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Jesus Berdeja, MD, discusses updated results from the ongoing phase 1b/2 CARTITUDE-1 trial (NCT03548207) in multiple myeloma.
Jesus Berdeja, MD, the director of Multiple Myeloma Research at Sarah Cannon Research Institute, discusses updated results from the ongoing phase 1b/2 CARTITUDE-1 trial (NCT03548207) in multiple myeloma.
Twenty-nine patients were enrolled in the phase 1b portion of the trial, says Berdeja. Eligibility criteria for CARTITUDE-1 included measurable and progressive disease; an ECOG performance status of less than 1; at least 3 prior therapies or double-refractory status; and prior treatment with a proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy. Patients were heavily pretreated, having received a median of 5 prior lines of therapy. Additionally, 86% of patients were triple refractory, says Berdeja.
According to updated results, the overall response rate was 100%, with a stringent complete response rate of 86% (25 out of 29 patients). The estimated progression-free survival at 9 months was 86%. Additionally, no unexpected safety signals were reported, says Berdeja. The majority of patients experienced grade 1/2 cytokine release syndrome (CRS) with a median time to onset of 7 days. Neurotoxicity was rare, says Berdeja. All-grade neurotoxicity was observed in 10% of patients, with 3% of patients having grade 3 or higher toxicity. The most frequent adverse events were neutropenia (100%), CRS (93%), and thrombocytopenia (86%). However, most cytopenias resolved within 60 days, says Berdeja.
At a median follow-up of 11.5 months, 22 of 29 patients were alive and progression-free. Additionally, of the 16 patients with a complete response who were evaluable for minimal residual disease (MRD) assessment, 81% and 69% were MRD negative at sensitivities of 10-5 and 10-6, respectively.