Leads Biolabs' Cancer Drug LBL-024 Shows Promising Phase II Results at 2024 ASCO Meeting

The annual meeting of the American Society of Clinical Oncology (ASCO) began on May 31, 2024, in Nanjing, China, bringing together cutting-edge cancer research from across the globe. This year, over 7,000 abstracts were submitted, and after thorough review by the Scientific Program Committee and ASCO Leadership, LBL-024, a bispecific antibody developed by Leads Biolabs, was chosen for an oral presentation. Today, Dr. Panpan Zhang unveiled the promising clinical data on LBL-024 during the Clinical Science Symposium focused on novel antibody-based approaches in gastrointestinal cancers.

LBL-024 is being evaluated in a phase I/II first-in-human, open-label, multicenter study. The research aims to assess the safety and efficacy of LBL-024 as a monotherapy for patients with advanced malignant tumors, including neuroendocrine carcinoma (EP-NEC). The results of this study indicated that LBL-024 has a favorable safety profile and notable antitumor effects, particularly in patients with extrapulmonary neuroendocrine carcinomas who have not responded to at least one line of chemotherapy.

Extrapulmonary neuroendocrine carcinoma (EP-NEC) is a rare and aggressive cancer that primarily affects the stomach, intestines, and pancreas. Unfortunately, most patients are diagnosed at a late stage, when the cancer has metastasized, leading to a grim prognosis. Currently, there are no approved treatments available for this fatal malignancy, and options for those who have progressed beyond first-line platinum-based chemotherapy are limited. This highlights the urgent need for new therapeutic strategies.

The oral presentation revealed that LBL-024 monotherapy exhibited a good safety profile, with mild liver toxicity observed in advanced solid tumors. Most adverse events (AEs) were mild (grade 1-2), and no unexpected AEs were reported. At a dose of 15 mg/kg, the objective response rate (ORR) was 37.5%, and the disease control rate (DCR) was 50.0% in second-line EP-NEC patients. Significant antitumor activity was observed over a wide therapeutic dose range (0.8-15 mg/kg). The median follow-up was 8.5 months, and the median duration of response (DoR) was 5.3 months. The median overall survival (mOS) was not reached, with six-month overall survival rates of 61.7% for the overall group, 72.7% for second-line patients, and 52.0% for those in the third line or beyond. Notably, a 54.5% ORR was seen in patients with PD-L1 negative expression (CPS<1), suggesting that LBL-024 can be effective regardless of PD-L1 expression in tumor tissue.

The promising efficacy data support further development of LBL-024 in EP-NEC patients. A single-arm pivotal study for LBL-024 monotherapy in EP-NEC was approved on April 30, 2024, aiming to expedite the approval process for LBL-024. Currently, there are no 4-1BB-targeting drugs available globally. LBL-024, with its First-in-Class potential, is expected to become the first approved standard treatment for EP-NEC following progression on second-line therapy, offering a new treatment option and hope for patients with advanced EP-NEC.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, highlighted that ASCO's selection criteria are stringent, and only the most impactful studies make it to oral presentations. He emphasized the innovative and efficient development strategy employed for LBL-024, which demonstrated strong safety and efficacy signals in patients with advanced malignant tumors.

Dr. Xiaoqiang Kang, Founder, Chairman, and CEO of Leads Biolabs, reiterated the company's commitment to innovative solutions, including developing new targets, drug molecule design, and clinical strategies. This approach ensures their products stand out from competitors and bring better therapeutic benefits. Leads Biolabs plans to continue focusing on unmet medical needs, pursuing innovation, and bringing clinically valuable drugs to patients swiftly.

LBL-024 is a bispecific antibody targeting PD-L1 and 4-1BB, designed to block the immunosuppressive pathway of tumor cells and stimulate T cells for a robust immune response. Leads Biolabs, established in Nanjing, is dedicated to developing novel antibody drugs for oncology and other major diseases. Their R&D pipeline includes over twenty novel therapies, aiming to address unmet patient needs globally.