ORLANDO – Patients with relapsed multiple myeloma and high- or standard-risk cytogenetics treated with carfilzomib plus dexamethasone had a clinically meaningful improvement in progression-free survival compared with patients treated with bortezomib plus dexamethasone, a study presented at the 57th American Society of Hematology (ASH) Annual Meeting & Exposition has shown.1
The phase 3 ENDEAVOR study previously demonstrated a clinically meaningful and statistically significant improvement in median progression-free survival in patients with relapsed myeloma treated with carfilzomib plus dexamethasone vs bortezomib plus dexamethasone (HR, 0.53; 95% CI, 0.44 – 0.65; P < .0001).
In this subgroup analysis, researchers report the efficacy and safety of carfilzomib plus dexamethasone compared with bortezomib plus dexamethasone with regard to baseline cytogenetic risk status.
In the ENDEAVOR study, a total of 929 patients were randomly assigned 1:1 to each treatment arm, with baseline cytogenetic risk status well-balanced between the groups.
Results of the subgroup analysis showed that median progression-free survival for patients with high-risk cytogenetics was 8.8 months with carfilzomib and 6.0 months with bortezomib (HR, 0.646; 95% CI, 0.453 – 0.921). For standard-risk patients, median progression-free survival was not evaluable in the carfilzomib treatment arm and 10.2 months in bortezomib arm (HR, 0.439; 95% CI, 0.333 – 0.578).
“As expected, median progression-free survival for patients with high-risk cytogenetics was lower as compared with the overall population,” Meletios A. Dimopoulos, MD, professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine in Athens, Greece, said during his presentation.
“However, patients treated with Kd had a clinically meaningful improvement in progression-free survival compared with Vd in patients with high- or standard-risk cytogenetics.”
Furthermore, overall response rate was 72.2% (95% CI, 62.1 – 80.8) with carfilzomib and 58.4% (95% CI, 48.8 – 67.6) with bortezomib among patients with high-risk cytogenetics, and 79.2% (95% CI, 74.0 – 83.8) vs 66.0% (95% CI, 60.2 – 71.4), respectively, among those with standard-risk cytogenetics.
In terms of safety, the incidence of grade 2 or higher peripheral neuropathy was lower in the carfilzomib group than bortezomib group among both patients with high- and standard-risk cytogenetics. “The most common infection was pneumonia,” Dr Dimopoulos noted.
RELATED: Adding Bortezomib to Lenalidomide, Dex Improves Survival in Previously Untreated Myeloma
The findings suggest that carfilzomib plus dexamethasone was superior to bortezomib plus dexamethasone regardless of baseline cytogenetic risk status in patients relapsed multiple myeloma.
“Kd had a favorable benefit-risk profile in patients with high-risk relapsed multiple myeloma and was superior to Vd, regardless of baseline cytogenetic risk status,” Dr Dimopoulos concluded.
- Chng W-J, Goldschmidt H, Dimopoulos MA, et al. Efficacy and safety of carfilzomib and dexamethasone vs bortezomib and dexamethasone in patients with relapsed multiple myeloma based on cytogenetic risk status: subgroup analysis from the phase 3 study Endeavor (NCT01568866). Oral presentation at: 57th American Society of Hematology (ASH) Annual Meeting & Exposition; December 5-8, 2015; Orlando, FL.