Henlius Small-Cell Lung Cancer Clinical Trial Meets Primary Endpoint
By Rachel Ernst |
In a Phase 3 small-cell lung cancer clinical trial in China, Shanghai Henliu Biotech, Inc. announced that the study met its primary endpoint. The study, assessing the use of first-line PD-1 inhibitor serplulimab plus chemotherapy in small-cell lung cancer (SCLC), indicated the combination improved the overall survival of participants. The successful results mean the study’s primary endpoint has been met.
The small-cell lung cancer clinical trial announcement came from a press release from Henlius earlier this month. Currently, an approved PD-1 inhibitor to treat extensive-stage SCLC does not exist. With efficacy and safety standards met, the treatment combination is on its way to approval.
The study’s principal investigator, Professor Ying Cheng, serves as the Director of Jilin Department of Medica Oncology Cancer Center, Jilin Province Lung Cancer Diagnosis and Treatment Center, and Jilin Cancer Hospital Malignant Tumor Clinical Research Integrated Diagnosis and Treatment Center.
In the biotech company’s press release, Cheng said: “This study is the first and largest ES-SCLC international multi-center clinical study led by Chinese researchers for anti-PD-1 mAb. The favorable clinical results show China’s ability to innovate with a high clinical trial level. We are looking forward to serplulimab launching as soon as possible, which brings a drug with Chinese independent intellectual property to patients with small cell lung cancer all over the world.”
About The Small-Cell Lung Cancer Clinical Trial
The main point of the study explored the safety and efficacy of serplulimab in combination with chemotherapy. Patients who received chemotherapy either received carboplatin or etoposide. About 567 patients with untreated extensive-stage small-cell lung cancer participated in the double-blind study.
Participants were required to have adequate major organ function for eligibility. The study subjects received the serplulimab via injection. The small-cell lung cancer clinical trial took place in Shanghai, China in collaboration with Henlius Biotech.
Current clinical studies involving serplulimab investigate its potential success in treating other cancers. Serplulimab may serve as a possible treatment option for gastric, colorectal, cervical, liver, and squamous cell cancers.
How Does Serplulimab Work?
SCLC is an aggressive type of lung cancer. The type of cancer cells in SCLC patients easily metastasis, leading to a poorer prognosis. The standard treatment options are chemotherapy or chemotherapy combined with other PD-L1 inhibitors. Even after chemotherapy, the average 5-year survival rate is less than 5%.
Serpluliumab may bring a new option for anti-PD-1 treatment. The monoclonal antibody works with the immune system to destroy tumor cells. Once administered, serpluliumab targets and binds to a protein found in immune cells, called PD-1. Once inhibited to PD-1, the antibody signals an immune response via cancer-cell fighting T-cells.
The President of Henlius, Jason Zhu, said in the press release, “Serplulimab is an innovative mAb independently developed by Henlius, and the company has carried out a comprehensive first-line treatment layout for lung cancer. Based on a large number of unmet clinical needs, the company has invested in SCLC. The excellent results of this Phase 3 study are expected to contribute to serplulimab in becoming the first anti-PD-1 mAb for the first-line treatment of SCLC, which will significantly improve the overall prognosis. Henlius focuses on high-incidence cancers both globally and in China. In the future, we will proactively promote the combination immunotherapy of serplulimab and international clinical research, benefiting more patients around the world.”