BCMA-targeting BiTE molecule AMG 420 in relapsed or refractory multiple myeloma: a phase 1b open-label expansion...

Area of Science:

• Oncology
• Immunotherapy

Background:

• Multiple myeloma is a hematologic malignancy with limited treatment options for relapsed/refractory cases.
• Bispecific T-cell engagers (BiTEs) offer a novel approach by redirecting T-cells to target cancer cells.

Purpose of the Study:

• To evaluate the safety, tolerability, and efficacy of AMG 420 monotherapy.
• To establish proof-of-concept for T-cell engager therapy in multiple myeloma.

Main Methods:

• Phase 1b, open-label, dose-expansion study (NCT03836053).
• 23 patients with relapsed/refractory multiple myeloma received AMG 420 intravenously (200-600 µg/day) in 6-week cycles.
• Assessed safety, tolerability, and efficacy.

Main Results:

• Overall response rate was 34.8%.
• Median progression-free survival was 2.83 months.
• 8.7% of patients achieved minimal residual disease-negative complete responses.
• Common adverse events included cytokine release syndrome (CRS), headache, and pyrexia. Two dose-limiting toxicities were reported.

Conclusions:

• AMG 420 demonstrated a proof-of-concept for T-cell engager therapy in multiple myeloma.
• BCMA is an effective target for T-cell engager therapy.
• AMG 420 shows a promising safety profile and efficacy in this patient population.