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Jeremy S. Abramson, MD, MMSc
Jeremy S. Abramson, MD, MMSc
Posted: Tuesday, January 21, 2025
David John Lewis, MD, of University Hospitals Plymouth NHS Trust, United Kingdom, and colleagues reportedly performed the first open-label, randomized, phase II/III trial comparing ibrutinib plus rituximab vs rituximab plus chemotherapy in elderly patients with treatment-naive mantle cell lymphoma. Presented during the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 235), the results suggest that ibrutinib plus rituximab may be superior to rituximab plus chemotherapy in this patient population.
“Hematological toxicity was lower with ibrutinib/rituximab, and quality-of-life scores were improved at midtreatment,” concluded the study authors. “Ibrutinib/rituximab is the first nonchemotherapy approach to demonstrate superiority over rituximab/chemotherapy and should be considered a standard of care for first-line treatment for older patients with mantle cell lymphoma.”
The ENRICH trial enrolled 397 patients with untreated stage II to IV mantle cell lymphoma who were at least 60 years old; the median patient age was 74. Participants were randomly assigned 1:1 to receive ibrutinib plus rituximab (n = 199) or rituximab plus chemotherapy (n = 198) until unacceptable toxicity or disease progression. Chemotherapy included rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n = 53) or bendamustine plus rituximab (BR; n = 145).
The median follow-up was 47.9 months. Progression-free survival was significantly improved in the ibrutinib arm compared with the chemotherapy arm (P = .003), according to the investigators. Of note, there was a significant correlation between chemotherapy choice and treatment effect (P = .004). Overall survival was similar between the ibrutinib/rituximab and rituximab/chemotherapy arms at 57.7% and 54.5%, respectively.
Grade 3 or higher nonhematologic adverse events were reported in more than half of patients in the ibrutinib/rituximab (61.1%), R-CHOP (51.9%), and BR (51.7%) subgroups. The R-CHOP arm (50.0%) experienced the most severe hematologic events, followed by the BR (33.6%) and ibrutinib/rituximab (16.7%) arms. Of note, COVID-19 was responsible for 19 and 14 deaths in the ibrutinib and chemotherapy arms, respectively.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
2024 ASH Annual Meeting & Exposition
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