The FDA has cleared the investigational new drug application for CHM 2101, a novel CDH17-targeted CAR T-cell therapy, for the treatment of patients with gastrointestinal cancers.
First-line treatment with the PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine led to a statistically significant improvement in overall survival vs placebo plus oxaliplatin and capecitabine in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, meeting the primary end point of the phase 3 AK104-302 trial.