Tecvayli-Talvey Combination Cuts Progression Risk 89% in Earlier-Line Multiple Myeloma

Johnson & Johnson reported positive topline results from the phase 3 MonumenTAL-6 trial, showing that Tecvayli (teclistamab-cqyv) combined with Talvey (talquetamab-tgvs) reduced the risk of disease progression or death by 89% and the risk of death by 62% in patients with relapsed or refractory multiple myeloma (RRMM) who had received one to four prior lines of therapy. The company said this hazard ratio is the lowest reported across any phase 3 study of bispecific therapies in RRMM to date.¹

What did the MonumenTAL-6 trial evaluate?

The 3-arm, global, randomized trial compared 2 investigational regimens against investigator's choice of standard of care in adults with RRMM who had received prior treatment with an anti-CD38 antibody and lenalidomide. The first arm paired Tecvayli with Talvey (Tec-Tal), and the second combined Talvey with pomalidomide (Tal-P). Both were measured against elotuzumab, pomalidomide, and dexamethasone or pomalidomide, bortezomib, and dexamethasone. The trial's primary endpoint was progression-free survival (PFS) as assessed by independent review committee, with key secondary endpoints including overall response rate, complete response or better, minimal residual disease-negative complete response, and overall survival.¹

"These findings add to a growing body of [p]hase 3 evidence evaluating the survival outcomes associated with the early use of immunotherapy doublets in the treatment journey," said Ajay K. Nooka, MD, MPH, director, Myeloma Program, Department of Hematology and Medical Oncology, Emory University School of Medicine, in a company press release.¹

How did the two regimens perform?

Both arms met the trial's primary PFS endpoint against standard of care. The Tec-Tal regimen reduced the risk of progression or death by 89% (hazard ratio [HR], 0.11; 95% confidence interval [CI], 0.08-0.16; p<.0001), while the Tal-P regimen reduced that risk by 73% (HR, 0.27; 95% CI, 0.2-0.35).¹ The safety profiles of both combinations were consistent with the known safety profiles of each drug used alone. Based on the strength of the interim data, the trial's independent data monitoring committee recommended unblinding the study at the first interim analysis. Full results are expected to be presented at a future medical meeting and shared with global health authorities.¹

Multiple myeloma is the third most common blood cancer worldwide,² with more than 180,000 new cases diagnosed globally each year³ and a 5-year survival rate of 59.8%.⁴ Tecvayli, a B-cell maturation antigen (BCMA)-targeting bispecific antibody, first received FDA accelerated approval in October 2022. In March 2026, FDA approved it in combination with daratumumab and hyaluronidase-fihj for use in patients who had received at least one prior line of therapy, extending its use earlier in the treatment journey.¹ More than 30,700 patients have been treated with Tecvayli worldwide.¹ Talvey, which targets G protein–coupled receptor class C group 5 member D (GPRC5D), received FDA accelerated approval in August 2023 and has since been used to treat more than 11,000 patients.¹

What does this mean for multiple myeloma treatment?

"At Johnson & Johnson, we have intentionally built a multiple myeloma portfolio that spans biological targets, mechanisms, modalities, and lines of therapy, giving physicians the flexibility to use our therapies across a diverse patient population and throughout the patient journey," said Yusri Elsayed, MD, MHSc, PhD, global therapeutic area head of oncology at Johnson & Johnson, in the release.¹ The company positioned the results as its fifth positive phase 3 study evaluating its T-cell-engaging multiple myeloma portfolio in the second-line setting, part of a broader effort to move immunotherapy-based regimens earlier in the disease course. MonumenTAL-6 (NCT06208150) is registered as an ongoing trial.¹

References

1. Johnson & Johnson. TECVAYLI + TALVEY reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myeloma. Press release. Published July 23, 2026. Accessed July 24, 2026. https://www.jnj.com/media-center/press-releases/tecvayli-talvey-reduced-the-risk-of-disease-progression-or-death-by-89-and-the-risk-of-death-by-62-in-earlier-line-relapsed-refractory-multiple-myeloma
2. City of Hope. Multiple myeloma. Updated July 20, 2022. Accessed July 24, 2026. https://www.cancercenter.com/cancer-types/multiple-myeloma
3. International Agency for Research on Cancer. Multiple myeloma fact sheet. World Health Organization. 2024. Accessed July 24, 2026. https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf
4. Surveillance, Epidemiology, and End Results Program. SEER*Explorer: an interactive website for SEER cancer statistics. National Cancer Institute. Accessed July 24, 2026. https://seer.cancer.gov/explorer/