Johnson & Johnson shared encouraging results from an investigational treatment that combines TECVAYLI with DARZALEX FASPRO in patients newly diagnosed with multiple myeloma who are suitable for a stem cell transplant. A total of 49 patients were part of three different treatment groups that used a steroid-sparing method. These groups included combinations of TECVAYLI with DARZALEX FASPRO and lenalidomide, both with and without bortezomib. After the induction phase, every patient in the study had an overall response, which means their disease showed at least a partial reduction. Among the 46 patients evaluated for minimal residual disease (MRD), all reached MRD negativity at a sensitivity level of one in 100,000 cells, as measured by next-generation flow after the third or sixth treatment cycle. When using next-generation sequencing, every patient tested was MRD-negative at an even more sensitive level of one in a million after the sixth cycle. Overall, 85.7 percent of patients achieved a complete response or better along with MRD negativity by the sixth cycle. Additionally, 96 percent of the patients successfully underwent stem cell mobilization, with a median yield of 8.1 million cells per kilogram. Dr. Marc S. Raab from Heidelberg University Hospital in Germany explained that multiple myeloma gradually weakens the immune system, making it hard to eliminate malignant plasma cells. He stressed the importance of treating newly diagnosed patients with highly effective treatments and noted that TECVAYLI and DARZALEX FASPRO work together to significantly reduce cancer cells, potentially offering long-term benefits.

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Safety data shows that the treatment was generally well-tolerated. The most common side effects were related to the blood, while serious infections of grade 3 or 4 occurred in about 37 percent of patients. Over half of the participants experienced serious adverse events, but none stopped treatment due to side effects, and there were no deaths linked to the treatment. There were no cases of immune effector cell-associated neurotoxicity syndrome, and cytokine release syndrome occurred in 65 percent of patients, but it was mild to moderate in severity. Jordan Schecter, Vice President and Disease Area Leader for Multiple Myeloma at Johnson & Johnson Innovative Medicine, pointed out that combining TECVAYLI, which is already used in later treatment stages, with DARZALEX FASPRO, a key therapy across various stages, offers important insights into how these immunotherapies can assist patients throughout their disease journey. He highlighted the 100% MRD negativity rate among patients who were evaluated and emphasized the potential of immune-based therapies like TECVAYLI to enhance patient outcomes with a manageable safety profile when used earlier in treatment. Johnson & Johnson is continuing to explore TECVAYLI in earlier treatment stages and among patients with more challenging disease characteristics.

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The MajesTEC-5 study (NCT05695508) is an ongoing phase 2 clinical trial that is assessing the safety and effectiveness of combinations involving teclistamab and daratumumab in newly diagnosed multiple myeloma patients who are eligible for stem cell transplantation. The trial is supported by the German-Speaking Myeloma Multicenter Group and Deutsche Studiengruppe Multiples Myelom, with collaboration from Johnson & Johnson.

TECVAYLI received U.S. FDA approval in October 2022 as a ready-to-use antibody therapy administered subcutaneously for adults with relapsed or refractory multiple myeloma who have undergone at least four prior treatments, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody. Since its approval, more than 15,900 patients worldwide have been treated with TECVAYLI. In Europe, TECVAYLI was granted conditional marketing authorization in August 2022 for the same patient group. In August 2023, the European Commission approved a reduced dosing schedule for patients who have maintained a complete response for at least six months, allowing administration every two weeks.

TECVAYLI is a bispecific T-cell engager that activates the immune system by binding to the CD3 receptor on T-cells and the B-cell maturation antigen on multiple myeloma cells. The U.S. FDA approved a supplemental application in February 2024 to allow this reduced dosing frequency in appropriate patients.

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