

Enrollment status • Pipeline update • Neuroendocrine Carcinoma • Solid Tumor

Expected Clinical Developments and Data Readouts - Zocilurtatug Pelitecan…: Second-Line Plus ES-SCLC (Businesswire) - "Complete enrollment in the global pivotal Phase 3 DLLEVATE study in the first half of 2027 followed by a planned interim analysis with the potential to support a BLA submission for accelerated approval."

Enrollment status • P3 data • Small Cell Lung Cancer

Expected Clinical Developments and Data Readouts - Zocilurtatug Pelitecan…: First-Line Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (Businesswire) - "Report initial Phase 1 data evaluating zoci in combination with atezolizumab, with or without chemotherapy, at the European Society for Medical Oncology (ESMO) 2026 Congress in October 2026 and, subject to emerging data and regulatory discussions, initiate a registrational Phase 3 study in the second half of 2026."

New P3 trial • P1 data • Small Cell Lung Cancer

U.S. FDA Grants Orphan Drug Designation to Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan (Zoci) for the Treatment of Neuroendocrine Carcinomas (NECs) (Businesswire)

Orphan drug • Neuroendocrine Carcinoma

A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1/2 trial • Endocrine Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

A Study of ZL-1310 in Participants With Selected Solid Tumors (clinicaltrials.gov) - P1/2 | N=112 | Recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | N=86 ➔ 112 | Trial completion date: Jun 2027 ➔ Dec 2027 | Trial primary completion date: Dec 2026 ➔ Aug 2027

Enrollment change • Trial completion date • Trial primary completion date • 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

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

The European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), for the treatment of pulmonary neuroendocrine carcinomas (NECs) (StockTitan.net) - "In granting the designation, the COMP noted that preliminary clinical data in patients with relapsed or refractory extensive-stage SCLC suggest zoci may offer a more favorable effect than currently authorized therapies, including durable responses, a finding the Committee characterized as a clinically relevant advantage."

European regulatory • Orphan drug • Lung Neuroendocrine Carcinoma • Small Cell Lung Cancer

ZL-1310-003: A Study to Test How Well ZL-1310 may Work Compared to Therapies Selected by the Investigator in Treating Patients with Relapsed Small Cell Lung Cancer (clinicaltrialsregister.eu) - P2/3 | N=131 | Not yet recruiting | Sponsor: Zai Lab (US) LLC

New P2/3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Zocilurtatug pelitecan: "Overall confirmed intracranial objective response rate (iORR) was 53.7%; at 1.6 mg/kg, the iORR was 62.5%"; Small Cell Lung Cancer (Zai Lab) - AACR 2026: "7 complete responses across all doses (CR rate: 17.1%, 7/41), including 4 CRs with 1.6 mg/kg (CR rate: 25.0%, 4/16)"

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

A randomized, open-label, phase 3 study of ZL-1310, a DLL3 antibody-drug conjugate (ADC), compared to investigator's choice therapy in participants with relapsed small cell lung cancer (DLLEVATE). (ASCO 2026) - P3 | "This multi-country Phase III study (NCT07218146) enrolls adults with Extensive Stage (ES)-SCLC patients (pts) who have progressed after platinum-based first-line (1L) therapy or after tarlatamab as second-line (2L) therapy. The study has one interim analysis based on Objective Response Rate (ORR) assessed by Blind Independent Review Committee (BIRC) and the primary analysis based on Overall Survival (OS). Enrollment is underway, and is planned at ~250 sites across several continents."

ADC • Clinical • P3 data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Zai Lab Receives U.S. FDA Fast Track Designation for Zocilurtatug Pelitecan (Zoci), a DLL3-Targeting ADC, for Treatment of Extrapulmonary Neuroendocrine Carcinomas (epNECs) (Businesswire) - "Zai Lab reported promising preliminary data from an ongoing registration-enabling multicenter, Phase 1b/2 clinical trial of zoci (NCT06885281) in patients with epNEC and other selected solid tumors at the American Association for Cancer Research (AACR) Annual Meeting 2026 last month."

Fast track • Neuroendocrine Carcinoma

Addressing Unmet Needs in the Management of Small Cell Lung Cancer: Treatment of Brain Metastases, Quality of Life, and the Role of Real-World Evidence. (PubMed, Curr Treat Options Oncol) - "Emerging therapies, such as antibody-drug conjugates targeting B7-H3/DLL3 (I-Dxd, ZL-1310) and bispecific antibody tarlatamab, have demonstrated intracranial response rates of 62.5%-71%. Future directions involve developing new drugs with high blood-brain barrier penetration, such as radioligand therapy, conducting prospective studies to optimize HA and SRS applications, establishing high-quality RWE databases to support personalized treatments, exploring molecular subtypes (SCLC-A/N/P/I) and leveraging AI technologies to advance precision radiotherapy. SCLC management needs to be patient-centered, integrating precise treatment of brain metastases, QoL improvement, and the application of RWE to achieve a balance between survival benefits and QoL."

HEOR • Journal • Real-world evidence • Review • Cough • Lung Cancer • Neuroendocrine Tumor • Oncology • Palliative care • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • DLL3

Zocilurtatug pelitecan (zoci) (Zai Lab Press Release) - "Registrational DLLEVATE trial ongoing with enrollment expected to complete in the first half of 2027"

Enrollment status • Lung Neuroendocrine Carcinoma • Small Cell Lung Cancer

DeLLphi-313: Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

20250114: Phase 1b Study of Tarlatamab + ZL-1310 +/- Anti-PD-L1 in Small Cell Lung Cancer (clinicaltrialsregister.eu) - P1 | N=11 | Not yet recruiting | Sponsor: Amgen Inc.

New P1 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

ZL-1310-001: A Study of ZL-1310 in Subjects With Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=339 | Recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | N=112 ➔ 339

Enrollment change • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Intracranial activity of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer and baseline brain metastasis: Analysis of a phase 1 trial (AACR 2026) - P1 | "A total of 94 (90.4%) received a prior anti-PD‑L1, 13 (12.5%) had prior lurbinectedin, and 10 (9.6%) had prior DLL3-targeted therapy. ZL-1310 is well tolerated and demonstrated encouraging systemic efficacy in heavily pretreated ES-SCLC with BM. The preliminary independent assessment also showed ZL-1310 has high intracranial efficacy including in patients with untreated BM."

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