Johnson & Johnson’s (J&J’s) two-drug combination has outperformed standard of care (SoC) for relapsed/refractory (R/R) multiple myeloma as early as second-line in a Phase III trial.
During the MajesTEC-3 study (NCT05083169), a combination of J&J’s star subcutaneous oncology assets, Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab and hyaluronidase-fihj) offered significant improvements to progression-free survival (PFS) over SoC.
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Meanwhile, topline overall survival (OS) data found Tecvayli-Darzalex to be superior after a follow-up period of almost three years.
In this Phase III trial, the investigator had the choice of Darzalex Faspro, pomalidomide and dexamethasone (DPd), or Darzalex, bortezomib and dexamethasone (DVd) as SoC. These combinations were evaluated against Tecvayli-Darzalex in patients who had received between one and three prior lines of therapy.
Throughout the late-stage study, the safety profile of Darzalex plus Tecvayli was consistent with that of each treatment as a monotherapy.
While J&J did not disclose the full dataset from this trial, the company noted that it would share the findings at an upcoming medical meeting.
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By GlobalDataDarzalex-Tecvayli shows promise in multiple myeloma
The positive outcome of the Phase III MajesTEC-3 study closely follows the promising results obtained from the Phase II MajesTEC-5 study, which highlighted the combination’s potential as a first-line induction therapy. During the mid-stage trial, Tecvayli-Darzalex demonstrated a 100% overall response rate (ORR) in newly diagnosed, transplant-eligible patients.
Following these two readouts, Yusri Elsayed, Global Therapeutic Area Head of Oncology at J&J Innovative Medicine, noted that Tecvayli and Darzalex Faspro had become two of the company’s most “important agents”.
Elsayed also slated the combination’s potential as a new SoC option for patients in the second-line setting. To get Tecvayli-Darzalex to market, J&J will now share these results with regulatory authorities.
If the US Food and Drug Administration (FDA) gave Tecvayli-Darzalex the go-ahead, it would mark a significant shift in the former drug’s placement in the multiple myeloma treatment paradigm.
Currently, Tecvayli – a B-cell maturation antigen (BCMA)-targeting T-cell engager bispecific – is routinely used in the fourth line and beyond, but its approval alongside Darzalex Faspro could bring it into the second-line treatment paradigm.
This is reflected in a forecast from analysts at GlobalData, who predict that the drug’s sales will hit $4.5bn in 2031 – up more than 700% from the $549m it made for J&J in 2024.
Meanwhile, its partner drug, Darzalex, is one of the company’s best-selling oncology assets this quarter, raking in $3.6bn this quarter alone. A consensus forecast from analysts at GlobalData estimate that the drug will continue to be a big money maker for J&J, reaching peak yearly sales of $16.9bn in 2029 before the drug’s US patent cliff.
Despite the growing success of both Darzalex and Tecvayli, the duo would face stiff competition in the second-line R/R multiple myeloma setting. Key rivals would be Amgen’s Kyprolis (carfilzomib) and GSK’s Blenrep (belantamab), which are routinely used in combination regimens within this setting.
