Pharmacyclics' wallet just got a little heavier: the Phase III clinical trial RESONATE™-2 just enrolled its fifth patient, subsequently triggering a fourth $50 million milestone payment obligation from Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
This trial is a randomized, multicenter, open-label Phase III study of ibrutinib (PCI-32765) as a monotherapy versus chlorambucil in patients 65 years or older with treatment-naïve chronic lymphocytic leukemia/small lymphocyctic lymphoma (CLL/SLL). The study is designed to demonstrate superiority of ibrutinib with the primary endpoint of progression-free survival (PFS); the comparator is single-agent chlorambucil. This global study is planned to enroll 272 patients worldwide.
Pharmacyclics entered into a worldwide collaboration with Janssen in December of 2011 to develop and commercialize ibrutinib, an oral Bruton's tyrosine kinase (BTK) inhibitor. Pharmacyclics received from Janssen an up-front payment totaling $150 million upon signing the contract. To date, $200 million in milestones have been earned and Pharmacyclics may receive up to an additional $625 million in development and regulatory milestone payments for total potential up-front and milestone payments of $975 million.
Milestone payments from Janssen to Pharmacyclics have all been triggered by the enrollment of a fifth patient in a clinical trial of ibrutinib. Pharmacyclics also received a $50 million payment from Janssen in early August after the Phase III clinical trial, RESONATE (PCYC-1112), of ibrutinib versus ofatumumab for patients with relapsed or refractory CLL/SLL, enrolled its fifth patient; after, later that month, the clinical trial, SPARK (MCL2001), of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL) enrolled its fifth patient; and after the Phase III clinical trial (CLL3001) of ibrutinib (PCI-32765) in combination with bendamustine and rituximab in patients with relapsed or refractory CLL/SLL enrolled its fifth patient in October.