Daiichi Sankyo Company has dosed the first patient in a Phase ll trial evaluating the efficacy and safety of DS-8201 for the treatment of patients with unresectable and/or metastatic non-squamous HER2-overexpressing or HER2-mutated non-small cell lung cancer (NSCLC) that has progressed after one or more prior therapies.
The global, multicentre, open-label, two-cohort trial includes two cohorts, one and two.
The cohort one will enrol nearly 40 patients with HER2-overexpressing (defined as IHC 3+ or IHC 2+), unresectable and/or metastatic non-squamous NSCLC, while the cohort two will include about 40 patients with HER2-mutated, unresectable and/or metastatic non-squamous NSCLC.
The trial’s primary endpoint is to achieve an objective response rate.
Its key secondary endpoints are efficacy, safety, and pharmacokinetic endpoints. Exploratory efficacy endpoints of the trial include time to respond, in addition to biomarker endpoints for mechanisms of response and resistance.
Around 80 patients are scheduled to be enrolled in the trial at 20 sites in North America, Japan, and Europe.
Daiichi Sankyo Oncology Research and Development Global Team Leader DS-8201 vice-president Gilles Gallant said: “There is renewed interest in exploring alterations in the HER2 pathway as treatment targets for NSCLC and clinical research suggests a potential role for a HER2-targeting ADC agent.
“DS-8201 is specifically designed to target and deliver chemotherapy inside HER2-expressing cancer cells, and we are advancing it to Phase ll in non-small cell lung cancer as part of our broad programme in multiple types of HER2-expressing tumours.”
According to World Health Organization’s Cancer Fact Sheet 2017 and other research, lung cancer is estimated to be the most common cancer in the world and the major cause of cancer deaths.
They have also estimated that about 1.8 million new cases of lung cancer were reported globally in 2012 and nearly 1.69 million deaths occurred globally due to lung cancer in 2015.