Next Steps for Acalabrutinib in MCL


The results of a phase 1b trial looking at the use of acalabrutinib for patients with treatment-naive or relapsed/refractory mantle cell lymphoma has provided the support needed for the phase 3 ECHO study of this treatment.

Tycel Phillips, MD, a hematologist/oncologists in the Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, and associate professor at the City of Hope National Medical Center in Duarte, California, discusses the next steps for the use of the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence) for patients with treatment-naive or relapsed/refractory mantle cell lymphoma (MCL).

In combination with bendamustine (Bendeka) and rituximab (Rituxan), acalabrutinib was found to be safe with no new safety signals found on the phase 1b (NCT02717624) study, according to data presented at the 2023 ASCO Annual Meeting. In an interview with Targeted OncologyTM, Phillips discussed that no cardiac events of note were seen with the combination, but that by combining acalabrutinib and bendamustine rituximab there is a greater risk of infection due to the immunosuppressive events with the agents, however, they did not see any new signals. Moreover, early responses showed that nearly 80% of patients in the treatment naive cohort had a complete response to the combination.

According to Phillips, these results proved the basis for the phase 3 ECHO trial (NCT02972840) that is looking at a wider patient population on the triplet therapy compared to bendamustine rituximab alone. Here, he discusses these next steps for the BTK inhibitor and what it means for patients with MCL.


0:08 | After this study completed, there was a launch of a phase 3 trial called ECHO, which evaluated bendamustine rituximab and acalabrutinib versus bendamustine rituximab for untreated patients with MCL who were 65 [years of age or older] who are typically considered to be ineligible for ASCT consolidation. That study did allow crossover for those in the bendamustine arm to crossover at disease progression to receive single agent acalabrutinib.

0:25 | At this point, we're just waiting to read out from that study, because that has been closed for a couple years just to see if this was a positive study or not. That takes on quite a bit more importance given what happened with the SHINE study [NCT01776840], which looked at a very similar BTK inhibitor in frontline MCL that ultimately led to the removal of that drug in the relapsed refractory setting.

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