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The phase III POLLUX (NCT02076009) study, comparing the efficacy of lenalidomide and dexamethasone (Rd) to that of Rd combined with daratumumab (DRd), has uncovered the promising clinical activity of DRd in patients with relapsed or refractory (R/R) multiple myeloma (MM; RRMM). Combination of the anti-CD38 monoclonal antibody, daratumumab, with the Rd regimen demonstrated favorable progression free survival (PFS) and overall response rates (ORR) in RRMM.1 In September 2018, the MM Hub reported the interim results from POLLUX study, which highlighted the potential of DRd. Nizar J Bahlis, Charbonneau Cancer Research Institute, University of Calgary, Calgary, CA, and colleagues recently published results from a long-term efficacy and safety analysis of POLLUX after a median follow-up of more than 3.5 years.2
Table 1. Median PFS by subgroup2
HR, hazard ratio; ITT, intention to treat; MRD, minimal residual disease; NE, not estimable; NR, not reached; PFS, progression-free survival |
||||
Median PFS, months |
DRd |
Rd |
HR (95% CI) |
p value |
---|---|---|---|---|
ITT population n: 286 vs 283 |
44.5 |
17.5 |
0.44 (0.35–0.55) |
< 0.0001 |
One prior therapy n: 149 vs 146 |
NR |
19.6 |
0.42 (0.30–0.58) |
< 0.0001 |
One–three prior therapies n: 272 vs 264 |
44.5 |
17.5 |
0.43 (0.34–0.54) |
< 0.0001 |
Prior lenalidomide therapy n: 50 vs 50 |
38.8 |
18.6 |
0.38 (0.21–0.66) |
0.0004 |
Refractory to bortezomib n: 59 vs 58 |
34.3 |
11.3 |
0.40 (0.24–0.67) |
0.0003 |
MRD negative |
NR |
42.0 |
0.46 (0.19–1.08) |
0.0667 |
MRD positive |
29.4 |
16.0 |
0.60 (0.48–0.76) |
< 0.0001 |
DRd significantly prolonged PFS compared to Rd in all patient subgroups, while demonstrating a 56% reduction in the risk of disease progression or death at the 3.5-year follow-up. The greatest clinical benefit of DRd was observed in patients that had received one prior line of therapy, supporting the use of DRd in patients with RRMM after first relapse. The safety profile of DRd remains as described in the 2018 analysis with no additional concerns, and DRd continues to produce favorable clinical outcomes in patients with RRMM.
Whilst the POLLUX study is comparing the Rd regimen to DRd, the phase III CASTOR study is comparing bortezomib and dexamethasone (Vd) to daratumumab and Vd (DVd). The MM Hub recently covered an age subgroup analysis from both trials, which is available here.
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