DREAMM-8 Trial: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone Significantly Improves PFS in Multiple Myeloma
核心洞察
The DREAMM-8 trial evaluated belantamab mafodotin, pomalidomide, and dexamethasone (BPd) versus pomalidomide, bortezomib, and dexamethasone (PVd) in relapsed/refractory multiple myeloma (搜索) patients.
BPd demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to PVd (HR, 0.52; 95% CI, 0.37-0.73; P < .001).
The overall response rate was higher in the BPd arm (77%) compared to the PVd arm (72%), with deeper responses observed, including higher rates of complete response or better (40% vs 16%).
The phase 3 DREAMM-8 trial (NCT04484623) has demonstrated that the combination of belantamab mafodotin-blmf (Blenrep), pomalidomide (Pomalyst), and dexamethasone (BPd) significantly improves progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma (搜索) who have received one to three prior lines of therapy. The study, presented by Dr. Meletios (Thanos) Dimopoulos, highlights a clinically meaningful advancement in the treatment of this challenging disease.
The DREAMM-8 trial randomly assigned patients to receive either BPd or pomalidomide, bortezomib (Velcade), and dexamethasone (PVd). A key inclusion criterion was prior treatment with lenalidomide, reflecting current clinical practice where lenalidomide maintenance therapy is common. Notably, 23% and 27% of patients in the BPd and PVd arms, respectively, had also received prior treatment with the anti-CD38 monoclonal antibody daratumumab.
The primary endpoint of PFS was met with striking results. Patients in the BPd arm achieved a median PFS that was not reached, compared to 12.7 months (95% CI, 9.1-18.5) in the PVd arm (HR, 0.52; 95% CI, 0.37-0.73; 2-sided P < .001). This PFS improvement was not only statistically significant but also considered clinically meaningful by Dr. Dimopoulos.
Response Rates and Depth of Response
Beyond PFS, the study also revealed deeper responses in the BPd arm. The overall response rate (ORR) was 77% (95% CI, 70%-84%) in the BPd arm versus 72% (95% CI, 64%-79%) in the PVd arm. More significantly, the complete response (CR) or better rates were 40% (95% CI, 32%-48%) and 16% (95% CI, 11%-23%) in the BPd and PVd arms, respectively. Furthermore, 24% (95% CI, 17%-31%) of patients in the BPd arm achieved a CR or better plus minimal residual disease (MRD) negativity, compared to only 5% (95% CI, 2%-10%) in the PVd arm.
Duration of Response
The estimated percentages of patients with a duration of response of 12 months were 79% (95% CI, 71%-86%) in the BPd arm versus 61% (95% CI, 50%-70%) in the PVd arm, indicating a more sustained treatment effect with the belantamab mafodotin combination.