A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs.

The cancer cell therapy Carvykti dramatically outperformed standard drugs in a late-stage clinical trial testing its use in earlier treatment of the blood cancer multiple myeloma, according to data from a study abstract that was briefly posted online Tuesday.

The abstract showed Carvykti, which is made by Johnson & Johnson and Legend Biotech, reduced the risk of disease progression or death by 74% compared to standard of care — a degree of benefit that analysts who viewed it described as “stellar” and “highly encouraging.”

J&J and Legend had previously said in late January that the study met its main goal, but did not disclose any specific data at the time. The abstract, which is no longer available online, was for presentation at the European Hematology Association’s annual meeting in early June.

In an email, a spokesperson for J&J said the company could not confirm the data due to the embargo rules of the medical meeting where they will be presented. Stat News first reported news of the leaked data.

Carvykti is what’s known as a CAR-T therapy, made from each patient’s immune cells, which are extracted and genetically reengineered to target proteins found on the surface of cancers. It’s currently approved in the U.S. for use treating multiple myeloma patients who have received at least four prior drugs. J&J and Legend aim to expand its approval into earlier “lines” of treatment and the study that the abstract details tested it among patients who had one to three prior therapies.

Called CARTITUDE-4, the trial enrolled just over 400 patients, randomized them to receive either Carvykti or one of two cocktails of standard multiple myeloma drugs. According to analysts, the abstract showed data through a cut-off of Nov. 1, 2022, or a median of 16 months of follow-up post treatment. Median progression free survival — the study’s main goal — was not yet reached among the group getting Carvykti, compared to 12 months for those on standard of care.

The 74% risk reduction those results represent “solidify Carvykti as the best-in-class cell therapy option for multiple myeloma,” wrote Leonid Timashev, an analyst with RBC Capital Markets, in a client note Wednesday.

Yaron Werber, an analyst at TD Cowen, described the benefit as “game-changing efficacy” that is “highly encouraging for adoption” in the second-line treatment setting.

In the U.S., Carvykti competes with another CAR-T therapy called Abecma, made by Bristol Myers Squibb. The therapy, which targets the same BCMA protein as Carvykti, reduced the risk of disease progression and death by 51% in a generally similar trial, results of which were published earlier this year. (The two studies have some differences in design that make an apples-to-apples comparison more difficult.)

Bristol Myers’ application to expand Abecma’s approval is currently under review by the Food and Drug Administration, with a decision expected by December.

Both Bristol Myers and J&J have run into difficulties manufacturing their respective therapies, which as personalized treatments are complex to make and require careful shipping. On Tuesday, J&J disclosed first quarter sales results that were higher than expected, showing Carvykti earned $72 million between January and March.

“The manufacturing is ramping up to supply markets,” said J&J CFO Joe Wolk on an earnings conference call. “We have really tremendous demand given some of the data that supports this Carvykti, the CAR-T for Johnson & Johnson. And we’re committed to doing everything we can to accelerate our manufacturing abilities to meet that demand.”

Last week, J&J and Legend entered into a manufacturing agreement with Novartis, another CAR-T developer, to help produce Carvykti.

Shares in Legend rose by double digits in Wednesday trading on the Nasdaq stock exchange, while J&J’s stock rose less than 1%.

Reference：https://www.biopharmadive.com/news/carvykti-multiple-myeloma-abstract-leaked-johnson-johnson-legend/648030/