On November 6, at the 5th China International Import Expo (hereinafter referred to as "CIIE"), LBP and AstraZeneca joined hands with many partners in the precision diagnosis ecosystem to establish the MET HER2 Tumor Precision Diagnosis Alliance. The alliance aims to make full use of the diagnostic and pharmaceutical advantages, promote technology exchange, resource sharing and win-win cooperation among partners, actively promote the exploration of innovative diagnostic solutions for relevant patients based on the clinical needs and innovative technologies, and support the realization of the strategic goal of Healthy China 2030 Initiative.
Drug innovation drives diagnostic development and promotes a new era of MET HER2 precision therapy
MET gene amplification is one of the mechanisms of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) resistance. For incipient patients, the incidence of MET gene amplification is 4%, while for NSCLC patients with acquired first- and second-generation EGFR-TKI resistance, the incidence of MET gene amplification is 4% to 20%. MET gene amplification is the most common mechanism of acquired resistance in NSCLC patients receiving first-line third-generation EGFR-TKI osimertinib (incidence of 15%) with progression or interruption. AURA3 study showed that MET gene amplification has a higher incidence in NSCLC patients receiving second-line osimertinib treatment, up to 19%. In addition, SAVANNAH study showed that of the approximately 460 patients who progressed after treatment with osimertinib, IHC50+ and/or FISH5+ patients accounted for up to 62% and IHC90+ and/or FISH10+ patients also accounted for 34%; furthermore, the study suggested that NSCLC patients who were IHC90+ and/or FISH10+ would be more likely to benefit from savolitinib and osimertinib treatment than other patients.
HER2 is a receptor protein that enables rapid growth of cancer cells. During breast cancer diagnosis and treatment, the patient's HER2 gene expression level is an important indicator for clinical treatment monitoring and prognosis. Scoring the expression level of HER2 receptor protein in breast cancer tissue samples can provide guidance for decision-making of HER2-targeted therapy. If a patient has high HER2 expression levels (IHC 3+ or IHC 2+/ISH +), the patient is confirmed to be HER2-positive and HER2-targeted therapy may be considered. However, approximately half of patients with metastatic breast cancer have low HER2 expression (IHC 1+ or 2+/ISH negative), a category previously classified as HER2 negative with no corresponding targeted therapy to help improve their outcomes. In August 2022, based on the breakthrough efficacy of DESTINY-Breast04, the U.S. Food and Drug Administration (FDA) approved the innovative ADC DS-8201 for the treatment of unresectable or metastatic HER2 low expression (IHC 1+ or IHC 2+/ISH -) adult breast cancer patients who have received at least one prior chemotherapy at the metastatic disease stage, or have relapsed during or within 6 months after completing adjuvant chemotherapy. This not only indicates the beginning of the era of precision treatment for "HER2 low expression" breast cancer, but also represents a disruptive change in clinical typing and treatment standards for HER2 breast cancer.
LBP has developed integrated solutions for morphological companion diagnostics
For joining the "MET HER2 Tumor Precision Diagnosis Alliance", He Xin, Director of LBP IHC Division, explained the LBP's thinking on the IHC CDx business:
The first is the innovation of the companion diagnostics market access mode. FDA always followed the principle of "one drug corresponding to one test" when approving companion diagnostic products in the past. However, in China, which has a large population base and different medical levels, there are more than 6,000 sets of IHC devices, including many domestic brands as well as mainstream international brands. This phenomenon makes the access of CDx single-technology platform far from meeting the diagnosis and treatment needs of cancer patients. LBP is exploring the mode innovation of dual-technology platform or even multi-technology platform.
The second is the innovation of products. For a long time, domestic IHC reagents adopt a supply mode of globalized raw materials, and the antibody R&D capability is weak, but the product requirements of CDx pose a great challenge to this mode. Because CDx products have a long R&D cycle and need to be companioned by drugs for a long time after approval for marketing, diagnostic enterprises must ensure a stable supply of products over a decades-long period, which emphasizes the originator raw material development capabilities of diagnostic enterprises on the one hand, and requires enterprises to have a closed-loop supply chain capability from reagents to devices on the other hand.
The last is the innovation of reading mode. Most of the IHC companion diagnostic radiographs need to be accurately quantified, which is a great challenge for the pathologists to read the radiographs. Digital and AI reading is expected to reduce the burden of pathologists and empower them, which is the future development direction of IHC companion diagnostics.
As a domestic listed company focusing on the field of pathological diagnosis, LBP has made technology reserve in the above three directions very early. Currently, LBP has more than 200 self-produced IHC clonal antibodies, more than 300 FISH independent probe synthesis technologies, and AI-assisted diagnostic products are also in the process of registration application for Class III certificates.
As early as 2013, LBP obtained the first Class III medical device registration certificate for HER2 kit (IHC method) in China, and now it further provides both IHC and FISH solutions for MET and HER2 targets. In the field of "morphological companion diagnostics", LBP is expected to provide overall solutions from testing reagents, supporting equipment and digital and AI reading based on its accumulation in IHC, FISH and AI.
By joining AstraZeneca's Alliance for Companion Diagnostics and Precision Testing, LBP will also take a more active role in collaborating with AstraZeneca, the companies in the Alliance and the users in the industry to help the standardization of the industry and make its due contribution to the precision diagnosis and treatment of tumors.
About AstraZeneca
AstraZeneca is a science-focused, global biopharmaceutical company that is committed to the R&D, production and marketing of prescription medicines with a focus on tumors, rare diseases and biopharmaceuticals including cardiovascular, renal and metabolic, respiratory and immune drugs. With global headquarters in Cambridge, UK, AstraZeneca operates in more than 100 countries and its innovative medicines benefit millions of patients worldwide.
Since its entry into China in 1993, AstraZeneca has focused on the most urgent treatment areas for Chinese patients, including tumors, cardiovascular, renal, metabolic, respiratory and digestive diseases, vaccine and antibody, autoimmunity, rare diseases, and has brought nearly 40 innovative drugs to China. With China headquarters in Shanghai, and regional headquarters in Beijing, Guangzhou, Hangzhou, Chengdu, Wuxi and Qingdao, the Company has established manufacturing bases and logistics centers in China to export pharmaceuticals to nearly 70 countries and regions around the world. Today, China has grown into AstraZeneca's second largest market in the world.
