J&J Reports Positive Phase III Results for Carvykti and Darzalex Faspro in Multiple Myeloma Trials

Johnson & Johnson has announced promising results from clinical trials of its key multiple myeloma treatments, Carvykti and Darzalex Faspro. These findings could significantly enhance the company's growth prospects.

Johnson & Johnson revealed that its multiple myeloma drug Carvykti is associated with a 45% reduction in the risk of death in patients, while Darzalex Faspro is linked to a 61% improvement in minimal residual disease-negativity. This positive data was revealed at the 2024 International Myeloma Society (IMS) Annual Meeting.

The company's multiple myeloma franchise has been a crucial revenue generator. In the second quarter, sales of Darzalex, an anti-CD38 antibody, rose by 21.3%, a growth primarily driven by increased market share. Meanwhile, revenue from Carvykti, a newer BCMA-directed CAR-T cell therapy, skyrocketed by 59.9%, reaching $186 million over the same period.

The Carvykti study presented at the IMS meeting included three-year data from a Phase III trial evaluating the therapy as a second-line treatment. The trial compared Carvykti to standard therapies such as pomalidomide, bortezomib, and dexamethasone (PVd), or daratumumab, pomalidomide, and dexamethasone (DPd). After three years, Carvykti showed a 45% reduction in the risk of death compared to standard treatments. Specifically, the overall survival rate after 30 months was 76% for Carvykti patients, compared to 64% for those on PVd or DPd. Furthermore, the Carvykti group has not yet reached median progression-free survival, whereas standard therapies have a median progression-free survival of nearly 11.8 months.

Analysts from BMO Capital Markets noted that Carvykti's strong and durable efficacy, characterized by statistically significant overall survival benefit, will likely continue to drive its uptake and serve as a competitive advantage. They also foresee this data helping Johnson & Johnson potentially grow Carvykti sales to $10 billion, particularly given the lack of an overall survival benefit in Bristol Myers Squibb’s competing therapy, Abecma.

However, William Blair analysts described the data as 'incrementally positive' and emphasized that the availability of commercial manufacturing slots would be a primary revenue driver in the short term.

Darzalex Faspro, another significant product for Johnson & Johnson, is already generating $10 billion annually. At the IMS meeting, the company presented Phase III data on Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma patients. The data indicated a 60.9% improvement in minimal residual disease-negativity, meeting the study's primary endpoint. Additionally, the drug showed a 43% reduction in the risk of disease progression or death.

This announcement comes on the heels of Sanofi's recent FDA approval for its CD38 drug Sarclisa, also in combination with VRd, for the same patient population. While Sarclisa has a 40% reduction in the risk of disease progression or death from its clinical trial, it has yet to achieve blockbuster sales, generating less than $500 million last year. Nonetheless, Sarclisa has a first-mover advantage in its indication.

Johnson & Johnson's recent clinical trial data for Carvykti and Darzalex Faspro positions the company favorably in the competitive landscape of multiple myeloma treatments, potentially driving significant future growth.