Johnson & Johnson and AbbVie Inc. said a combination of their drug Imbruvica with Roche Holding AG's Rituxan helped patients with relapsed Waldenström's macroglobulinemia, a certain cancer of the lymph nodes, live significantly longer in a clinical trial.
The trial, also known as iNNOVATE, included patients who had either been previously untreated or had seen their disease relapse or resist treatment. The main goal of the phase 3 study — the last of three stages of human testing usually required for regulatory approval — was to assess how long patients lived without the disease worsening, a measure known as progression-free survival.
Among those who received the combination treatment, 82% had lived without the disease worsening at 30 months, compared with 28% who only received Rituxan.
Secondary goals of the study included the rate of improvement in the disease and improvement in hemoglobin levels from baseline and safety.
A total of 150 patients were randomly assigned oral Imbruvica 420 mg once daily and Rituxan combination or a placebo and Rituxan combination, which saw 28% survive without the disease worsening at 30 months.
The rate of improvement in the disease in the Imbruvica and Rituxan arm was 72%, compared with 32% in the placebo arm of the trial.
In addition, the patients on the Imbruvica-Rituxan combination saw an improvement of 73% in their hemoglobin levels, versus 41% of the patients seeing improvement in the placebo arm of the study.
"The data from this chemotherapy-free combination regimen suggests that patients with Waldenström's macroglobulinemia, including those who are newly diagnosed, could have another beneficial therapeutic option in the future," Thorsten Graef, the head of clinical development at AbbVie's Pharmacyclics unit, said in a statement.
Waldenström's macroglobulinemia, or lymphoplasmacytic lymphoma, is categorized as a type of non-Hodgkin lymphoma, in which the cancer cells produce large amounts of macroglobulin, an abnormal protein.
In December 2017, phase 3 results of Imbruvica in combination with Rituxan met its main goal in patients who have not received prior treatment and were previously treated for Waldenström's macroglobulinemia.
The study showed that the Imbruvica and Rituxan combination worked better compared to rituximab alone.
The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on-site and an additional 3,350 abstracts to be published online.
