Tecvayli Plus Darzalex Shows Strong Results in Newly Diagnosed Myeloma

An investigational immune-based induction regimen with Tecvayli (teclistamab-cqyv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) demonstrated meaningful clinical efficacy in transplant-eligible patients with newly diagnosed multiple myeloma, according to a news release from Johnson & Johnson.

"Multiple myeloma weakens the immune system over time, making it difficult to eliminate cancerous plasma cells," Dr. Marc S. Raab, Heidelberg University Hospital, Germany, said in the news release. "It's critical to treat patients with the most effective regimens in the newly diagnosed setting. Tecvayli and Darzalex Faspro work synergistically to significantly reduce cancer cells — resulting in deep responses with potential for long term benefit."

In this study, a total of 49 patients were treated across three groups with a steroid-sparing approach that included combinations of Tecvayli with Darzalex Faspro and lenalidomide, with and without bortezomib. Every patient across all treatment groups responded to induction therapy, with at least a partial response. Among the 46 patients who could be evaluated for measurable residual disease (MRD) after cycle 3 and/or cycle 6, all were found to have no detectable cancer cells when very sensitive tests were used.

One of these tests, called next-generation flow, can find as few as one cancer cell among 100,000 healthy cells, and another test, next-generation sequencing, can find as few as one cancer cell among 1,000,000 healthy cells. In total, 85.7% (42 of 49) achieved a complete response or better and were MRD-negative at cycle 6 at the one in 100,000 level. Nearly all patients (96%) successfully completed stem cell mobilization, with a median total stem cell yield of 8.1 million cells per kilogram.

"Exploring Tecvayli, with its established use in later lines of treatment, and Darzalex Faspro, a foundational therapy across all lines, together helps us understand how this doublet immunotherapy can support patients across different stages of disease," Dr. Jordan Schecter, vice president, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, said in the news release.

What are the Side Effects of Tecvayli and Darzalex Faspro?

The most common treatment-emergent side effects were hematologic, and grade 3 (severe) or 4 (life-threatening) infections occurred in 36.7% of patients. Serious side effects occurred in 53% (26 patients). No side effects led to full study treatment discontinuation and no grade 5 (death) side effects were observed. Additionally, no patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). Cytokine release syndrome (CRS) was observed in 65% of patients (32 patients) and all were grade 1 (mild) or 2 (moderate).

"Importantly, immune-based therapies like Tecvayli have the potential to improve patient outcomes with a manageable safety profile, particularly when used earlier in the treatment journey, with 100 percent of evaluable patients achieving MRD negativity,” Schecter continued. “We continue to explore Tecvayli in earlier lines of therapy and across difficult-to-treat populations."

About the MajesTEC-5 Study

The MajesTEC-5 study is an ongoing phase 2 clinical trial looking at the safety and effectiveness of treatment combinations that include Tecvayli and Darzalex in people who are newly diagnosed with multiple myeloma and are eligible for a stem cell transplant. The trial is sponsored by the German-Speaking Myeloma Multicenter Group and the German Multiple Myeloma Study Group, and it is being conducted in collaboration with Johnson & Johnson.

About Tecvayli

Tecvayli received approval from the U.S. Food and Drug Administration in October 2022. It is an “off-the-shelf,” or ready-to-use, antibody given as an injection under the skin for adults with relapsed or refractory multiple myeloma who have already received at least four previous treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. Since its approval, more than 15,900 people around the world have been treated with Tecvayli.

Reference

1. “TECVAYLI® and DARZALEX FASPRO®-based induction treatment demonstrates promising rates and depths of response in transplant-eligible patients with newly diagnosed multiple myeloma.” Johnson & Johnson. News Release. Sep 23, 2025.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.