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ARTICLE | Clinical News

Merck reports Phase Ia data for DNA-PK inhibitor M3814 in solid tumors

June 15, 2017 5:09 PM UTC

Merck KGaA (Xetra:MRK) reported data from 7 evaluable patients with advanced solid tumors or metastases including lymphoma localized in the head and neck region or thorax in the Phase Ia portion of a Phase Ia/Ib trial showing that once-daily 100 mg oral M314 (MSC 2490484A) plus palliative radiotherapy led to local tumor control at >300 days in 2 patients. There was 1 dose-limiting toxicity (DLT) of grade 3 mucositis lasting >7 days reported. The most frequent adverse events reported were fatigue, constipation, reduced appetite, dry mouth, dysphagia, headache, oral pain, radiation skin injury and mucositis. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

The Phase Ib portion of the open-label, U.S. and German trial will enroll patients with squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC). The trial's primary endpoint is evaluating DLTs and safety. Secondary endpoints include best overall response rate (ORR), tumor size, progression-free survival (PFS), overall survival (OS) and pharmacokinetics...