Daiichi Sankyo Company has signed a clinical trial collaboration agreement with a Merck subsidiary to conduct a Phase lb trial to investigate DS-8201 in combination with Keytruda (pembrolizumab) in HER2 expressing advanced/metastatic breast and HER2 expressing or HER2 mutant non-small cell lung cancers (NSCLC).
The two-part, multicentre, open-label trial intends to identify the safety, tolerability, efficacy and dose of DS-8201 and Keytruda among the enrolled patients.
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It plans to distribute the patients into four cohorts, one of which will include patients with HER2 positive advanced breast cancer who have been previously treated with ado-trastuzumab emtansine (T-DM1) (cohort 1).
The remaining cohorts will enrol patients with HER2 low-expressing advanced breast cancer who have received available standard of care, patients with HER2 expressing advanced NSCLC who have not received prior treatment with anti-PD-1 or anti-PD-L1 agents, and patients with HER2 mutant advanced NSCLC who have not received prior treatment with anti-PD-1 or anti-PD-L1 agents.
The trial’s primary objectives are maximum-tolerated dose/recommended expansion dose and overall response rate.
Its secondary objectives comprise duration of response, disease control rate, progression-free survival, overall survival, time to response, and safety.
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By GlobalDataThe trial is set to enrol around 125 patients across the US and Europe.
Daiichi Sankyo Oncology Research and Development Antibody Drug Conjugate Task Force head and vice-president Tom Held said: “Strategic collaborations like this support our goal to pursue, investigate and maximise the application of DS-8201 in combination with other compounds that target different pathways to address unmet needs of patients with cancer.”
DS-8201 is an investigational solution designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to chemotherapy compared to the common delivery of chemotherapy.
