Teclistamab-cqyv (Tecvalyi) monotherapy produced statistically significant improvements in progression-free survival (PFS) and overall survival (OS) vs standard-of-care (SOC) therapy in patients with relapsed or refractory multiple myeloma, the majority of which were refractory to anti-CD38 therapy and lenalidomide (Revlimid), according to topline findings from the investigational phase 3 MajesTEC-9 study (NCT05572515).1
In this patient population, teclistamab reduced the risk of disease progression or death by 71% (HR, 0.29; 95% CI, 0.23-0.38) and reduced the risk of death by 40% (HR, 0.60; 95% CI, 0.43-0.83), with benefit observed as early as the second-line setting. Additionally, the safety profile of teclistamab monotherapy was manageable with established mitigation protocols and aligned with the agent’s known tolerability profile, with no new safety signals observed.
These results build on prior findings from the investigational phase 3 MajesTEC-3 study (NCT05083169), which similarly demonstrated the clinical potential of teclistamab in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro).1,2 The combination led to a 83% reduction in the risk of disease progression or death at nearly 3 years of follow-up (HR, 0.17; 95% CI, 0.12-0.23; P < .0001).
"The MajesTEC-9 results reinforce the potential of teclistamab to transform treatment earlier in the multiple myeloma journey, with an immunotherapy regimen widely available for all appropriate patients, including those commonly treated in the community setting," Roberto Mina, MD, an associate professor at Winship Cancer Institute of Emory University, shared in a news release.1 "The impressive results show a significant improvement in PFS and OS as a monotherapy in patients with refractory multiple myeloma, and together with the MajesTEC-3 results, help establish teclistamab as an essential therapy for patients as early as first relapse."
Topline efficacy findings from MajesTEC-9 were confirmed at the first prespecified interim analysis, and the Independent Data Monitoring Committee recommended unblinding the trial based on the strength of the results. Full phase 3 data are expected to be presented at an upcoming medical meeting and submitted to global health authorities.
MajesTEC-9: Key Takeaways
•Teclistamab monotherapy improved PFS and OS vs standard of care therapy in patients with relapsed/refractory multiple myeloma.
•Benefit with the agent was seen as early as the second line in a largely anti-CD38/lenalidomide-refractory population.
•These findings build on prior data from MajesTEC-3, which demonstrated the efficacy of teclistamab plus daratumumab and hyaluronidase-fihj; the agent’s safety profile as monotherapy was also consistent with prior data and no new safety signals were reported.
What was the design of the MajesTEC-9 trial?
MajesTEC-9 was a phase 3 study designed to compare the efficacy of teclistamab with SOC regimens in adults with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy.1 Key eligibility criteria included prior exposure to an anti-CD38 monoclonal antibody and lenalidomide, aligning enrollment with contemporary treatment sequencing. The majority of patients were refractory to anti-CD38 therapy (85%) and lenalidomide (79%); more than 90% were refractory to their most recent line of therapy.
In part 1, patients were randomly assigned to receive either teclistamab or investigator’s choice of pomalidomide (Pomalyst), bortezomib (Velcade), and dexamethasone (PVd) or carfilzomib (Kyprolis) and dexamethasone (Kd).3 Part 2 was designed to further characterize the safety and efficacy of an alternative teclistamab dosing strategy.
"Teclistamab continues to break new ground as a first-in-class bispecific T-cell engager antibody and the MajesTEC-9 results are the latest example of Johnson & Johnson's commitment to provide critical treatment options for patients at every stage of their disease," Yusri Elsayed, MD, MHSc, PhD, global therapeutic head of Oncology at Johnson & Johnson Innovative Medicine, shared in a news release.1 "In addition to the other transformational therapies in our multiple myeloma portfolio, we continue to redefine the future for patients, bringing us another step closer to cure."
References
- Tecvayli monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide. Johnson and Johnson. News Release. January 14, 2026. Accessed January 15, 2026. https://www.jnj.com/media-center/press-releases/tecvayli-monotherapy-demonstrates-superior-progression-free-and-overall-survival-versus-standard-of-care-as-early-as-first-relapse-in-patients-with-multiple-myeloma-predominantly-refractory-to-anti-cd38-therapy-and-lenalidomide
- Unprecedented results from the Phase 3 MajesTEC-3 study support Tecvayli plus Darzalex Faspro as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma. Johnson and Johnson. News Release. JDecember 9, 2025. Accesssed January 15, 2026. https://www.jnj.com/media-center/press-releases/unprecedented-results-from-the-phase-3-majestec-3-study-support-tecvayli-plus-darzalex-faspro-as-a-potential-standard-of-care-as-early-as-second-line-for-patients-with-relapsed-refractory-multiple-myeloma
- A study comparing teclistamab monotherapy versus pomalidomide, bortezomib, dexamethasone (PVd) or carfilzomib, dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma (MajesTEC-9). Clinicaltrials.gov Updated December 19, 2025. Accessed January 15, 2026. https://clinicaltrials.gov/study/NCT05572515
