JNJ: TECVAYLI/DARZALEX FASPRO regimen shows positive results in study

Johnson & Johnson announced that an investigational immune-based induction regimen with TECVAYLI and DARZALEX FASPRO demonstrated meaningful clinical efficacy in transplant-eligible patients with newly diagnosed multiple myeloma. Forty-nine patients were treated across three treatment cohorts, with a steroid-sparing approach, including regimens of TECVAYLI with DARZALEX FASPRO and lenalidomide, with and without bortezomib. Overall response was achieved by 100% of patients in all treatment arms following induction therapy. Of 46 MRD-evaluable patients with available samples after Cycle 3 and/or Cycle 6, 100% achieved MRD negativity by next-generation flow at 10-5 sensitivity threshold. By next-generation sequencing, all were MRD-negative at 10-6 after Cycle 6. Overall, 85.7% (42/49) of patients achieved a complete response or better and were MRD-negative at Cycle 6. Additionally, 96% of patients successfully completed stem cell mobilization with a median total stem cell yield of 8.1×106/kg. Data from the safety analysis reinforced the tolerability of the approach. The most common treatment-emergent adverse events were hematologic, and Grade 3/4 infections occurred in 36.7% of patients. Serious TEAEs occurred in 53% of patients. No TEAEs led to full study treatment discontinuation and no Grade 5 adverse events were observed. Additionally, no patients experienced immune effector cell-associated neurotoxicity syndrome. Cytokine release syndrome was observed in 65% of patients and were all Grade 1/2.