Leads Biolabs Unveils Promising LBL-024 Results at 2025 ASCO Meeting

Introduction

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Nanjing Leads Biolabs Co., Ltd. unveiled groundbreaking clinical results for LBL-024, a novel bispecific antibody targeting PD-L1 and 4-1BB. This study focuses on treatment-naive patients suffering from advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). The research, part of a multicenter phase Ib/II clinical trial, highlights the potential of LBL-024 when used in combination with chemotherapy agents such as etoposide and platinum-based drugs.

Key Highlights from the Study

The clinical trial results presented at ASCO are a significant advancement in the treatment of EP-NEC, particularly because there are limited available therapies for this aggressive cancer type.

Efficacy Data

In a cohort of 52 patients, the overall response rate (ORR) stood at a striking 75.0%, with the disease control rate (DCR) reported at 92.3%. When focusing on the 15 mg/kg dosage, the study revealed that the ORR surged to 83.3%, with an encouraging 100% DCR. Notably, over half (57.7%) of the subjects demonstrated more than a 50% reduction in tumor size during the trial.

With a median follow-up period extending to 8.2 months as of April 15, 2025, the long-term efficacy indicators, including progression-free survival (PFS), suggest a favorable outcome across various dosage groups, despite the data still being categorized as immature.

Safety Profile

The findings also revealed a healthy safety profile for LBL-024. Throughout the phase Ib trial stage, researchers reported no dose-limiting toxicities (DLTs). Adverse events, primarily linked to chemotherapy, were classified as manageable Grade 1–2 reactions, indicating a strong therapeutic window. Importantly, there were no unexpected safety signals that emerged from this innovative treatment approach.

Expert Commentary

Dr. Charles Cai, the Chief Medical Officer of Leads Biolabs, expressed enthusiasm over the trial results. He highlighted LBL-024's potential to advance into pivotal phase III trials, reinforcing its role as a frontrunner in first-line treatment protocols for EP-NEC. He added that the drug's regulatory approval to initiate a single-arm pivotal trial in China marks a significant milestone for targeted cancer therapies worldwide.

Dr. Xiaoqiang Kang, the company’s Founder and Chairman, remarked on the continuous recognition of LBL-024 in significant conferences, attributing its success to an innovative research and development strategy focused on addressing pressing clinical needs and driving impactful therapies.

About LBL-024

LBL-024 is positioned to be the first-in-class bispecific antibody to treat advanced EP-NEC. Its dual-action mechanism targets both PD-L1, which suppresses immune responses, and the 4-1BB receptor, essential for T-cell activation. Developed via the proprietary X-Body™ platform, LBL-024 aims to improve patient outcomes significantly.

The treatment has already garnered key regulatory designations, namely Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) in China and Orphan Drug Designation by the FDA in the U.S.

The clinical evidence supporting LBL-024 extends beyond EP-NEC, showcasing promise in various other malignancies including small cell lung cancer and ovarian cancer, with the potential for broader indications in the future.

Conclusion

Leads Biolabs' presentation at the 2025 ASCO meeting marks a significant milestone in the ongoing quest to find effective treatments for difficult-to-treat cancers such as EP-NEC. The results underscore the hope that innovative therapies like LBL-024 could soon play a pivotal role in transforming cancer care and improving outcomes for patients globally.