The following is a summary of “Overall Survival With Daratumumab, Lenalidomide, and Dexamethasone in Previously Treated Multiple Myeloma (POLLUX): A Randomized, Open-Label, Phase III Trial,” published in the March 2023 issue of Oncology by Dimopoulos, et al.
For a study, researchers sought to report on the updated results of the POLLUX study, which is a phase III, multicenter, randomized, open-label study that evaluated the efficacy and safety of daratumumab in combination with lenalidomide and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) alone in patients with relapsed or refractory multiple myeloma (RRMM).
The study enrolled patients with ≥ 1 prior line of therapy and randomly assigned them to receive either D-Rd or Rd until disease progression or unacceptable toxicity. The initial analysis of the study showed that D-Rd significantly prolonged progression-free survival compared to Rd alone. In this updated analysis, the researchers report on the study’s overall survival (OS) data.
In patients with relapsed or refractory multiple myeloma (RRMM), combining daratumumab with lenalidomide and dexamethasone (D-Rd) led to a significant overall survival (OS) benefit. This was observed with a hazard ratio of 0.73 and 95% CI of 0.58 to 0.91, and a P value of 0.0044 at a median follow-up of 79.7 months (range of 0.0 to 86.5 months). The median OS was 67.6 months for D-Rd and 51.8 months for Rd alone.
Pre-specified analyses showed that D-Rd improved OS compared to Rd in most subgroups, including patients ≥65 years or older, those with one to three prior lines of therapy, International Staging System stage III disease, high-risk cytogenetic abnormalities, and those who were refractory to their last prior line of therapy or a proteasome inhibitor. The most common treatment-emergent adverse events of grade 3/4 severity (≥10%) with D-Rd compared to Rd were neutropenia (57.6% vs 41.6%), anemia (19.8% vs 22.4%), pneumonia (17.3% vs 11.0%), thrombocytopenia (15.5% vs 15.7%), and diarrhea (10.2% vs 3.9%).
The researchers concluded that the updated results from the POLLUX study show that D-Rd significantly extended OS compared to Rd alone in patients with RRMM. The study’s findings, together with the OS benefit observed with daratumumab plus bortezomib and dexamethasone in the phase III CASTOR trial, demonstrated OS improvement with daratumumab-containing regimens in RRMM.
Reference: ascopubs.org/doi/full/10.1200/JCO.22.00940