Daiichi Sankyo and MSD have announced the first subject dosing in the Phase III Ideate-Esophageal01 trial, assessing the safety and efficacy of ifinatamab deruxtecan (I-DXd) in individuals with unresectable advanced or metastatic oesophageal squamous cell carcinoma (SCC).
The trial compares the therapy to the investigator’s choice of chemotherapy in patients with disease progression after platinum-containing systemic therapy and an immune checkpoint inhibitor treatment.
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This global trial was commenced based on outcomes from the earlier IDeate-PanTumor01 Phase I/II trial.
The open-label, multi-centre, randomised IDeate-Esophageal01 study compares I-DXd (12mg/kg) to the physician’s choice of chemotherapy (docetaxel, paclitaxel, or irinotecan hydrochloride).
Overall survival is the trial’s primary endpoint, with secondary endpoints including safety assessments, progression-free survival and objective response rate, measured using a blinded independent central review.
Approximately 510 subjects across Europe, North America, and Asia will be enrolled in the trial.
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By GlobalDataDaiichi Sankyo oncology development head Mark Rutstein said: “Patients with metastatic oesophageal SCC continue to experience poor outcomes despite currently available treatments.
“The encouraging clinical activity seen in our early-phase signal finding trial supports further evaluation of I-DXd as a potential treatment strategy for these patients.”
I-DXd, the B7 homolog 3 (B7-H3) directed DXd antibody drug conjugate (ADC), is designed using Daiichi Sankyo’s DXd ADC Technology.
It has received orphan drug designation in the European Union (EU), Taiwan, the US, and Japan for small cell lung cancer (SCLC).
In October 2023, Daiichi Sankyo and MSD signed a worldwide partnership to co-develop and commercialise several therapies, including I-DXd, for which Daiichi Sankyo will manage the manufacturing and supply.
The collaboration was expanded last August to include gocatamig (MK6070/DS3280), with MSD overseeing its supply and manufacture.
In September 2024, the companies reported that the Phase III HERTHENA-Lung02 trial of patritumab deruxtecan met its primary endpoint of progression-free survival in patients with EGFR-mutated non-small cell lung cancer (NSCLC).
