APOLLO Study Results Are Presented at ASH 2021

Daratumumab plus pomalidomide and dexamethasone shows benefits for patients with relapsed or refractory multiple myeloma who are refractory to lenalidomide, compared with pomalidomide and dexamethasone therapy alone, according to new study results presented at the American Society of Hematology’s 2021 Annual Meeting and Exposition.

The APOLLO study was a phase 3 trial comparing pomalidomide and dexamethasone therapy with daratumumab as an add-on therapy in patients with relapsed or refractory multiple myeloma who were refractory to other therapies.

To conduct the study, the researchers enrolled patients who were at least 18 years of age, had refractory multiple myeloma, had received at least 1 prior line of therapy, and had responded to prior treatment. Participants were then randomly assigned 1:1 to receive either pomalidomide and dexamethasone therapy alone or pomalidomide and dexamethasone plus daratumumab. The group receiving daratumumab received the treatment subcutaneously or intravenously weekly in cycles 1 and 2, every 2 weeks in cycles 3 to 6, and every 4 weeks after that. The primary endpoint was progression-free survival. Therefore, patients received treatment until their disease progressed or they achieved acceptable toxicity.

After a median follow-up period of 16.9 months, the progression-free survival rate was higher in the daratumumab add-on group vs the pomalidomide and dexamethasone group (12.4 months vs 6.9 months).

Daratumumab also prolonged the estimated 18-month progression-free survival rate (42.1% vs 25.5%) and prolonged survival among patients who were refractory to lenalidomide, regardless of when they had received their last dose.

The most frequently reported adverse events were neutropenia, thrombocytopenia, and anemia.

“The safety profile observed in the APOLLO trial was consistent with previous reports for [daratumumab subcutaneous and pomalidomide and dexamethasone],” the researchers concluded. “Additional analyses for lenalidomide-refractory patients, as well as efficacy and safety data for the overall population at longer follow up, will be presented.”

—Amanda Balbi

Reference

Sonneveld P, Terpos E, Boccadoro M, et al. Pomalidomide and dexamethasone with or without subcutaneous daratumumab in patients with relapsed or refractory multiple myeloma: updated analysis of the phase 3 Apollo study. Paper presented at: American Society of Hematology’s 2021 Annual Meeting and Exposition; December 11-14, 2021; Virtual. https://ash.confex.com/ash/2021/webprogram/Paper146907.html