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ICML 2025 | Acalabrutinib in combination with rituximab & lenalidomide in R/R follicular lymphoma
Paolo Strati, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses the findings from a Phase I trial investigating the combination of acalabrutinib, rituximab, and lenalidomide in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The combination showed a response rate of over 80% and a one-year progression-free survival (PFS) rate of over 70%. This interview took place during the 18th International Conference on Malignant Lymphoma (18-ICML) in Lugano, Switzerland.
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Transcript
So we recently published the results of a multi-center industry-initiated Phase I trial looking into the safety and efficacy of acalabrutinib in combination with rituximab and lenalidomide in 29 patients with relapsed/refractory follicular lymphoma. Two dose levels were investigated: 15 and 20 milligrams by mouth on day one to day 21 of a 28-day cycle. No DLT was observed and the highest dose level, so 20 milligrams, was actually the recommended Phase II dose that we ended up exploring...
So we recently published the results of a multi-center industry-initiated Phase I trial looking into the safety and efficacy of acalabrutinib in combination with rituximab and lenalidomide in 29 patients with relapsed/refractory follicular lymphoma. Two dose levels were investigated: 15 and 20 milligrams by mouth on day one to day 21 of a 28-day cycle. No DLT was observed and the highest dose level, so 20 milligrams, was actually the recommended Phase II dose that we ended up exploring. In terms of toxicity, as I mentioned, there was no DLT and overall treatment emergent adverse events didn’t seem to be synergistic in terms of toxicity, as we also eventually saw in the Phase II in previously untreated. But most importantly, even though this was a Phase 1 trial and of course mainly focused on safety and tolerability, efficacy was quite promising. Response rate was higher than 80% and one year PFS rate was higher than 70%. We were also able in that trial to look into minimal residual disease utilizing a CAPP-Seq like type of panel and there was actually significant reduction in circulating tumoral DNA with MRD negative cases that very nicely correlated with relapse-free survival.
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