Updated Data Show Promising Results for Opamtistomig in NSCLC Treatment

NANJING, China, Sept. 14, 2026 /CourierPR/ -- Nanjing Leads Biolabs Co., Ltd. announced that updated Phase II data for opamtistomig (LBL-024), its proprietary PD-L1/4-1BB bispecific antibody, in combination with chemotherapy for first-line non-small cell lung cancer (NSCLC) treatment, were presented at the 2026 World Conference on Lung Cancer (WCLC). The data demonstrated robust and durable antitumor activity across both squamous and non-squamous NSCLC, highlighting the potential of opamtistomig’s dual-target mechanism to broaden the clinical benefit of immunotherapy in first-line NSCLC.

The study involved 63 treatment-naïve patients, including 31 non-squamous and 32 squamous NSCLC patients. More than 90% of the patients had stage IV disease, with many presenting multiple metastases, including brain and liver metastases. Only 35.5% of non-squamous and 43.8% of squamous patients had PD-L1 TPS ≥1%, significantly lower than the general NSCLC population. Median follow-up was 7.1 months. Among 62 efficacy-evaluable patients, the overall response rate (ORR) was 71.0%, the disease control rate (DCR) was 95.2%, and the 6-month progression-free survival (PFS) rate was 70.6%.

In squamous NSCLC, the ORR was 87.1%, the DCR was 96.8%, and the 6-month PFS rate was 86.7%. The study observed comparable benefit regardless of PD-L1 expression, with ORRs of 84.6% in PD-L1-positive and 88.2% in PD-L1-negative patients, and 6-month PFS rates of 84.6% and 87.4%, respectively. In non-squamous NSCLC, among PD-L1-positive patients, the ORR was 81.8%, the DCR was 100.0%, and the 6-month PFS rate was 90.0%. Notably, substantial responses were also observed in patients with low PD-L1 expression (TPS 1%, 49%).

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, commented, "The updated WCLC data are highly encouraging. With longer follow-up, tumor shrinkage continued to deepen, and ORR continued to increase, providing further evidence of the durability of opamtistomig’s antitumor activity. Particularly noteworthy is the consistent efficacy observed regardless of PD-L1 expression in squamous NSCLC, together with deep and durable responses in PD-L1-positive non-squamous NSCLC, including patients with low PD-L1 expression."

Despite more than 90% of patients having stage IV disease and many presenting with difficult-to-treat metastatic disease, opamtistomig plus chemotherapy continued to demonstrate encouraging efficacy and PFS outcomes. These findings further support its potential clinical value in first-line NSCLC. The company is advancing Phase III development and looks forward to bringing this next-generation immunotherapy to more patients.

Opamtistomig (LBL-024) is a PD-L1/4-1BB bispecific antibody designed to simultaneously block PD-1/PD-L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It is currently being evaluated in 14 solid tumor indications, with clinical evidence emerging across seven tumor types, including NSCLC, esophageal squamous cell carcinoma (ESCC), extrapulmonary neuroendocrine carcinoma (EP-NEC), biliary tract cancer (BTC), and platinum-resistant ovarian cancer. Approximately 800 patients with solid tumors have been treated to date, with a favorable overall safety profile.

Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally. The company's pipeline includes 15 innovative drug candidates, including five clinical-stage drug candidates and one registration-stage asset.