Leaked data shows stellar efficacy for J&J’s Carvykti

Johnson & Johnson was preparing to divulge the data from its eagerly-awaited CARTITUDE-4 trial of CAR-T therapy Carvykti later this year, but a leak of the data has given an early glimpse of what look like outstanding results.

J&J and partner Legend Biotech had already revealed that the study had hit its main objective, but the European Haematology Association (EHA) abstract drop reveals that Carvykti (ciltacabtagene autoleucel) reduced the risk of progression or death by an impressive 74% versus standard therapy in patients with multiple myeloma.

The leak was first reported by Stat, and J&J has indicated that it cannot confirm the numbers as it is sticking to an embargo agreed with the American Society of Clinical Oncology (ASCO), as the data was scheduled for presentation at its annual congress in June. The EHA meeting will take place later the same month.

CARTITUDE-4 was unblinded early because the results were strong, said J&J back in January, and the result could dramatically increase uptake of the therapy, which has so far been approved as a fifth-line or later therapy for multiple myeloma.

The study tested Carvykti in patients with second- to fourth-line multiple myeloma, and the data gives J&J and Legend an opportunity to steal a march on Bristol-Myers Squibb and 2Seventy bio’s rival BCMA CAR-T therapy Abecma (idecabtagene vicleucel), also currently approved as a fifth-line or later option.

Carvykti also achieved a sizeable improvement on the objective response rate (ORR) endpoint compared to standard care, at 88% versus 67%, including 73% and 22% complete responses, respectively.

At 12 months, progression-free survival rate was 76% with Carvykti versus 49% for the control group and, while the overall survival (OS) data is not yet mature, there is a trend in favour of the CAR-T that, at the data cut-off point, suggests a 22% reduction in death.

For comparison, Abecma achieved a 51% reduction in disease progression or death in the KarMMA-3 study, although that was in a sicker population, making a direct comparison challenging.

The source of the leak on Tuesday evening has not been discovered as yet, and is likely to be keenly scrutinised, given the impact on Legend’s share price, which leaped around 18% to nearly $62 at the news. J&J’s stock also ticked up fractionally, although the news emerged around the same time as its first-quarter results update, which saw it swing to a loss on litigation charges.

Sales of Carvykti have grown slowly since it was first approved, and J&J reported that it made $72 million in the first quarter of this year, up from $55 million in the fourth quarter of 2002, when Abecma brought in $125 million.

BMS has already filed to expand the label for its CAR-T, with a decision due from the FDA before the end of the year.