The co-marketers of Imbruvica® (ibrutinib), AbbVie and Janssen (Johnson & Johnson), said that the FDA has approved their drug in combination with the Genentech/Biogen co-marketed Rituxan® (rituximab) as the first non-chemotherapy combination treatment for the rare blood cancer Waldenström’s macroglobulinemia (WM).
The approval marks the ninth FDA authorization since November 2013 for Imbruvica, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor developed and commercialized by Janssen Biotech and Pharmacyclics. AbbVie acquired Pharmacyclics for $21 billion in a deal completed in May 2015 and announced in March 2015, two months after Imbruvica was approved as a monotherapy for WM.
“Today’s approval represents an important milestone for people living with this rare and incurable blood cancer who have limited FDA-approved treatment options,” Andree Amelsberg, M.D., vp of oncology medical affairs at Janssen Scientific Affairs, said in a company statement. “We remain dedicated to a comprehensive clinical development program to explore the full potential of Imbruvica, including in combination with other therapies.”
Rituxan is the first monoclonal antibody to win FDA approval as a cancer treatment, with the agency granting a Biogen predecessor company, Idec Pharmaceuticals, and Genentech (now a member of the Roche companies) its first authorization for the drug in November 1997, for relapsed or refractory, CD-20 positive, B-cell, low-grade or follicular non-Hodgkin’s lymphoma. Rituxan was the first single agent approved specifically for therapy of a lymphoma. Biogen acquired Idec for approximately $6.8 billion in 2003.
The FDA based its approval on positive results from the Phase III iNNOVATE trial (NCT02165397). The randomized, double-blind, placebo-controlled study was designed to assess Imbruvica in combination with Rituxan versus placebo plus Rituxan in 150 patients with either relapsed/refractory (r/r) disease or previously untreated WM.
At 30 months following treatment, a progression-free survival (PFS) rate of 82% was reported in patients randomized to Imbruvica plus Rituxan, compared to just 28% for patients treated with placebo plus Rituxan. Patients treated with Imbruvica plus Rituxan also experienced an 80% reduction in relative risk of disease progression or death compared with participants who were only treated with Rituxan, Janssen said.
“Based on these results, Imbruvica in combination with rituximab may be considered as a first- and second-line option for appropriate people diagnosed and living with WM,” iNNOVATE lead study investigator Meletios A. Dimopoulos, M.D., professor and chairman of the department of clinical therapeutics, National and Kapodistrian University of Athens School of Medicine, said in Janssen’s statement.
According to Janssen, iNNOVATE—also known as PCYC-1127—was the largest Phase III study of a non-chemotherapy combination in WM patients. Data from iNNOVATE were simultaneously published in The New England Journal of Medicine and presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting, held in Chicago.