Peter Voorhees, MD, Atrium Health and Levine Cancer Institute, Wake Forest University School of Medicine, discusses results from the CARTITUDE-1 study in patients with multiple myeloma (MM).
MM is a bone marrow-based plasma cell neoplasm characterized by a serum monoclonal protein and skeletal destruction. Common symptoms include osteolytic lesions, pathological fractures, bone pain, hypercalcemia, and anemia. The exact underlying cause of multiple myeloma is currently unknown.
Cilta-cel is a B-cell maturation antigen-directed genetically modified autologous T cell immunotherapy. The CARTITUDE-1 clinical trial was a phase 1b/2, open-label study evaluating cilta-cel in patients with relapsed/refractory MM who had been heavily pretreated. A total of 97 patients received a single infusion of cilta-cel.
CARTITUDE-1 Study Results
Of the 97 patients treated, 32 remain alive and progression free after five years or more of receiving cilta-cel, without further treatment. Of these 32 patients, the median time from the start of their previous line of therapy to disease progression prior to trial enrollment was 4.0 months. Those who remained progression-free for 5 or more years, despite having high-risk cytogenetics or extramedullary disease, shared baseline characteristics comparable to those who experienced progression within 5 years.
Several biomarkers significantly correlated with ≥5-year progression-free status. These included a higher proportion of naïve T cells in the infused CAR-T product, a lower neutrophil-to-T cell ratio, elevated baseline hemoglobin and platelet levels, and a higher effector-to-target ratio (measured by peak CAR-T concentration to baseline sBCMA levels). At peak concentration, long-term responders also had significantly higher levels of CD4 central memory CAR+ T cells and CAR+ T cells expressing activation markers CD38, CD25, and PD-1.
At one single center, all 12 patients who were progression-free for ≥5 years were consistently MRD-negative at 10⁻⁶ and PET/CT-negative annually for 5 years.
Overall, at a median follow-up of 60.3 months in the full CARTITUDE-1 cohort (N=97), median overall survival was 60.6 months (95% CI, 41.9–not estimable). Three additional cases of second primary malignancies were reported, including one case of acute myeloid leukemia. No new instances of movement or neurocognitive disorders were observed. The median overall survival was 5 years and 33% of patients remain progression free for 5 or more years following a single cilta-cel infusion
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