Daiichi Sankyo has initiated the Phase II DESTINY-Gastric01 clinical trial of its investigational antibody drug conjugate (ADC) DS-8201 in patients with advanced gastric or gastroesophageal junction adenocarcinoma.

DS-8201 is described as smart chemotherapy with a humanised HER2 antibody connected to a new topoisomerase I inhibitor (DXd) payload by a tetrapeptide-based linker for delivering chemotherapy inside cancer cells and minimising systemic exposure.

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The trial has started patient recruitment in Japan and South Korea to evaluate the safety and efficacy of DS-8201 for HER2-expressing cancer that is resistant or refractory to trastuzumab.

Approximately 180 patients who experienced disease progression even after two prior regimens of fluoropyrimidine agent, platinum agent and trastuzumab will be included in the trial.

“This will allow us to evaluate whether the smart delivery of chemotherapy with DS-8201 may be a potential new treatment option to address the high unmet medical need of gastric cancer.”

Daiichi Sankyo Research and Development division Oncology Function head Koichi Akahane said: “Japan and South Korea have some of the highest rates of gastric cancer worldwide and there have been limited advances in targeted treatments over the past decade.

“The initiation of this pivotal study will allow us to evaluate whether the smart delivery of chemotherapy with DS-8201 may be a potential new treatment option to help address the high unmet medical need of gastric cancer.”

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The primary objective of the open-label trial is objective response rate, while the secondary endpoints include pharmacokinetics, safety, progression-free survival, duration of response, overall survival, disease control rate and time to treatment failure.

Two non-randomised exploratory cohorts will also be included in the trial to assess the safety and efficacy of the investigational agent in a total of 40 patients who have not previously undergone treatment with a HER2-targeting therapy.