Monitors call early stop to Imbruvica CLL trial
A Phase-III trial of Janssen and Pharmacyclics' Imbruvica (ibrutinib) testing an expanded use for the drug, in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), was stopped early on the recommendation of an Independent Data Monitoring Committee (IDMC). Monitors said the drug had already met its primary endpoint and a key secondary one: statistically significant improvement in progression free survival (PFS) and overall survival (OS).
Janssen and Pharmcyclics—who signed a collaborative agreement in December 2011 to co-develop and market the drug—said data from the trial will be presented at an upcoming oncology conference. Pharmacyclics has informed FDA of this data; Janssen has informed the European Medicines Agency (EMA).
Imbruvica was approved in November for treating mantle cell lymphoma (MCL), after receiving priority review in July of last year. Analysts have said the drug could reach billions in annual sales, owing to its oral formulation and potential to be used without chemo, traits that have drawn comparisons to Novartis's blockbuster leukemia pill Gleevec.