Verizon (opamtistomig) / Leads Biolabs - LARVOL DELTA

Phase II Study of Opamtistomig (LBL-024), a PD-L1/4-1BB Bispecific Antibody Plus Chemotherapy in First-Line Advanced NSCLC (IASLC-WCLC 2026) - P2 | "The nsqNSCLC cohort received Opamtistomig (15 mg/kg) plus pemetrexed and carboplatin Q3W for 4-6 cycles, followed by maintenance with Opamtistomig plus pemetrexed. The sqNSCLC cohort received Opamtistomig plus paclitaxel and carboplatin Q3W, followed by Opamtistomig maintenance...While follow-up is limited, these results support further evaluation and suggest its novel mechanism could help define a new treatment approach in cancer immunotherapy. Updated results will be presented at WCLC 2026."

Bispecific • Clinical • Metastases • P2 data • Leukopenia • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor

Opamtistomig (LBL-024), a novel PD-L1×4-1BB bispecific antibody, combined with chemotherapy as first-line treatment for advanced extrapulmonary neuroendocrine carcinoma: results from a phase Ib/II trial (ESMO 2026) - No abstract available

Bispecific • Clinical • Metastases • P1/2 data • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Leads Biolabs' PD-L1/4-1BB Bispecific Antibody Opamtistomig (LBL-024) Granted Orphan Drug Designation in Japan, Further Expanding Global Regulatory Recognition (GlobeNewswire)

Orphan drug • Neuroendocrine Carcinoma

Efficacy of systemic therapies across lines in EP-NEC: Meta-analysis with contextualization of opamtistomig (LBL-024) (ESMO 2026) - No abstract available

Retrospective data • Oncology

Promising preliminary phase II clinical activity of opamtistomig (LBL-024), a PD-L1×4-1BB bispecific antibody, plus gemcitabine–cisplatin in first-line advanced biliary tract cancer (ESMO 2026) - No abstract available

Bispecific • Clinical • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Efficacy evaluation and mechanistic validation of opamtistomig (LBL-024), a PD-L1×4-1BB bispecific antibody in immunologically cold MSS colorectal cancer (ESMO 2026) - No abstract available

Bispecific • Clinical • Colorectal Cancer • Oncology • Solid Tumor

Opamtistomig (LBL-024) monotherapy in advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC) after ≥2 prior lines of therapies: results from a pivotal, registrational phase IIb study of a novel PD-L1×4-1BB bispecific antibody (ESMO 2026) - No abstract available

Bispecific • Late-breaking abstract • Metastases • Monotherapy • P2b data • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology

A Clinical Trial of LBL-024 Combination Drug in Patients With Metastatic Colorectal Carcinoma (clinicaltrials.gov) - P1/2 | N=369 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor

Assessment of efficacy of LBL-024, a novel and uniquely designed bispecific antibody against PD-L1 and 4-1BB, combined with etoposide/platinum-based chemotherapy in treatment-naive advanced extrapulmonary neuroendocrine carcinoma (EP-NEC): A multicenter phase Ib/II trial. (ASCO 2025) - P1/2 | "Here we report the safety and efficacy of LBL-024 combined with etoposide and cisplatin or carboplatin (EP/EC) as first line treatment in patients with advanced NEC. LBL-024 combined with chemotherapy was well-tolerated. The extremely improved response observed in EP-NECs is significantly higher than the historic reports (about 30%~55%). Data including ER analysis of this ongoing study will be updated by a follow-up submission to ASCO."

Clinical • Metastases • P1/2 data • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • PD-L1

Leads Biolabs’ Pivotal Phase IIb Study of Opamtistomig (LBL-024) in Advanced EP-NEC Selected as ESMO 2026 Late-Breaking Abstract; Three Studies Selected for Proffered Paper Presentations (GlobeNewswire) - "The pivotal, registrational Phase IIb study is evaluating the efficacy and safety of opamtistomig monotherapy in patients with advanced EP-NEC who have received at least two prior lines of systemic therapy....In addition to the EP-NEC pivotal study, two other Leads Biolabs studies have been selected for Proffered Paper presentations at ESMO 2026...: (i) A Phase Ib/II study of opamtistomig in combination with chemotherapy as first-line treatment for advanced EP-NEC; and (ii) A Phase I study of LBL-034 in patients with relapsed/refractory multiple myeloma (RRMM)."

