Janssen and Pharmacyclics’ Imbruvica meets key endpoints early in Phase III leukemia trial

USA-based Pharmacyclics (Nasdaq: PCYC) and co-developer Janssen Biotech have announced that an Independent Data Monitoring Committee unanimously recommended that the Phase III RESONATE study to compare Imbruvica (ibrutinib) versus GlaxoSmithKline's (LSE:GSK) Arzerra (ofatumumab) should be stopped early because the primary and a key secondary endpoint of the study have been met. Pharmacyclincs’ shares leapt 19% to $124.54 in mid-morning trading yesterday.

The Phase III RESONATE study demonstrated that Imbruvica showed a statistically significant improvement in progression-free survival (the primary endpoint of the study, which was evaluated by an independent review committee) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Further, Imbruvica showed statistically significant improvement in overall survival (a key secondary endpoint of the trial). The global study involved 391 patients at more than 70 clinical sites in 10 countries. The IDMC recommended that the sponsor provide access to Imbruvica for subjects on the ofatumumab arm.

Fong Clow, senior vice president of Biometrics at Pharmacyclics, said: “We are very pleased with the vigilance and professional expertise that our IDMC exercised in monitoring this study. The results seen at the interim analysis of the RESONATE trial are robust and consistent.”