THURSDAY, Dec. 14, 2023 (HealthDay News) — For patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), ibrutinib combined with venetoclax provides a progression-free survival benefit, according to a study presented at the annual meeting of the American Society of Hematology, held from Dec. 9 to 12 in San Diego.
Michael Wang, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues randomly assigned patients with R/R MCL after one to five prior therapies to receive ibrutinib-venetoclax or ibrutinib-placebo for two years (134 and 133 patients, respectively).
The researchers found that at a median of 51.2 months, median progression-free survival by investigator assessment was significantly longer with ibrutinib-venetoclax than ibrutinib-placebo (31.9 versus 22.1 months; hazard ratio, 0.56). At 24 months, the progression-free survival rates were 57 and 45 percent with ibrutinib-venetoclax and ibrutinib-placebo, respectively. The benefit in progression-free survival seen with ibrutinib-venetoclax was generally consistent across subgroups, including those with blastoid variant or TP53-mutated MCL. The results of sensitivity analyses were consistent with those of the primary analysis. Significant improvement in complete response rates (54 versus 32 percent) and time to next treatment (median, not reached versus 35.4 months) was also seen for ibrutinib-venetoclax versus ibrutinib-placebo. Grade ≥3 adverse events occurred in 84 and 76 percent of patients with ibrutinib-venetoclax and ibrutinib-placebo, respectively; in 60 percent of patients in each arm, serious adverse events occurred.
“Overall, these results demonstrate a favorable benefit-risk profile for ibrutinib-venetoclax in patients with R/R MCL,” the authors write.
Several authors disclosed ties to the biopharmaceutical industry.
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