Johnson & Johnson (NYSE:JNJ) on Friday announced that an investigational immune-based induction regimen with Tecvayli (teclistamab) and Darzalex Faspro (daratumumab and hyaluronidase) demonstrated meaningful clinical efficacy in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM).
Forty-nine 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.
Overall response (≥partial response) was achieved by 100% of patients in all treatment arms following induction therapy.
Of 46 minimal residual disease (MRD)-evaluable patients with available samples after Cycle 3 and/or Cycle 6, 100% achieved MRD negativity by next-generation flow at 10-5 sensitivity threshold.
By next-generation sequencing, all were MRD-negative at 10-6 after Cycle 6.
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Overall, 85.7% (42/49) of patients achieved a complete response or better (≥CR) and were MRD-negative at Cycle 6.
Additionally, 96% of patients completed stem cell mobilization with a median total stem cell yield of 8.1×106/kg.
The most common treatment-emergent adverse events (TEAEs) were hematologic, and Grade 3/4 infections occurred in 36.7% of patients. Serious TEAEs occurred in 53% (n=26) of patients.
No TEAEs led to complete study treatment discontinuation, and no Grade 5 adverse events were observed.
On Friday, the Committee for Medicinal Products for Human Use (CHMP) recommended approving Imaavy (nipocalimab) for generalized myasthenia gravis.
In clinical trials, the benefits of Imaavy plus standard of care include reduced functional disability as rated by patients, and decreased disease severity as assessed by qualified physicians, compared with placebo plus standard of care.
Price Action: JNJ stock is up 1.30% at $176.43 at the last check on Friday.
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