FDA approves triplet of D-Rd for patients with NDMM who are not eligible for ASCT 

The United States (US) Food & Drug Administration (FDA) has approved the use of daratumumab (D), lenalidomide (R) and dexamethasone (d; D-Rd) in patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).^1-3

The approval is based on the results of the phase III MAIA study (MMY 3008) which compared D-Rd to Rd alone. The interim results of the study were presented by Thierry Facon during the late breaking abstracts session at the 60^th American Society of Hematology (ASH) meeting in San Diego, CA, in December 2018.⁴

Whilst this brings a new option to patients with non-transplant eligible NDMM in the US, this regimen is not yet approved in Europe, though a type II variation application was previously submitted to the European Medicines Agency (EMA).⁵

MAIA trial results^4,5

The phase III MAIA trial compared D-Rd (n = 368) to Rd alone (n = 369) in patients with NDMM who were not candidates for ASCT. The primary endpoint of the study was progression-free survival (PFS).

At a median follow-up of 28 months, the PFS rate for the D-Rd arm was not reached (NR), compared to 31.9 months for the Rd arm. The D-Rd regimen gave a 44% reduction in the risk of progression or death with a higher rate of minimal residual disease (MRD) negativity (10^-5) which was 24% with D-Rd arm versus 7% with Rd (P < 0.0001). Table 1 shows a further breakdown of results.

Overall, the D-Rd triplet led to deeper responses, a three-fold higher MRD negativity rate, and had a comparable safety profile to that reported in other studies such as POLLUX and ALYCONE.

Table 1: Summary of MAIA clinical trial^4,5

Read the full results reported during the ASH 2018 meeting here.