MONDAY, JUNE 25, 2018

Janssen ends cancer treatment study early after positive results

Janssen Research & Development LLC, part of the Janssen Pharmaceutical Companies, announced the early stopping on Tuesday of a Phase III study of ibrutinib in the treatment of certain cancers on a planned interim analysis.

An independent data monitoring company concluded the study showed a significant difference in progression-free survival of chronic lymphocytic leukemia and small lymphocytic lymphoma patients as compared to the control. The international, randomized open-label Phase III clinical study tested ibrutinib, also known as IMBRUVICA, in 391 patients with relapsed or refractory CLL/SLL with measurable nodal disease who were ineligible for treatment with purine analog-based therapy and received at least one prior therapy.

The primary endpoint of the study was PFS with overall survival as a key secondary endpoint.

The IDMC observed statistically significant differences in PFS and OS and agreed the results suggest evidence of clinical benefit and a tolerable safety profile when compared to intravenous doses of ofatumumab.

"We're delighted with this outcome, and look forward to sharing these results with the scientific community and Health Authorities," Peter Lebowitz, the oncology therapeutic area head for Janssen Research & Development, said. "This Phase III randomized study provides a useful head-to-head comparison of single agent ibrutinib versus ofatumumab, and builds upon the early evidence of clinical benefit observed in the ibrutinib Phase II program."

CLL is a slow-growing cancer of the white blood cells and is the most common adult leukemia. SLL is a slow-growing lymphoma in which too many immature white blood cells cause lymph nodes to become bigger than normal.

Ibrutinib was approved in November in the U.S. as a single agent for the treatment of patients with mantle cell lymphoma who received at least one prior therapy.