Michael Wang, MD, gives a brief overview of the safety and efficacy findings of a phase 1b study evaluating acalabrutinib plus venetoclax and rituximab in patients with mantle cell lymphoma.
Michael Wang, MD, a professor in the department of lymphoma and myeloma at MD Anderson Cancer Center, gives a brief overview of the safety and efficacy findings of a phase 1b study (NCT02717624) evaluating acalabrutinib (Calquence) plus venetoclax (Venclexta) and rituximab (Rituxan) in patients with mantle cell lymphoma (MCL).
In this ongoing, multicenter, open-label study, 21 patients with MCL were administered the triplet combination to evaluate whether it can improve upon frontline convention chemoimmunotherapy in an elderly patient population.
Findings showed that the combination was safe and well tolerated with the most common grade 1 or 2 side effects including diarrhea, headache, and fatigue. Besides diarrhea, no grade 3 or 4 toxicities were reported and while bleeding occurred in 33% of patients, it was either grade 1 or 2.
0:08 | What is striking and noteworthy for this study in that number 1, the combination is very safe. The patients tolerated the therapy very well. There are no toxins deaths. Unfortunately, 4 patients died from COVID without any relationship to our study therapy. The other issue is that the efficacy is very, very high. One hundred percent of our patients responded to therapy, and the complete response rate by PET scan was 90%.
0: 39 | The study therapy was tolerated very well. The most common side effects included diarrhea, headache, and fatigue, but the majority of those side effects are grade 1 or 2. There's hardly any grade 3 or 4 toxicities except diarrhea.
1:00 | With ibrutinib, we are always concerned about atrial fibrillation. However, among the 21 patients, none of the patients had atrial fibrillation with the study combination. Bleeding occurred in 33% of patients and they were all grade 1 or grade 2, there were no grade 3 or 4 bleeding. Therefore, there was no severe bleeding.