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TORONTO - Johnson & Johnson (NYSE:JNJ) announced Friday that its investigational immune-based induction regimen combining TECVAYLI and DARZALEX FASPRO demonstrated significant efficacy in transplant-eligible patients with newly diagnosed multiple myeloma.
According to updated results from the Phase 2 MajesTEC-5 study, 100% of evaluable patients achieved minimal residual disease (MRD) negativity following induction therapy. The study evaluated 49 patients across three treatment cohorts using a steroid-sparing approach.
All patients achieved overall response following induction therapy, with 85.7% reaching complete response or better while being MRD-negative at Cycle 6. Additionally, 96% of patients successfully completed stem cell mobilization with a median total stem cell yield of 8.1x106/kg.
The safety analysis showed that while 65% of patients experienced cytokine release syndrome, all cases were Grade 1/2. The most common treatment-emergent adverse events were hematologic, with Grade 3/4 infections occurring in 36.7% of patients. No treatment-emergent adverse events led to full study discontinuation, and no Grade 5 adverse events were observed.
"Multiple myeloma weakens the immune system over time, making it difficult to eliminate cancerous plasma cells," said Marc S. Raab, M.D., of Heidelberg University Hospital, Germany, in the press release.
The MajesTEC-5 clinical trial is an ongoing Phase 2 study evaluating combination regimens including teclistamab and daratumumab in newly diagnosed transplant-eligible multiple myeloma patients. The study is sponsored by the German-Speaking Myeloma Multicenter Group and Deutsche Studiengruppe Multiples Myelom, conducted in collaboration with Johnson & Johnson.
Multiple myeloma is an incurable blood cancer affecting plasma cells in the bone marrow. It is the third most common blood cancer worldwide, with an estimated 35,000 new diagnoses and over 12,000 deaths expected in the U.S. in 2024.
This information is based on a company press release statement.
In other recent news, Johnson & Johnson has announced several significant developments. The company received FDA approval for Inlexzo, a pioneering intravesical drug-releasing system designed for extended local delivery into the bladder, targeting adult patients with BCG-unresponsive non-muscle invasive bladder cancer. This approval marks a notable advancement in cancer treatment options. Additionally, Goldman Sachs has raised its price target for Johnson & Johnson to $186.00, maintaining a Conviction Buy rating, citing confidence in new pharmaceutical product cycles, particularly the newly approved Inlexzo.
Furthermore, Johnson & Johnson reported that its experimental oral psoriasis drug, icotrokinra, outperformed deucravacitinib in Phase 3 clinical trials, achieving superior skin clearance while maintaining similar adverse event rates to a placebo. Guggenheim, however, maintained a Neutral rating on the company with a $167.00 price target, noting the FDA approval of Inlexzo as a validation of their conviction in the asset. In corporate governance news, Johnson & Johnson appointed John Morikis, former CEO of The Sherwin-Williams Company, to its Board of Directors, bringing his extensive leadership experience to the company. These developments reflect Johnson & Johnson’s ongoing efforts in advancing its pharmaceutical and leadership strategies.
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