Imbruvica combo meets Phase III endpoint

Pharmacyclics Inc. (NASDAQ:PCYC) said Imbruvica ibrutinib plus bendamustine and rituximab met the primary endpoint of improving progression-free survival (PFS) vs. placebo in the Phase III HELIOS trial to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The company said an Independent Data Monitoring Committee recommended unblinding the data after an interim analysis. HELIOS enrolled 578 CLL or SLL patients who had received at least one line of prior systemic therapy. The company said safety data were consistent with previous studies, but did not provide details. ...