The Chinese Society of Clinical Oncology (CSCO) Guidelines Conference was held on April 23-24, 2022, which attracted top experts from Chinese clinical oncology community and interpreted the updates of 2022 CSCO Diagnosis and Treatment Guidelines. Envafolimab was included for the first time into 3 CSCO guidelines, and received recommendation and attention by experts during the meeting.
Envafolimab, the world's first single-domain PD-L1 antibody formulated for subcutaneous injection co-developed by Alphamab Oncology (stock code: 9966.HK)，3DMed and Simcere, was approved for marketing since November 2021 and has been well acknowledged by the Chinese clinical oncology community and recommended by 3 updated CSCO 2022 guidelines, including:
1. CSCO Guidelines for Gastric Cancer 2022 Version (Class I recommendation, Level 2A evidence)
2. CSCO Guidelines for Colorectal Cancer 2022 Version (Class II recommendation, Level 2A evidence)
3. CSCO Guidelines for Clinical Application of Immune Checkpoint Inhibitors 2022 Version (Class I recommendation, Level 2A evidence)
CSCO experts from the GI Cancer Session commented: “Envafolimab is recommended for the treatment of dMMR/MSI-H metastatic advanced gastric cancer patients (regardless of HER2 status) who have not received prior PD-1/PD-L1 monoclonal antibody, Level 2A evidence, Class I recommendation. This update is based on the results of the multi-center, single-arm phase II study in China (KN035-CN-006), with an ORR of 44.4% and a 12-month OS rate of 83.3% in patients with advanced gastric cancer. On November 24, 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of MSI-H or dMMR advanced solid tumors.”
CSCO experts from the Immune Checkpoint Inhibitors Session commented: “One of the highlights of 2022 version of CSCO guideline for immune checkpoint inhibitors is adding a new section on MSI-H/dMMR. Envafolimab was recommended in the ≥2L treatment of advanced solid tumors such as MSI-H/dMMR colorectal cancer based on the data from a pivotal phase II clinical study(KN035-CN-006),Class I recommendation, Level 2A evidence."
Envafolimab is not only the world’s first subcutaneously administered PD-L1 antibody, but also the first immunotherapy drug with cross-tumor indication (MSI-H/dMMR) in China. Based on its unique design that allows rapid subcutaneous injection, it has advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not require an intravenous infusion which lowers medical costs. The nature of SC injection make it possible to be administered in community hospitals or even at home.
The CSCO Guidelines are recognized as the most authoritative clinical guidance and the gold standard in the clinical practice for Chinese oncology clinicians. Envafolimab has been well acknowledged by the Chinese oncology community and recommended by 3 updated CSCO 2022 guidelines. Under the guidance of CSCO guidelines, this innovative product is expected to better serve the clinical treatment of oncology in China and benefit more patients.
About Envafolimab（KN035）
Envafolimab is a single domain Fc fusion PD-L1 antibody independently invented by Alphamab Oncology，and co-developed with 3D (Beijing) Medicines since 2016. On March 30, 2020, Alphamab Oncology, 3DMed, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and 3DMed is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of products in mainland China.
Based on its unique design that allows rapid subcutaneous injection, it has advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not require an intravenous infusion which lowers medical costs. At present, Envafolimab is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of MSI-H or dMMR advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options.
About Alphamab Oncology
Alphamab Oncology is focusing on innovation, including discovery, development, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.
Alphamab has a fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Five products have advanced into phase I-III clinical trials in China, the United States, Japan and Australia and in November 2021, one of these products, the unique PD-L1 antibody for subcutaneous administration, Envafolimab, received marketing authorization from the Chinese National Medical Products Administration (NMPA) for the treatment of previously treated MSI-H/dMMR advanced solid tumors.
The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA’s cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.
Alphamab Oncology Forward-Looking Statements
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