Johnson & Johnson and Legend Biotech's Carvykti (ciltacabtagene autoleucel) has demonstrated a high rate of disease clearance in patients with relapsed or refractory multiple myeloma, according to new data from the Phase III CARTITUDE-4 trial. The study revealed that Carvykti achieved a significantly higher rate of minimal residual disease (MRD) negativity compared to standard therapies.
High MRD Negativity with Carvykti
After a median follow-up of almost three years, 89% of evaluable patients treated with Carvykti achieved MRD negativity, indicating no detectable cancer cells. This MRD negativity rate is more than double that observed in patients treated with standard therapies, a difference that was highly statistically significant (p < 0.0001).
Earlier data, at a median follow-up of 30 months, showed that 52% of Carvykti-treated patients achieved MRD negativity, compared to only 10% in the standard therapy group.
Safety Profile and Adverse Events
The CARTITUDE-4 trial also provided insights into the safety profile of Carvykti. The data showed that 97% of patients in both study arms experienced grade 3 or 4 treatment-emergent adverse events. In the Carvykti group, seven patients developed hematologic second primary malignancies, and 50 deaths were reported, with progressive disease accounting for 21 of these deaths.
Overall Survival Benefit
An earlier data release in September highlighted that Carvykti led to a significant increase in overall survival and reduced the risk of death by 45% compared to standard therapies. Johnson & Johnson and Legend Biotech claimed that Carvykti was the first cell therapy to significantly extend overall survival versus standard therapies in this indication.
Edmon Chan, EMEA Therapeutic Area Lead for Hematology at J&J Innovative Medicines, stated that the combined MRD negativity and survival data indicate Carvykti's potential to "redefine the treatment landscape for patients diagnosed with this complex disease."
Analyst Perspective
William Blair analysts described the data as "robust" and believe it will further support the use of Carvykti in the second-line setting. However, they also noted that the MRD data might only be "incrementally positive" due to increasing investor focus on emerging BCMA CAR-T therapies that could impact Carvykti's market share and revenue.
Emerging Competition
Gilead and Arcellx's anitocabtagene autoleucel is one such emerging CAR T therapy. It has shown efficacy results competitive with Carvykti, coupled with a potentially superior safety profile. Notably, anito-cel had no delayed neurotoxicities, which BMO Capital Markets analysts believe could allow it to overcome Carvykti's lead in relapsed or refractory multiple myeloma. Gilead and Arcellx aim to launch anito-cel by 2026.
