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.
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.
The 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.