Ibrutinib: Phase II started
Pharmacyclics enrolled the fifth patient in the open-label, international Phase II SPARK trial evaluating 560 mg once-daily oral ibrutinib in about 110 MCL patients who have received >=1 prior rituximab-containing chemotherapy regimen and who have progressed after bortezomib therapy. The enrollment triggered a $50 million milestone payment to Pharmacyclics from Johnson & Johnson's Janssen Biotech Inc. unit under a 2011 deal to co-develop and co-commercialize Pharmacyclics' ibrutinib (see BioCentury, Dec. 12, 2011). Pharmacyclics is eligible for an additional $725 million in development and regulatory milestones from Jansse, including $50 million milestone payments for enrolling the fifth patient in each Phase III trial of ibrutinib in specific indications. Earlier this month, Pharmacyclics triggered a $50 million payment by enrolling the fifth patient in the Phase III RESONATE trial of ibrutinib to treat chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma. ...