Late-breaking abstract • P1 data • P1/2 data • P2b data • Multiple Myeloma • Neuroendocrine Carcinoma

WCLC 2026 | Leads Biolabs’ Opamtistomig (LBL-024) Oral Presentation Demonstrates Robust Response and PFS Benefits in First‑Line NSCLC (GlobeNewswire) - "As of July 1, 2026, 63 treatment-naïve patients had been enrolled, including 31 non-squamous and 32 squamous NSCLC patients. More than 90% had stage IV disease, and a considerable proportion had multiple metastases, including brain and liver metastases. PD-L1 TPS ≥1% was observed in only 35.5% of non-squamous and 43.8% of squamous patients, well below the 60%–70% in the general NSCLC population. Median follow-up was 7.1 months. Among 62 efficacy-evaluable patients, ORR was 71.0%, DCR was 95.2%, and the 6-month PFS rate was 70.6%."

P2 data • Non Small Cell Lung Cancer

Leads Biolabs’ Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Abstract Published by WCLC: Extended Follow‑Up Shows Continued Efficacy Improvement (GlobeNewswire) - "Based on data analyzed as of March 6, 2026, LBL-024 in combination with chemotherapy demonstrated an encouraging antitumor activity in the overall population, with robust tumor shrinkage observed in both the squamous and non-squamous NSCLC. The abstract data were based on a median follow‑up of 3.6 months. Updated data with over 7 months of follow‑up will be presented in an oral presentation at WCLC on September 14, 2026. According to the abstract, among 60 efficacy-evaluable patients with locally advanced or metastatic NSCLC who received LBL-024 in combination with chemotherapy as first-line treatment, the objective response rate (ORR) was 65.0% and the disease control rate ('DCR') was 95.0%. In the squamous subgroup, the ORR was 77.4% and the DCR was 96.8%, while in the non-squamous subgroup, the ORR was 51.7% and the DCR was 93.1%."

P2 data • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer

Nanjing Leads Biolabs…announced that Opamtistomig (LBL-024), the Company’s proprietary PD-L1/4-1BB bispecific antibody, as a first-line treatment for locally advanced or metastatic esophageal squamous cell carcinoma (ESCC), has completed its safety run‑in assessment and advanced to the expansion phase based on encouraging efficacy signals and a favorable safety profile (GlobeNewswire) - "This expansion phase is designed as a randomized controlled trial to conduct a head‑to‑head comparison of Opamtistomig plus chemotherapy versus tislelizumab plus chemotherapy as first‑line therapy for ESCC, aiming to further improve clinical outcomes over the current standard of care."

Trial status • Esophageal Squamous Cell Carcinoma

Nanjing Leads Biolabs Co., Ltd...announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Opamtistomig (LBL-024), the Company's proprietary PD-L1/4-1BB bispecific antibody, as a monotherapy for the treatment of previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). (PRNewswire) - "The NDA is supported by positive results from a registrational clinical study led by Professor Shen Lin of Peking University Cancer Hospital and conducted across 34 clinical sites....Detailed results are planned for presentation at a leading international medical congress."

China filing • P1/2 data • Neuroendocrine Carcinoma

A Study of LBL-024 in Combination With Paclitaxel Bevacizumab for the Treatment of Platinum-resistant Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | N=110 ➔ 180

Enrollment change • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Nanjing Leads Biolabs…announced that its Phase II clinical study evaluating Opamtistomig (LBL-024)…in combination with bevacizumab for the treatment of first-line hepatocellular carcinoma (HCC) has successfully completed the safety run-in phase assessment following expert review and has advanced into the expansion phase (GlobeNewswire) - "Preliminary clinical data demonstrated that Opamtistomig in combination with bevacizumab has shown encouraging anti-tumor activity and a favorable safety profile in patients with HCC, supporting further clinical evaluation in the expansion phase....The encouraging clinical findings in HCC further strengthen the clinical validation of Opamtistomig’s differentiated mechanism and therapeutic potential."

Trial status • Hepatocellular Cancer

A Trial of LBL-024 Combined With Platinum-based Chemotherapy for the Treatment of Advanced EP-NEC (clinicaltrials.gov) - P3 | N=280 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P3 trial • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Leads Biolabs’ Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Completes Patient Enrollment in Phase II Study for Biliary Tract Cancer, Further Demonstrating Breakthrough Potential in Immune-Cold Tumors (The Manila Times) - "Detailed clinical data will be presented at the European Society for Medical Oncology (ESMO) Annual Meeting to be held in Madrid, Spain from October 23 to 27, 2026."

