Suzhou, March 22, 2024 /PRNewswire/ -- Corning Jerry Biopharmaceuticals (stock code: 9966.HK) announced the results of a phase II clinical study (KN046-202) of PD-L1/CTLA-4 dual-antibody KN046 combined chemotherapy in first-line treatment of metastatic non-small cell lung cancer in CellCell Reports Medicine(IF:14.3) Full text published. Professor Zhang Li from Sun Yat-sen University Cancer Center is the corresponding author of this article, and Professor Zhao Yuanyuan is the first author.
Corresponding author: Professor Zhang Li
First author: Professor Zhao Yuanyuan
Article link: (24) 00116-2
Lung cancer is one of the most common malignant tumors in the world. It is the malignant tumor with the highest incidence rate and death rate in China. According to the latest report released by China's National Cancer Center in 2024, there were 1.06 million new cases of lung cancer and 733,300 deaths in China in 2022, far exceeding other tumor types. Non-small cell lung cancer (NSCLC) accounts for 80% to 90% of all lung cancers, and about 57% of patients have metastasized when diagnosed. Immune checkpoint inhibitors have made progress in the treatment of advanced non-small cell lung cancer in recent years, but the overall prognosis and long-term efficacy of patients still need to be improved urgently.
KN046-202 is a phase II, open, multicenter clinical study aimed at evaluating the efficacy, safety, and tolerability of KN046 combined with chemotherapy in first-line treatment of metastatic non-small cell lung cancer. Enrolled patients received KN046+ carboplatin+ pemetrexed (non-squamous NSCLC) /paclitaxel (squamous NSCLC) on day 1 of each cycle (3 weeks for 1 cycle). After 4 cycles, non-squamous NSCLC was maintained with KN046+ pemetrexed, and squamous NSCLC was maintained with KN046 monotherapy. The primary endpoints were confirmed objective response rate (ORR) and duration of remission (DoR), which were assessed by researchers according to RECIST 1.1.
A total of 87 patients were enrolled in the study, of which 51 were non-squamous NSCLC cohort and 36 were squamous NSCLC cohort. The median age was 61 years (32-76 years), of which 75.9% were men. As of March 15, 2022, the median follow-up period was 23.1 months.
Curative effect:The confirmed objective response rate (ORR) was 46.0% (95% CI: 35.2%-57.0%), and the median duration of remission (DoR) was 8.1 (95% CI: 4.14-13.90) months. The median progression-free survival (PFS) was 5.8 (95% CI: 5.26-7.10) months, the median overall survival (OS) was 26.6 (95% CI: 16.92-NR) months, and the 12-month OS rate was 74.2% (95% CI: 63.46%-82.18%). In the non-squamous NSCLC cohort, the confirmed ORR was 43.1%, the median dOR was 9.7 months, the median PFS was 5.8 months, and the median survival was 27.2 months; in the squamous NSCLC cohort, the confirmed ORR was 50.0%, the median dOR was 7.3 months, the median PFS was 5.7 months, and the median survival was 26.6 months.
safety:All 87 patients were included in the safety analysis. The most common drug-related adverse events (TRAEs) were anemia (87.4%), loss of appetite (72.4%), and decreased neutrophil count (70.1%). The number of cases of immune-related adverse events (iRAE), grade 3 and above, and severe iRAE was 50 (57.5%), 11 (12.6%), and 9 (10.3%), respectively. The most common irAEs are pruritus (28.7%), elevated aspartate aminotransferase (24.1%), and rash (21.8%).
The results showed that the first-line treatment of metastatic non-small cell lung cancer with KN046 combined with platinum-containing dual-drug chemotherapy was impressive and well tolerated. The study is expected to provide promising treatment options for this patient group.
regardingKN046
KN046 is a PD-L1/CTLA-4 bispecific antibody developed by Corning Jerry and has independent intellectual property rights. The innovative design of KN046 includes the fusion of CTLA-4 and PD-L1 single-domain antibodies with different mechanisms; it can target tumor microenvironments with high PD-L1 expression and remove Treg cells that inhibit tumor immunity.
KN046 has conducted nearly 20 clinical trials at various stages in Australia, the United States and China, covering more than 10 types of tumors, including non-small cell lung cancer, pancreatic cancer, thymus cancer, liver cancer, esophageal squamous cell carcinoma, and tri-yin breast cancer. The test results showed that patients had the advantage of survival benefits. Based on clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter phase II clinical trials in the US, and granted KN046 an orphan drug qualification for the treatment of thymic epithelial tumors in September 2020. Currently, many registered clinical trials of KN046 are ongoing. Among them, the mid-term analysis of the phase III clinical study of KN046 combined with chemotherapy on the first-line treatment of non-small cell lung cancer successfully reached the pre-set PFS endpoint.
About Corning Jerry
Corning Jerry is an innovative biopharmaceutical company dedicated to the discovery, development, production and commercialization of world-class anti-tumor drugs to provide patients with innovative biologic therapies. On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange (stock code: 9966.HK).
Corning Jerry has created a biomacromolecular drug development and production technology platform with independent intellectual property rights, such as protein/antibody engineering, antibody screening, and multi-module/multifunctional antibody modification. A product pipeline with significant differentiation advantages and strong international competitiveness has been created, covering innovative anti-tumor drugs such as single-domain antibody/monoclonal antibodies, multi-functional antibodies and antibody conjugates: 1 product, KN035 (the world's first subcutaneous PD- (L) 1 inhibitor, Envolimab injection, product name: Enweida) was approved for marketing in China in 2021, making it a widely accessible drug for cancer patients; 3 products are in late clinical development; HER2 double antibody KN026 was recognized as a breakthrough therapy by China's NMPA. In addition, the company has a rich early development pipeline, and 2 new drug molecules have already entered the clinical research stage.
“Kangda patients, Regis family”. Corning Jerry has always focused on unmet clinical needs and continues to develop safe, affordable, and globally competitive anti-tumor drugs to benefit patients.