en.Wedoany.com Reported - Data from the MonumenTAL-3 clinical trial show that Tal-DP and Tal-D regimens significantly prolonged progression-free survival (PFS) compared with the DPd regimen in patients with relapsed/refractory multiple myeloma. Results with a median follow-up of 24.6 months indicate that the risk of disease progression or death was reduced by 72% in the Tal-DP group (HR 0.28; 95% CI 0.20–0.40; p<0.0001) and by 67% in the Tal-D group (HR 0.33; 95% CI 0.24–0.46; p<0.0001). The 24-month PFS rates were 81.3% (Tal-DP), 77.6% (Tal-D), and 51.2% (DPd).
This Phase 3 trial, named MonumenTAL-3, enrolled 864 patients who had received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Among the enrolled patients, 85.1% were lenalidomide-refractory, 93.4% were refractory to the last line of therapy, and 11.8% had received prior anti-CD38 therapy. The primary endpoint was PFS, and secondary endpoints included overall response rate (ORR), rate of complete response or better (≥CR), minimal residual disease (MRD) negativity rate with ≥CR, overall survival (OS), and safety. Results showed that ORR was 88.2% in the Tal-DP group and 88.5% in the Tal-D group, compared with 77.6% in the DPd group; ≥CR rates were 71.1%, 68.9%, and 34.5%, respectively; and MRD-negative ≥CR rates (by 10⁻⁵ NGS assay) were 52.3%, 46.3%, and 15.9%, respectively. For OS, the HRs were 0.47 for the Tal-DP group and 0.51 for the Tal-D group, with 24-month OS rates of 89.2%, 87.9%, and 79.1% (DPd group). These results were presented at the EHA 2026 Congress and published in The New England Journal of Medicine.
Safety data showed that the incidence of Grade 3/4 treatment-emergent adverse events (TEAEs) in the Tal-DP, Tal-D, and DPd groups was 94.9%, 74.8%, and 91.5%, respectively. Overall infection rates were 87.3%, 84.3%, and 83.0%, with Grade 3/4 infection rates of 37.7%, 29.2%, and 42.2%, respectively. Grade 5 adverse event (AE) rates were 1.8%, 4%, and 4.6%, respectively. Discontinuation rates due to adverse events were 10.5%, 8.0%, and 6.7%, respectively. Cytokine release syndrome occurred in 67.8% of the Tal-DP group and 58.4% of the Tal-D group, primarily Grade 1–2. Immune effector cell-associated neurotoxicity syndrome was uncommon (2.9% and 1.8%), with no Grade ≥4 events. Dysgeusia, weight loss, and ataxia/balance disorder were mostly low-grade and rarely led to discontinuation.
TALVEY is a bispecific antibody targeting GPRC5D that engages the CD3 receptor on T cells while having minimal activity against normal B cells. Based on data from the MonumenTAL-3 study, Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II variation application to the European Medicines Agency (EMA), seeking approval of TALVEY in combination with DARZALEX FASPRO (with or without pomalidomide) for patients with multiple myeloma who have received at least one prior line of therapy.
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