Enrollment status • P2 data • Biliary Tract Cancer

LBL-024: Regulatory submission in China for 3L+ extra-pulmonary neuroendocrine carcinoma in Q3 2026 (Leads Biolabs) - FY2025 Results

China filing • Neuroendocrine Carcinoma • Oncology

Nanjing Leads Biolabs…announced that its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), has received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate a pivotal Phase III clinical trial for the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) (PRNewswire) - "This randomized, double-blind, multicenter Phase III study is led by Professor Lin Shen of Peking University Cancer Hospital. The approval was based on the promising efficacy and favorable safety profile demonstrated by Opamtistomig in a successfully completed Phase Ib/II proof-of-concept study. Detailed results are planned to be presented at the 2026 ESMO Congress....Leads Biolabs plans to submit a Biologics License Application (BLA) in the third quarter of 2026 for Opamtistomig as a single agent for the treatment of advanced EP-NEC in the third-line or later setting. In parallel, Leads Biolabs is advancing multiple proof-of-concept studies and preparing to initiate at least two additional Phase III clinical trials for Opamtistomig, exploring its application across 13 solid tumor indications, including first-line NSCLC, first-line BTC, small cell lung cancer, and ovarian cancer..."

China filing • New P3 trial • P1/2 data • Biliary Tract Cancer • Lung Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer • Ovarian Cancer • Small Cell Lung Cancer

Nanjing Leads Biolabs…announced that the Center for Drug Evaluation (CDE) of the…NMPA has approved the investigational new drug (IND) application for an open-label, multicenter Phase Ib/II clinical trial of its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), in combination therapy for metastatic colorectal cancer (mCRC) (GlobeNewswire) - "The study is designed to evaluate the safety and efficacy of Opamtistomig combination regimens in patients with mCRC and to explore potential predictive biomarkers."

New P1/2 trial • Colorectal Cancer

Multiple Research Results Selected for Presentation at 2026 ESMO (HKEXnews) - "The Company is pleased to announce that six of its latest research results have been selected for presentation at the 2026 Annual Meeting of the European Society for Medical Oncology ('ESMO'). Among the selected six studies, two have been selected for highest level of oral presentation (Proffered Paper), four for poster presentations, covering extrapulmonary neuroendocrine carcinoma (EP-NEC), biliary tract cancer (BTC), and relapsed/refractory multiple myeloma (RRMM) and other therapeutic areas. In addition, the Company has been granted Late-Breaking Abstract ('LBA') eligibility and will submit the full LBA in September 2026."

Clinical data • Late-breaking abstract • Biliary Tract Cancer • Multiple Myeloma • Neuroendocrine Carcinoma

Nanjing Leads Biolabs has announced that its biologics license application for LBL-024, a PD-L1/4-1BB bispecific antibody branded as Opamtistomig, for monotherapy in advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) has been accepted into China’s priority review and approval procedure. (TipRanks) - "The application is supported by positive pivotal clinical data in patients whose disease progressed after at least two prior systemic therapies..."

China filing • Priority review • Gastrointestinal Neuroendocrine Carcinoma • Genitourinary Neuroendocrine Carcinoma • Gynecologic Neuroendocrine Carcinoma

WITHDRAWN: Survival outcomes and safety of opamtistomig (LBL-024), a novel PD-L1 and 4-1BB bispecific antibody, in combination with chemotherapy in treatment-naïve advanced extrapulmonary neuroendocrine carcinoma (EP-NEC): A phase Ib/II trial. (ASCO 2026) - P1/2 | "Clinical Trial Registration Number: NCT06157827 Abstract withdrawn."

Bispecific • Clinical • Combination therapy • Metastases • P1/2 data • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Nanjing Leads Biolabs…announced that the Phase II clinical study of its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), in combination with chemotherapy for the first-line treatment of non-small cell lung cancer (NSCLC), has been selected for an oral presentation at the 2026 World Conference on Lung Cancer (WCLC)… (PRNewswire) - "At WCLC 2026, the Company will present updated data demonstrating high response rates and continuously deepening tumor shrinkage of Opamtistomig in an expanded patient population, along with a safety profile consistent with previous findings. These results further validate the safety breakthrough enabled by conditional 4-1BB activation via the X-body platform and highlight Opamtistomig's differentiated clinical advantages in first-line NSCLC."

P2 data • Non Small Cell Lung Cancer