The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had entered a Phase I/II clinical study in Australia for the treatment of solid tumors.
It is projected that after EGFR TKI treatment, a significant percentage of primary non-small cell lung cancer (NSCLC) and advanced EGFR mutated tumors will express HER3, which is a member of the receptor tyrosine kinase EGFR family. Although no HER3-targeted product is currently available globally, Daiichi Sankyo’s ADC, patritumab deruxtecan, was involved in a USD 22 billion deal with Merck, Sharp & Dohme (MSD; NYSE: MRK). Patritumab deruxtecan received breakthrough therapy designation (BTD) in the US in December 2021 and demonstrated promising results in the pivotal Phase II HERTHENA-Lung01 study for non-small cell lung cancer with EGFR mutations, achieving an objective response rate (ORR) of 29.8% and a median duration of remission of 6.4 months.
In a separate development, Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has recently initiated a Phase III trial in China for another ADC targeting EGFR and HER3 in recurrent or metastatic esophageal squamous cell carcinoma. Last month, Bristol-Myers Squibb (BMS; NYSE: BMY) entered into an USD 8.4 billion agreement with Biokin for the joint development and commercialization of this drug in the United States. – Flcube.com
