Myeloma treatment combo sees 100% response rate in trial
Tecvayli-Darzalex Faspro shows promise in newly diagnosed patients
Combination treatment with Tecvayli (teclistamab-cqyv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) led to a 100% response rate for 49 people with newly diagnosed multiple myeloma, according to new data announced by Johnson & Johnson.
The data come from the Phase 2 trial MajesTEC-5 (NCT05695508), which is testing combinations of Tecvayli and Darzalex Faspro in people with newly diagnosed myeloma. The trial, sponsored by the University of Heidelberg Medical Center, is being run at 11 sites in Germany.
Tecvayli and Darzalex Faspro are subcutaneous (under-the-skin) injection therapies sold by Johnson & Johnson. Tecvayli is approved to treat certain hard-to-treat myeloma patients, while Darzalex Faspro is indicated in various combinations for newly diagnosed or previously treated myeloma patients. Both therapies contain antibodies designed to trigger the immune system to attack myeloma cells.
“Multiple myeloma weakens the immune system over time, making it difficult to eliminate cancerous plasma cells,” Marc Raab, MD, professor of medicine at Heidelberg University Hospital, said in a press release from Johnson & Johnson. “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.”
Looking at Tecvayli’s potential
The 49 patients were treated with Tecvayli and Darzalex Faspro in addition to Revlimid (lenalidomide). Some also received Velcade (bortezomib). According to Johnson & Johnson, all 49 responded to the treatment, meaning their cancer burden decreased.
Nearly all patients were minimal residual disease negative (MRD), meaning they had no detectable cancer cells. After six treatment cycles, 42 of the 49 patients (about 86%) had a complete response or better and were MRD negative. Nearly all patients (96%) were also able to successfully complete stem cell mobilization, a process that moves stem cells from the bone marrow into the bloodstream so they can be collected for a future transplant.
“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,” said Jordan Schecter, MD, vice president and disease area leader for multiple myeloma at Johnson & Johnson Innovative Medicine.
Safety data showed the most common side effects were blood-related. Cytokine release syndrome, an inflammatory reaction that can occur with immune-based cancer therapies, was seen in about two-thirds of patients. Just over half experienced serious side effects, but no fatal reactions were reported.
“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,” Schecter said. “We continue to explore Tecvayli in earlier lines of therapy and across difficult-to-treat populations.”
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