Daiichi Sankyo initiates phase III trial of ifinatamab deruxtecan (I-DXd) in China for advanced esophageal cancer
On September 26, Daiichi Sankyo announced that the first patient has been successfully dosed in China in the Phase III study (IDeate-Esophageal01) evaluating ifinatamab deruxtecan (a B7-H3-directed ADC) as a second-line treatment for advanced/metastatic esophageal squamous cell carcinoma.
Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part Phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with ES-SCLC previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible to participate.
The primary endpoint is ORR as assessed by BICR per RECIST v1.1. Secondary endpoints included DOR, PFS, DCR, TTR, OS, pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis. IDeate-Lung01 plans to enroll approximately 510 subjects across North America, Europe, and Asia.
Daiichi Sankyo has entered into a collaboration with Merck for the global co-development and co-commercialization of ifinatamab deruxtecan, excluding Japan.
In addition to esophageal squamous cell carcinoma, ifinatamab deruxtecan is being evaluated in two additional Phase III studies in China, targeting small cell lung cancer and castration-resistant prostate cancer, respectively. On September 25, the drug's application for the treatment of adult patients with extensive-stage small cell lung cancer was included in the Breakthrough Therapy Designation public list by China's Center for Drug Evaluation (CDE).