Prodotti competitors / Area Kite
Phase 3 CERVINO Meets Dual Primary Endpoints for Etentamig in Relapsed/Refractory Multiple Myeloma
On Semptember 3rd AbbVie announced positive topline results from the global Phase 3 CERVINO study evaluating etentamig, an investigational BCMA × CD3 bispecific T-cell engager, in patients with triple-class exposed relapsed or refractory multiple myeloma. Etentamig was compared with the investigator’s choice of standard available therapies.
The randomized, open-label study enrolled 393 patients who had received a median of three prior lines of therapy. At a median follow-up of 11.4 months, the trial met its dual primary endpoints of objective response rate and progression-free survival.
The objective response rate was 74.0% with etentamig, compared with 45.7% with standard available therapies. Etentamig also reduced the risk of disease progression or death by 60%, with a progression-free survival hazard ratio of 0.40. The PFS benefit was reported across all prespecified subgroups evaluated.
At 12 months, overall survival was 87.9% in the etentamig arm and 72.0% in the comparator arm. However, the prespecified efficacy boundary for overall survival had not been crossed at the data cutoff.
Etentamig was administered once every four weeks following a single step-up dose. Grade 3 or 4 infections occurred in 27.7% of patients receiving etentamig and 19.2% of those receiving standard therapies, while grade 5 infections were reported in 1.5% and 3.1% of patients, respectively. Cytokine release syndrome occurred in 28.3% of patients receiving the single step-up dose and was predominantly grade 1, with no grade 3 or higher events reported. One grade 1 case of immune effector cell-associated neurotoxicity syndrome was observed. Treatment discontinuations due to treatment-emergent adverse events occurred in 3.6% of the etentamig arm and 9.6% of the comparator arm.
This was the first planned efficacy interim analysis. Based on the observed benefit, the Independent Data Monitoring Committee recommended unblinding the study. AbbVie stated that it plans to discuss the findings with global regulatory authorities to determine the next steps for etentamig.
CERVINO (NCT06158841) is a global, Phase 3, multicenter, randomized, open-label study evaluating etentamig versus investigator's choice of standard available therapies (SAT) in patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy, including exposure to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody. Patients were randomized 1:1 to receive etentamig administered once every four weeks (Q4W) or SAT, including carfilzomib plus dexamethasone, elotuzumab plus pomalidomide and dexamethasone, or selinexor plus bortezomib and dexamethasone. Etentamig was administered using an optimized dosing strategy that incorporates a single step-up dose followed by monthly (Q4W) dosing from initiation. The dual primary endpoints of CERVINO are overall response rate (ORR) and progression-free survival (PFS). Key secondary endpoints include overall survival (OS), depth of response, measurable residual disease (MRD) negativity, disease symptoms and physical
Press release available at this link
Grazie per il tuo feedback!