Johnson & Johnson (J&J) has shared data from several studies evaluating two of its approved therapies in multiple myeloma (MM) at this year’s European Hematology Association (EHA) conference, held in Stockholm, Sweden on June 11–14.
Both Talvey (talquetamab) and Tecvayli (teclistamab-cqyv) are approved to treat relapsed or refractory (R/R) MM, a type of blood cancer.
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As the treatment landscape for R/R MM is rapidly evolving, GlobalData anticipates notable growth in the MM therapeutics market across the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China), according to GlobalData’s Multiple Myeloma: Eight-Market Drug Forecast and Market Analysis 2022–32 report. The market is expected to grow over the forecast period to $29 billion in 2032.
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Talvey combinations push frontline use
New highly anticipated results from the Phase III MonumenTAL-3 trial (NCT05455320) were presented at a session at EHA. In J&J’s study, 864 patients with R/R MM and at least one line of prior therapy were randomised to one of three arms: Talvey plus Darzalex (daratumumab) and pomalidomide (Tal-DP); talquetamab plus daratumumab (Tal-D); or daratumumab, pomalidomide, and dexamethasone (DPd). The primary endpoint was progression-free survival (PFS).
Both Talvey regimens delivered a profound PFS benefit. At a median follow-up of 24.6 months, and with baseline characteristics balanced across arms, hazard ratios (HRs) versus DPd were 0.28 (95% confidence interval [CI] 0.20–0.40) for Tal-DP and 0.33 (95% CI 0.24–0.46) for Tal-D, both p<0.0001. This translated to 24-month PFS rates of 81.3% (95% CI 75.8–85.7) for Tal-DP and 77.6% (95% CI 71.7–82.5) for Tal-D, versus 51.2% (95% CI 44.8–57.1) for DPd. Response endpoints also favored both Talvey arms: objective response rate (ORR) was 88.2% (Tal-DP) and 88.5% (Tal-D) versus 77.6% (DPd), with complete response or better (≥CR) rates of 71.1% and 68.9% versus 34.5%, and minimal residual disease (MRD)-negative ≥CR of 52.3% and 46.3% versus 15.9%. Importantly, OS likewise favored both Talvey arms, with HRs of 0.47 (95% CI 0.30–0.73) for Tal-DP and 0.51 (95% CI 0.33–0.78) for Tal-D.
Regarding the safety profile, adverse events (AEs) were manageable and consistent with each agent’s known profile. Tal-D doublet offers a distinct safety profile alongside comparable efficacy potentially allowing treatment of patients with specific comorbidities or health vulnerabilities that complicate other regimens.
J&J is presenting 30+ abstracts at EHA 2026, with key myeloma presentations pushing its bispecifics from late-line into earlier-line settings. Currently J&J is on both sides of the ongoing chimeric antigen receptor T cell (CAR-T)-versus-bispecific and B-cell maturation antigen (BCMA)-versus-GPRC5D sequencing debates. The company plans US and EU filings later in 2026, with Talvey potentially setting a new standard of care as early as 2L. Thus, Talvey is now moving into the same 2L space that J&J’s own BCMA bispecific, Tecvayli, targets through the MajesTEC-3 trial, on which its approval earlier this year was based.
MajesTEC-3d data sharpens Tecvayli’s differentiation
The Phase III MajesTEC-3 trial (NCT05083169) evaluated Tecvayli in patients with R/R MM and one to three prior lines of therapy. A total of 587 patients were randomised to Tecvayli plus daratumumab (Tec-Dara) versus daratumumab-based standard regimens (daratumumab–pomalidomide–dexamethasone [DPd] or daratumumab–bortezomib–dexamethasone [DVd]). In the trial, Tec-Dara demonstrated an unprecedented improvement in progression-free survival (PFS) (36-month hazard ratio [HR] of 0.17) and all key secondary endpoints, advancing Tecvayli from its prior accelerated FDA approval in the fourth line and later, toward a potential approval as a standard of care in as early as the second line. Following the FDA approval in March 2026, the combination has been listed by the US National Comprehensive Cancer Network (NCCN) as a category 1 preferred regimen for double refractory patients after one prior line in MM. The presented analysis aimed to characterise the efficacy of Tec-Dara across subgroups with and without high-risk cytogenetic abnormalities (HRCAs) and functional high-risk (FHR) status.
The data sharpen Tecvayli’s differentiation in an increasingly crowded field. High-risk cytogenetics and early functional relapse have long defined the most intractable MM populations, accounting for a disproportionate share of poor outcomes and unmet need. The consistency of the high-risk signal is therefore a meaningful differentiator that could underpin its broader adoption. Tec-Dara appears to blunt the adverse prognostic impact that has historically been seen in high-risk disease. However, the field is evolving rapidly and the standard of care can shift before readout with long trials. MajesTEC-3’s population was largely anti-CD38-naïve, and thus no longer reflective of real-world patients now that daratumumab quadruplets are the standard frontline therapy. MajesTEC-9 tackles this directly by enrolling a largely anti-CD38-refractory population, although it assesses Tecvayli as a monotherapy rather than in combination.
Tecvayli drives response in smoldering MM
Researchers from the Dana-Farber Cancer Institute, in collaboration with J&J, presented data from the Phase II ImmunoPRISM trial (NCT05469893). This trial tested Tecvayli in patients with high-risk smoldering MM – a pre-malignant stage of MM.
A total of 59 patients were enrolled in the trial, receiving either teclistamab (Tec) as monotherapy (n=45), or lenalidomide plus dexamethasone (LenDex) (n=14) for 12 or 24 cycles, respectively. The primary endpoint was complete response (CR), with secondary endpoints including minimal residual disease (MRD) negativity, progression-free survival (PFS), and safety. After a median follow up of 23.4 months, Tec-treated patients outperformed the LenDex group, with a CR rate of 73% versus 0%, and MRD negativity was achieved in 81% in the Tec arm versus 0% in the LenDex arm. The two-year PFS rates were 92% in the Tec arm and 51% in the LenDex arm. Cytokine release syndrome (CRS) was observed in 71.1% of patients in the Tec arm (all grade 1/2), while rates of grade 3 or higher adverse events—mainly neutropenia (36% versus 79%), thrombocytopenia (4% versus 14%), and infections (20% versus 21.4%)—were all lower in the Tec arm. These results support the claim that Tec may be a suitable intervention for high-risk SMM patients.
Questions remain about whether there will be interest in pursuing a label expansion with Tecvayli for this population. This would greatly extend J&J’s reach as the only provider of targeted therapies approved for the treatment of high-risk SMM. Commercially, Tecvayli is performing well in MM. GlobalData’s patient-based forecast estimates that Tecvayli will have global sales of $1.85bn by 2032. It remains to be seen whether there is a clear place for Tecvayli as a preventative agent in the pre-malignant market.
