Ibrutinib-Based Combination Therapy Demonstrates Over Two-Year Improvement in Progression-Free Survival for Elderly Mantle Cell Lymphoma Patients

Recently, Janssen, a subsidiary of Johnson & Johnson, announced that adding the Bruton's tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) to maintenance therapy consisting of bendamustine-rituximab (BR) and rituximab reduced the risk of disease progression or death by 25% in newly diagnosed mantle cell lymphoma (MCL) patients over 65 years old. These results were published today in The New England Journal of Medicine and presented as an oral report at the ASCO Annual Meeting.

MCL is an aggressive rare non-Hodgkin lymphoma (NHL) that affects people over 65. They usually cannot tolerate intensive chemoimmunotherapy and stem cell transplantation, leading to poor clinical outcomes. These patients need new treatment options.

Imbruvica is an oral BTK inhibitor jointly developed by Janssen and Pharmacyclics, a subsidiary of AbbVie. BTK plays a crucial role in the survival and proliferation of both normal and malignant B cells. Imbruvica has been approved in more than 100 countries and regions worldwide, treating over 250,000 patients globally.

In the Phase 3 clinical trial named SHINE, at a median follow-up time of 84.7 months, the Imbruvica combination therapy group showed a median progression-free survival (PFS) of 6.7 years, which is 2.3 years longer than the control group (4.4 years), demonstrating clinical significance.

Key secondary endpoints included complete response, overall survival, and overall response rate, among others. The complete response rate in the Imbruvica group was 65.5%, compared to 57.6% in the control group. The objective response rates were similar between the two groups. The overall survival was also similar, with the median overall survival not yet reached in either group.

"The prognosis of elderly MCL patients urgently needs improvement," said Professor Michael L. Wang from the Department of Lymphoma and Myeloma at MD Anderson Cancer Center. "The 6.7-year progression-free survival data indicate that the Imbruvica combination therapy has the potential to become a first-line treatment for this patient population."

References:

[1] Phase 3 SHINE Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma. Retrieved June 3, 2022, from https://www.janssen.com/phase-3-shine-results-show-imbruvicar-ibrutinib-based-combination-regimen-significantly-reduced-risk

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