Johnson & Johnson (J&J) has reported positive second interim analysis data from the Phase III CARTITUDE-4 clinical trial of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for relapsed or lenalidomide-refractory multiple myeloma following one prior therapy line.

The randomised study is designed to assess the efficacy and safety of CARVYKTI against standard-of-care treatments, including pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).

Adults with relapsed and lenalidomide-refractory multiple myeloma who have received one to three therapy lines previously are part of the trial.

Progression-free survival (PFS) is the primary endpoint of the CARTITUDE-4 study while overall survival (OS), minimal residual disease negative rate, and overall response rate are the secondary endpoints.

The interim analysis data revealed that patients treated with CARVYKTI experienced a statistically significant and clinically meaningful improvement in OS versus those receiving standard therapies.

In addition, the safety data from this study were consistent with the therapy’s approved label.

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CARVYKTI obtained approval from the US Food and Drug Administration in February 2022 to treat adults with relapsed or refractory multiple myeloma following four or more prior therapy lines.

In April this year, the indication was expanded to include adults with relapsed or refractory multiple myeloma who have received at least one prior therapy line, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide.

Johnson & Johnson Innovative Medicine Multiple Myeloma Disease area leader and vice-president Jordan Schecter said: “CARVYKTI, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line.

“As we continue to strive to change outcomes and advance care for every person living with multiple myeloma, we’re excited to share these results, which add to the growing body of evidence across our portfolio of differentiated, complementary therapies that attack the disease in different ways throughout the course of a patient’s journey.”

Last month, the company announced findings from the Phase II DAHLIAS dose-ranging study, where its monoclonal antibody nipocalimab offered significant improvements in SjD activity in patients.

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