Posted: Friday, June 3, 2022
In the multicenter phase III SHINE trial, first-line treatment with the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib plus bendamustine and rituximab followed by maintenance therapy with rituximab significantly improved progression-free survival versus chemoimmunotherapy in older patients with mantle cell lymphoma. The primary results, which were presented by Michael Wang, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA7502), identified no new safety signals. These findings were also simultaneously published in The New England Journal of Medicine.
Patients with a median age of 71 years were randomly assigned in a 1:1 ratio to receive bendamustine plus rituximab in combination with ibrutinib (n = 261) or a placebo (n = 262). Those who achieved an objective response underwent maintenance therapy with rituximab.
Based on these primary results, ibrutinib significantly improved progression-free survival versus the placebo (P = .011). The median duration of progression-free survival following maintenance therapy was 80.6 months with ibrutinib and 52.9 months with the placebo. The complete response rates were 65.5% and 57.6% with ibrutinib and the placebo, respectively (P = .0567). Overall survival did not significantly differ between the arms (P = .648). The time to next treatment was longer with ibrutinib than with the placebo (P < .001). Subsequent antilymphoma therapy was administered in 19.9% and 40.5% of the ibrutinib and placebo arms, respectively; 38.7% of the placebo arm underwent second-line BTK inhibition.
The rate of grade 3 or 4 treatment-emergent adverse events was 81.5% with ibrutinib and 77.3% with the placebo. Atrial fibrillation, an adverse event of clinical interest, was reported in 13.9% of patients treated with ibrutinib and 6.5% of those treated with the placebo. The study authors reported that quality of life did not differ between the arms, nor did the rates of major hemorrhage, hypertension, arthralgia, or secondary primary malignancies.
Disclosure: For full disclosures of the study author, visit coi.asco.org.