Johnson & Johnson (J&J) has posted a duo of Phase III wins for two of its budding multiple myeloma combination therapies – potentially seeing one of its approved fifth-line medicines enter the treatment paradigm as early as second-line.
In the Phase III MonumenTAL-6 study (NCT06208150), J&J pitted a combination of its BCMA-targeting therapy, Tecvayli (teclistamab) and GPRC5D-directed drug, Talvey (talquetamab), as well as Talvey plus pomalidomide, against investigator’s choice therapeutic combinations in patients with relapsed or refractory multiple myeloma.
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Following treatment, patients who received either investigational combination experienced a statistically significant improvement in progression-free survival (PFS) over the investigator’s choice arm, with the risk of progression or death in the Tecvayli-Talvey and Talvey-pomalidomide arms dropping by 89% and 73%, respectively.
Both combinations also offered significant improvements to overall survival (OS). Of the two regimens J&J tested, Tecvayli-Talvey offered the most benefit, as treated patients experienced a 62% reduction in the risk of death.
On top of the promising efficacy of these combination approaches, J&J says each duo’s safety profile closely mimics that of the monotherapies – though the company is yet to debut any safety data from the MonumenTAL-6 trial specifically.
According to Ajay Nooka, director of the Myeloma Program at Emory University School of Medicine, the MonumenTAL-6 findings add to a “growing body” of Phase III evidence behind the early use of immunotherapy doublets in the treatment approach due to their capacity to prompt “deep and durable responses … to improve outcomes for patients across practice settings”.
Talvey and Tecvayli have also shown their strong therapeutic potential in earlier disease lines in other studies presented at the 2026 European Hematology Association (EHA) conference.
Multiple myeloma market competition stiffens
This positive Phase III readout will be welcome news for J&J, which is currently looking to bolster its standing in the multiple myeloma field currently dominated by Bristol Myers Squibb (BMS). With results in hand, J&J plans to head to regulators, which could see Tecvayli-Talvey and Talvey-pomalidomide secure a place in earlier treatment lines within multiple myeloma.
Currently, US regulators have only approved Talvey in the fifth line-plus setting, meaning its move up the treatment paradigm to second line could have significant implications for the drug’s potential uptake on the market. Tecvayli is currently approved in the US alongside Darzalex Faspro (daratumumab, hyaluronidase-fihj) in the second-line setting, and as a monotherapy in the fifth line.
Previously, GlobalData analysts noted that bispecific T-cell engagers (BiTEs) like Tecvayli and Talvey would disrupt the relapsed/refractory multiple myeloma market, though clinicians treating patients with such therapies must contend with the drug class’s link to cytokine release syndrome (CRS), anaemia, and low neutrophil levels.
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Next-generation CAR-T approaches are also generating buzz in the multiple myeloma space, with therapies like Gilead-owned Kite Pharma’s anitocabtagene-autoleucel, which aims to improve on its drug class predecessors by enhancing binding capacity and increasing cytotoxicity to the tumour, garnering analyst attention.
As CAR-Ts become a mainstay treatment option within the multiple myeloma treatment paradigm, several companies are also exploring the potential of the in vivo cell therapy approach, with early studies such as Kelonia Therapeutics’ Phase I inMMyCAR trial yielding positive results.
