ASCO 2017 - Relapsed/refractory multiple myeloma: LCAR-B38M yields 100% ORR in phase 1 trial

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Takeaway

  • At a maximum tolerated dose of 5mm/kg cells, interim results in this phase 1 trial of the immunotherapeutic agent LCAR-B38M (Legend Biotech) CAR-T targeting B cell maturation antigen in multiple myeloma include 100% ORR, with 18 pts reaching CR or near CR status.

Why this matters

  • Multiple myeloma currently incurable.
  • Chimeric Antigen Receptor engineered T cell (CAR-T) has been effective targeting the B-cell biomarker CD19 in acute lymphblastic leukemia.  
  • Trial to be expanded to ~100 patients.

Study design

  • Single arm interventional trial in China to assess safety and efficacy of LCAR-B38M CAR-T cell therapy in patients with relapsed/refractory multiple myeloma.
  • Investigational drug targets antigen which plays a role in disease progression.
  • T cells harvested and "reprogrammed" with an artificially designed gene which seeks and destroys cancer cells.
  • Funding: Legend Biotech, Nanjing, China

Key results

  • (N=100 estimated total enrollment); interim results on first 35 patients. 
  • Objective Response Rate (ORR) 100%; 33/35 had evident clinical remission (CR), very good partial response (VGPR), or PR within 2 months. 
  • 19/3...