- Daiichi Sankyo and Merck have initiated a phase 3 trial for ifinatamab deruxtecan (I-DXd) in patients with advanced esophageal squamous cell carcinoma (ESCC).
- The trial will evaluate the drug's efficacy and safety against the physician's choice of chemotherapy.
- Approximately 510 patients will be enrolled globally, as current treatments remain limited for progressed ESCC.
The IDeate-Esophageal01 trial marks an important step in addressing the unmet needs in the treatment of advanced or metastatic esophageal squamous cell carcinoma (ESCC). Daiichi Sankyo (TSE: 4568) and Merck (MRK, Financial) are collaborating on this global, multicenter phase 3 trial to evaluate the efficacy and safety of the investigational drug ifinatamab deruxtecan (I-DXd) compared to the investigator’s choice of chemotherapy. Currently, patients who have experienced disease progression following platinum-containing systemic therapy and an immune checkpoint inhibitor have limited treatment options.
Ifinatamab deruxtecan is a specifically engineered, B7-H3 directed antibody drug conjugate (ADC) that has shown promising results in early trials. The IDeate-Esophageal01 trial aims to enroll approximately 510 patients from Asia, Europe, and North America, and its primary endpoint is overall survival. Secondary endpoints include progression-free survival and objective response rate.
ESCC constitutes about 90% of esophageal cancer cases globally, with survival rates remaining low, especially in Eastern Asia. This trial seeks to innovate in the first-in-class therapeutic strategies and improve outcomes for patients with this challenging diagnosis. More information on the trial can be found on ClinicalTrials.gov.
Daiichi Sankyo and Merck’s joint efforts extend beyond ESCC, as ifinatamab deruxtecan is also being tested in various other solid tumors, including lung cancer, under their comprehensive global development program.