At the 65th ASH Annual Meeting in San Diego, California, Craig A Portell, MD, University of Virginia Medical Center, Charlottesville, Virginia, assessed the potential benefit of bendamustine, rituximab, and venetoclax as an initial treatment among older patients with mantle cell lymphoma, noting the combination shows promise, but there is a need for longer follow-up to further evaluate. 

Transcript: 

Hi, my name is Craig Portell. I'm an associate professor of medicine at the University of Virginia, and I'm presenting a study through the PrECOG study group. 

The PrECOG 0405 study was an upfront treatment for mantle cell lymphoma patients who were older than the age of 60. It used bendamustine and rituximab in the standard treatment. Patients who were over the age of 75 [were allowed to] to receive a lower dose of bendamustine at 70 milligrams per meter squared. All other patients received 90 milligrams per meter squared of bendamustine.

Venetoclax was titrated with the first cycle with those standard weekly ramp up and then subsequent cycles. It was given at 400 milligrams daily for only 10 days and then repeated every 28 days. We found a very promising overall response rate of 97% with a complete response (CR) rate, which was confirmed by both [positron emission tomography] (PET), [computed tomography] (CT), and bone marrow biopsy in those patients who had bone marrow involvement at enrollment. That CR rate was 85%. 

The treatment was generally well tolerated. We saw some nausea as well as some neutropenia. However, there was no febrile neutropenia during the induction chemotherapy. Maintenance was allowed in the study, per investigator discretion. About 20 of the 33 subjects did get maintenance-rituximab, and we did see some COVID-related issues in the study. 

This study did enroll at the height of the COVID pandemic, from January 2020 to March 2022. We did see 4 COVID-related deaths in patients who were in remission after induction. None of those patients had received maintenance rituximab, so we do not think that maintenance rituximab was a contributor to this. However, we have seen this issue with other studies, and therefore it's uncertain how venetoclax relates to that. 

Overall, the study was very promising. It seemed to be very well tolerated and had a high response rate, with a complete response rate of 85%.

Source:

Portell CA, Jegede O, Bennani NN, et al. Primary analysis and results of bendamustine, rituximab, and venetoclax (BR-VEN) for initial treatment of mantle cell lymphoma in subjects over 60 years of age (PrE0405). Presented at the ASH 65th Annual Meeting & Exposition; December 9-12 2023; San Diego, California. Abstract 733