Gastric Cancer: New Clinical Study of Antibody with Chemotherapy

A HOLD FreeRelease | eTurboNews | eTN
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Written by Linda Hohnholz

Alphamab Oncology and CSPC Pharmaceutical Group Co., Ltd. jointly announced that the IND application for the pivotal clinical trial (KN026-CSP-001) of the anti-HER2 bispecific antibody KN026 combined with chemotherapy was approved by the Center for Drug Evaluation (CDE) of NMPA.

KN026-CSP-001 is a randomized, multi-center, phase II/III clinical study to evaluate the efficacy and safety of KN026 combined with chemotherapy in patients with HER2-positive gastric cancer (including gastroesophageal junction cancer) who have failed first-line treatment, with Professor Jianming Xu from the Chinese People’s Liberation Army General Hospital as principal investigator.

GC/GEJ is one of the common malignant tumors and there are more than 1 million new cases each year in the world. The incidence of gastric cancer is high in China, with about 410,000 new cases and 294,000 deaths each year, accounting for more than 40% of both new and death cases of GC/GEJ worldwide. Gastric cancer in China is characterized by low diagnosis rate of early gastric cancer, high proportion of metastatic stage (>80%) and low 5-year survival rate (about 35.1%), which seriously threatens the life and health of people. HER2 is overexpressed in many tumors, including about 15-20% in gastric cancer. HER2 overexpression is related to tumor aggressiveness and poor prognosis. With the development of targeted therapies, HER2-positive advanced gastric cancer patients have achieved better efficacy compared to traditional chemotherapy when treated with a combination of targeted drugs. However, for patients with HER2-positive gastric cancer who have progressed or recurred after first-line treatment, there is no effective drug approved in China, and there is a huge unmet clinical need.

KN026 is a HER2 bispecific antibody developed by Alphamab Oncology. Data from the Phase II clinical study of KN026, published at ASCO in 2021, demonstrated favorable safety and promising efficacy in Chinese HER2 overexpressing GC/GEJ patients, pretreated either with or without anti HER2 treatments. In patients with high expression, the ORR was 55.6% and the DCR was 72.2%, and the 9-month PFS rate was 60.4%. Among patients receiving prior-HER2 treatment, the ORR was 44.4%, and the DCR was 66.7%. The approval of the clinical trial application is a touchstone for the cooperation between Alphamab Oncology and CSPC to accelerate the clinical development and commercialization of KN026 in mainland China. We hope to see more positive data from the study, and bring hope to patients with advanced gastric cancer who are in urgent need of new treatment options.

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Avatar of Linda Hohnholz

Linda Hohnholz

Editor in chief for eTurboNews based in the eTN HQ.

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