Johnson & Johnson’s (J&J’s) multiple myeloma combination of Tecvayli (teclistamab-cqyv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) as an induction treatment has elicited a 100% overall response (OR) in transplant-eligible, newly diagnosed patients.
Updated results from the Phase II MajesTEC-5 trial (NCT05695508) show that 100% of patients achieved OR after treatment with the combination therapy. Of the 46 minimal residual disease (MRD)-evaluable patients, 100% achieved MRD negativity by next-generation flow at 10-5 sensitivity threshold after cycle six.
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Overall, 85.7% of patients achieved a complete response or better (≥CR) and were MRD-negative at cycle six, and 96% of patients successfully completed stem cell mobilisation with a median total stem cell yield of 8.1×106/kg.
In total, 49 patients were treated across three treatment cohorts, with a steroid-sparing approach, including regimens of Tecvayli with Darzalex Faspro and lenalidomide, with and without bortezomib.
Dr Marc Raab, of Heidelberg University Hospital, Germany, said: “Multiple myeloma weakens the immune system over time, making it difficult to eliminate cancerous plasma cells. It’s critical to treat patients with the most effective regimens in the newly diagnosed setting. Tecvayli and Darzalex Fasprowork synergistically to significantly reduce cancer cells – resulting in deep responses with potential for long-term benefit.”
The most common treatment-emergent adverse events (TEAEs) were Grade 3 or 4 haematologic infections, which occurred in 36.7% of patients. While serious TEAEs occurred in 53% of patients, no TEAEs led to full study treatment discontinuation, and no Grade 5 adverse events were observed.
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By GlobalDataTecvayliwas approved by the US Food and Drug Administration (FDA) in October 2022 for use in patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody (mAb).
Darzalex Faspro was approved earlier, in May 2020, for use in newly diagnosed or relapsed/refractory multiple myeloma.
Multiple myeloma market set for growth
Each year, over 35,000 new cases of multiple myeloma are diagnosed in the US, and nearly 13,000 patients die from the disease.
Currently, initial treatment for multiple myeloma includes Velcade (bortezomib), Revlimid (lenalidomide), and Darzalex. In cases of relapse, Kyprolis (carfilzomib) and Pomalyst (pomalidomide) are used.
GlobalData analysis predicts the multiple myeloma market is expected to grow to $29bn in 2032, with the US to remain the dominant region across the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China).
GlobalData is the parent company of Clinical Trials Arena.
