Johnson & Johnson (J&J; NYSE: JNJ) has released data from a Phase III study showing that its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel), extended the median time until symptom worsening to 23.7 months in patients with relapsed and lenalidomide-refractory multiple myeloma (MM) after one to three prior lines of therapy, compared to 18.9 months with the standard-of-care control. Patient-reported outcomes indicated that one year of treatment with Carvykti led to clinically meaningful improvements in global health status, pain, and the visual analogue scale, but not in fatigue and emotional functioning, which either worsened or showed less improvement in the control group.
Additionally, J&J announced efficacy and safety data from a Phase II trial for the same indication, revealing that after a median follow-up of 29 months, patients with relapsed and refractory MM achieved overall response (OR) rates of 95% and 100%, 24-month progression-free survival (PFS) rates of 75% and 73%, and 24-month overall survival (OS) rates of 75% and 84%, with median PFS not reached.
J&J is developing the Legend Biotech (NASDAQ: LEGN) licensed drug for earlier lines of treatment, following US approval for relapsed or refractory MM after four or more prior lines of therapy and in Europe for relapsed and refractory MM after at least three prior therapies.- Flcube.com
