Dalantercept: Interim Phase II data

Interim data from 20 evaluable patients with metastatic RCC in the first part of a 2-part, U.S. Phase II trial showed that subcutaneous 0.6, 0.9 or 1.2 mg/kg dalantercept given once every 3 weeks plus twice-daily 5 mg oral Inlyta axitinib led to an ORR of 25% plus 10 cases of stable disease. The combination was well tolerated with diarrhea, fatigue, anemia, arthralgia, creatinine increases, constipation, nausea, dysphonia, headache and muscle spasms reported as common treatment-related adverse events. The first part of the trial enrolled patients who progressed following <=3 prior therapies, including >=1 VEGF receptor tyrosine kinase inhibitor (TKI). Data will be presented at the American Society of Clinical Oncology meeting in Chicago.

In late May or early June, Acceleron plans to start the double-blind, placebo-controlled part 2 of the trial, which will compare the recommended Phase II dose of 1.2 mg/kg dalantercept plus Inlyta vs. Inlyta alone in patients who progressed following treatment with 1 VEGF receptor TKI. Dalantercept is also in Phase II testing for endometrial cancer, squamous cell carcinoma of the head and neck (SCCHN) and ovarian cancer. This quarter, Acceleron plans to start a Phase Ib trial of dalantercept plus sorafenib to treat hepatocellular carcinoma (HCC). ...