Dr. Karmali on the Toxicity Profile of Ibrutinib Maintenance in MCL

Reem Karmali, MD, MS, assistant professor of medicine, Northwestern University Feinberg School of Medicine, discusses the toxicity profile of ibrutinib (Imbruvica) maintenance therapy after induction therapy in patients with mantle cell lymphoma (MCL).

Among the 36 patients who received ibrutinib as maintenance at a dose of 560 mg daily for up to 4 years or until disease progression or unacceptable toxicity, investigators reported toxicities that were in line with what one would expect from ibrutinib's safety profile. Overall, with treatment exposures, patients tolerated the drug quite well, says Karmali. At a follow-up of 19 months, the median number of cycles delivered were 16.5. One-quarter of patients have already completed 2 or more years of ibrutinib maintenance; of these patients, 2 of them have completed the full 4 years of treatment.

Regarding toxicities, approximately two-thirds of patients had treatment-related adverse events that required dose modification. About 20% of patients required a permanent dose modification or reduction and 25% of patients discontinued ibrutinib permanently. Atrial fibrillation was the main cause for discontinuation, and it was reported in 9 patients, concludes Karmali.