With nearly 90% of patients showing no detectable cancer cells after treatment, J&J and Legend’s Carvykti could stave off competition from emerging CAR T therapies such as Gilead and Arcellx’s anito-cel.
Johnson & Johnson and Legend Biotech on Tuesday unveiled new data from the Phase III CARTITUDE-4 trial demonstrating that their CAR T therapy Carvykti (ciltacabtagene autoleucel) achieves a high rate of disease clearance in patients with relapsed or refractory multiple myeloma.
After almost three years of median follow-up, 89% of evaluable patients achieved minimal residual disease (MRD) negativity, meaning that they had no detectable cancer cells after Carvykti treatment.
At this time point, Carvykti’s MRD negativity rate is “more than double” than that in patients treated with standard therapies, a treatment effect that was highly statistically significant with a p-value less than 0.0001, according to Tuesday’s announcement.
Results were even better at an earlier follow-up—at a median of 30 months—at which point 52% of Carvykti-treated patients had achieved MRD negativity, as compared with 10% of those on standard regimens.
As for safety, CARTITUDE-4 showed that 97% of patients in both study arms experienced grade 3 or 4 treatment-emergent adverse events. In the Carvykti group, seven developed hematologic second primary malignancies, while 50 died. Progressive disease accounted for 21 of the deaths.
Tuesday’s readout follows an earlier data drop in September, which showed that Carvykti led to a significant increase in overall survival and cut the risk of death by 45% versus standard therapies. At the time, J&J and Legend claimed that Carvykti was the “first cell therapy to significantly extend overall survival versus standard therapies” in this indication.
Taken together, MRD negativity and survival data point to the potential of Carvykti to “redefine the treatment landscape for patients diagnosed with this complex disease,” Edmon Chan, EMEA Therapeutic Area Lead for Hematology at J&J Innovative Medicines, said in a statement.
William Blair analysts were likewise optimistic about Carvykti, though to a more measured degree. In a Tuesday note, the analysts called J&J and Legend’s data “robust” and said it will “further support the use of Carvykti in the second-line setting.”
Still, William Blair thinks that Tuesday’s data on MRD will ultimately only be “incrementally positive” for the partners—specifically for Legend—especially as investors become increasingly focused on “the impact that emerging BCMA CAR-Ts could have on Carvkyti’s peak market share and revenue.”
One of these upcoming CAR T challengers is Gilead’s and Arcellx’s anitocabtagene autoleucel, which on Sunday showed efficacy results that were competitive to Carvykti, coupled with a superior safety profile that could help the investigational therapy carve its own niche in the market.
In particular, Gilead and Arcellx highlighted that anito-cel had no delayed neurotoxicities, such as cranial nerve palsies or Parkinsonism. In a Monday note, BMO Capital Markets analysts said that safety “is a key focus for commercialization” for anito-cel, which could allow it to “overcome Carvkyti’s lead” in relapsed or refractory multiple myeloma. Gilead and Arcellx hope to launch anito-cel by 2026.
