USA—Johnson & Johnson (J&J) and its partner Legend have taken a significant step towards expanding the use of their cancer cell therapy, Carvykti, following a major clinical trial victory.
The company recently presented detailed findings revealing that Carvykti demonstrated substantial superiority over the current standard treatment for multiple myeloma.
In the trial, Carvykti demonstrated a remarkable 74% reduction in the risk of disease progression or death compared to one of the commonly used drug combinations.
This represents the largest relative risk reduction reported in a Phase 3 study for the treatment of this blood cancer.
While fragments of the data were leaked in April, the complete results were unveiled at the American Society of Clinical Oncology’s annual meeting.
The comprehensive data reaffirms Carvykti’s potential to be used as an option after the failure of Revlimid, a mainstay medicine for multiple myeloma.
This suggests that Carvykti can be utilized earlier in the treatment phase, rather than being reserved for patients who have undergone multiple prior treatments.
J&J intends to leverage this data to seek expanded approval, which would significantly broaden the market for this cellular therapy.
The study, known as CARTITUDE-4, enrolled 419 patients with multiple myeloma who no longer responded to Revlimid.
Half of the participants received Carvykti after interim treatment with a combination of multiple myeloma therapies, while the other half received one of two three-drug regimens.
The overall response rate was striking, with 84% of patients assigned to receive Carvykti experiencing a reduction in their blood cancer counts, compared to 67% in the standard treatment group.
Notably, only 32 individuals were unable to receive Carvykti due to disease progression or death. Among the 176 patients who received the treatment, an impressive 99% responded positively.
Despite its efficacy, Carvykti does come with significant side effects, including infections, low blood cell counts, neurological toxicity, and a potentially dangerous immune reaction known as cytokine release syndrome (CRS).
Approximately three-quarters of participants who received Carvykti developed CRS, with only two cases rated as severe.
Carvykti belongs to a class of therapies called CAR-T (chimeric antigen receptor T-cell) therapy.
These personalized treatments are engineered from the immune cells of each patient and designed to target specific proteins on the surface of cancer cells. In the case of Carvykti, the targeted protein is BCMA.
J&J, in collaboration with Legend, obtained U.S. approval for Carvykti in February 2022 for multiple myeloma patients whose cancer had relapsed or become resistant to at least four prior drugs.
If the expanded indication is approved, J&J and Legend will have an opportunity to compete against Bristol-Myers Squibb and 2Seventy bio’s BCMA CAR-T therapy, Abecma, which is currently approved as a fifth-line or later treatment option.
The companies have already filed for the new use in Europe.
Bristol-Myers Squibb has also filed for label expansion for its CAR-T therapy based on the KarMMA-3 study, which focuses on patients who have failed two to four lines of prior therapy.
The FDA is expected to make a decision on this application by the end of the year. This gives J&J and Legend a chance to position their CAR-T therapy one step ahead of their rival.
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