Patients with relapsed or refractory mantle cell lymphoma have a better quality of life with Imbruvica (ibrutinib) than Torisel (temsirolimus), a Phase 3 clinical trial suggests.
The finding was published in the journal Leukemia & Lymphoma. The title of the study was “Health-related quality-of-life data from a phase 3, international, randomized, open-label, multicenter study in patients with previously treated mantle cell lymphoma treated with ibrutinib versus temsirolimus.”
Mantle cell lymphoma, or MCL, is an aggressive B-cell malignancy with no cure. Fewer than 50 percent of patients achieve a complete response to current therapies, with the duration of response generally ranging from 18 months to three years.
The Phase 3 RAY trial (NCT01646021) assessed the safety and effectiveness of Imbruvica, compared with Torisel . Previous studies had shown that Torisel increased the time it took for a patient’s disease to progress or a patient to die, compared with a therapy of investigators’ choice.
The Imbruvica versus Torisel study included 253 patients, 130 of whom received Imbruvica and 123 Torisel. Imbruvica reduced the risk of disease progression or death by 57 percent compared with Torisel, according to the trial results – a showing considered statistically significant,
In addition, the trial showed that Imbruvica improved patients’ lymphoma symptoms, and did so faster than Torisel.
Researchers presented long-term results of the RAY trial at the International Conference on Malignant Lymphoma in Lugano, Switzerland, June 18-22.
Patients treated with Imbruvica lived a median of more than two years without their disease progressing, four times longer than those in the Torisel group, the team said. Their presentation was titled “Ibrutinib vs Temsirolimus: Three-Year Follow-Up of Patients with Previously Treated Mantle Cell Lymphoma From the Phase 3, International, Randomized, Open-Label Ray Study,”
Researchers also decided to assess Imbruvica’s impact on patients’ quality of life, which they see as an additional measure of its effectiveness.
The yardsticks they used were patients’ scores on two questionnaires, the Functional Assessment of Cancer Therapy-Lymphoma, or FACTLym, and EQ-5D-5L.
In both surveys, patients on Imbruvica reported greater improvements in their health-related quality of life than those on Torisel.
“A drug therapy must strike a balance that prevents or slows disease progression while keeping symptomatic toxicity at a manageable level,” the researchers wrote.
“This analysis demonstrates that the responses seen after [Imbruvica] therapy translate to a subjectively experienced benefit for the patient that is quickly observed. Additionally, patients on [Imbruvica] are achieving their response without the cost” of reduced well-being.
The study suggested that Imbruvica can help fight relapsed or refractory MCL, while maintaining or improving patients’ quality of life.
