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Janssen’s Imbruvica- rituximab combination meets primary end point in phase 3 study

PBR Staff Writer Published 06 December 2017

Janssen Research & Development (Janssen) has announced that the combination of Imbruvica (ibrutinib) and rituximab (Rituxan) has improved progression-free survival (PFS) in patients with Waldenstrom macroglobulinemia (WM) in the Phase 3 iNNOVATE (PCYC-1127) study.

Janssen Biotech, along with AbbVie’s Pharmacyclics, has developed Imbruvica, which is a first-in-class Bruton's tyrosine kinase inhibitor.

iNNOVATE is a Pharmacyclics-sponsored, randomized, placebo-controlled and double-blind study designed to asses Imbruvica in combination with rituximab and placebo in combination with rituximab in 150 patients with relapsed/refractory and treatment-naive WM.

The company has randomized patients to secure intravenous rituximab 375 mg/m2 once weekly for four consecutive weeks. It was followed by a second four-weekly rituximab course and a three-month interval.

All patients secured either Imbruvica 420 mg or placebo once daily continuously until criteria for permanent discontinuation were met, said the company.

PFS was the primary endpoint, with secondary endpoints including overall response rate, hematological improvement measured by hemoglobin, time-to-next treatment, overall survival and safety.

Janssen Oncology late-stage development and global medical affairs vice president Dr Craig Tendler said: “It is gratifying to see that patients with Waldenström’s macroglobulinemia – a rare, difficult-to-treat form of blood cancer – have achieved this magnitude of benefit with the Imbruvica combination with rituximab as compared to rituximab alone in either the relapsed/refractory or newly diagnosed setting.”

In January 2015, Imbruvica secured FDA approval for the treatment of WM.

WM, which is a form of non-Hodgkin’s lymphoma, has been diagnosed in around 1,500 people in the US every year.