DREAMM-8 Study Subgroup Analysis Released: MM with High-Risk Cytogenetic Features

The DREAMM-8 study has compared belantamab mafodotin plus pomalidomide and dexamethasone (BPd) with pomalidomide plus bortezomib and dexamethasone (PVd) as treatments for relapsed or refractory multiple myeloma (MM).

A subgroup analysis has been performed in this study of patients with high-risk cytogenetic abnormalities (HRCAs). Its results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, Illinois, by first author Suzanne Trudel, MD, of Princess Margaret Cancer Centre in Toronto, Ontario, Canada.

In their analysis, Trudel and colleagues observed in these patients that “BPd demonstrated clinically meaningful PFS [progression-free survival] benefit, higher ORR [overall response rate], and a higher rate of deep responses vs PVd. These data support the potential use of BPd as a standard-of-care regimen in this key pt [patient] population with a high unmet need.”

The intention-to-treat population in DREAMM-8 included 302 patients who had received at least one prior line of MM therapy, including lenalidomide. After randomization, 155 patients were administered BPd in 28-day cycles, and 147 were administered PVd in 21-day cycles. The patients received treatment until unacceptable toxicity, disease progression, or death occurred.

For the subgroup analysis, patients were identified as having an HRCA if they had at least one of the following: t(4;14), t(14;16), amp1q, or del(17p13). According to these criteria, 44% of the patients who received BPd and 41% of the patients who received PVd had HRCAs. In the BPd arm, 15% of all patients had t(4;14), 5% had t(14;16), 26% had amp1q, and 21% had del(17p13). In the PVd arm, 14% of all patients had t(4;14), 7% had t(14;16), 22% had amp1q, and 18% had del(17p13).

The median PFS for patients with at least one HRCA was calculated to be 21.1 months among BPd recipients versus 9.2 months among PVd recipients, with a hazard ratio (HR) of 0.58. The 18-month PFS rate for patients with at least one HRCA was calculated to be 53% among BPd recipients versus 33% among PVd recipients. By HRCA subgroup, BPd was found to have a PFS benefit advantage over PVd in t(14;14), amp1q, and del(17p13), with calculated HRs of 0.74, 0.49, and 0.45, respectively.

Patients with at least one HRCA were found to have a higher ORR with BPd than with PVd, at 76% versus 65%, respectively. The patients with at least one HRCA in the BPd arm more often achieved a complete response (CR) or better than did those in the PVd arm, with frequencies of 43% versus 15%, respectively. BPd was also found to have an advantage over PVd in achievement of CR or better in patients with t(4;14), t(14;16), amp1q, or del(17p13), calculated at 39% versus 25%, 43% versus 18%, 43% versus 9%, and 34% versus 0%, respectively.