Tecvayli Boosts Survival in Relapsed Multiple Myeloma: MajesTEC-9 Trial

For patients with multiple myeloma that has returned after initial treatments, immunotherapy has demonstrated the potential to significantly change the standard of care.

New data from the MajesTEC-9 Phase 3 clinical trial, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, revealed that Tecvayli (teclistamab) monotherapy reduced the risk of disease progression or death by 71% compared to standard-of-care treatments for patients with relapsed or refractory multiple myeloma.

The study evaluated Tecvayli, a bispecific antibody targeting both the B-cell maturation antigen (BCMA) on cancer cells and CD3 on T cells, against investigator-chosen regimens: either Pomalyst (pomalidomide), Velcade (bortezomib) and dexamethasone (PVd) or Kyprolis (carfilzomib) and dexamethasone (Kd).

The results were particularly meaningful for a patient population that had already been exposed to common therapies, including Revlimid (lenalidomide) and anti-CD38 monoclonal antibodies. Researchers noted a critical unmet need for this group, as their disease often becomes resistant to standard triplet or quadruplet drug regimens.

Significant survival gains

The primary goal of the study was to measure progression-free survival (PFS), or the length of time a patient lives without their cancer getting worse. The results showed a dramatic difference: the estimated 18-month PFS was 69.8% for those receiving Tecvayli, compared to 26.9% for those in the control group.

Beyond keeping the cancer at bay, Tecvayli also helped patients live longer. The study reported a significant improvement in overall survival, with a hazard ratio of 0.6, representing a 40% reduction in the risk of death compared to the standard treatments. This survival advantage remained clear even though more than two-thirds of the patients in the control group went on to receive other advanced therapies, such as CAR-T cell therapy, after their initial treatment failed.

"The significant PFS and OS advantage seen in MajesTEC-9 ... support [Tecvayli]-based therapy as a new 2L+ standard of care across practice settings," the researchers noted in their presentation.

Deeper, more durable responses

The depth of the response to Tecvayli was another highlight of the presentation. The overall response rate (ORR) reached 84.5% for patients on Tecvayli, while only 54.2% of patients in the control group responded to treatment.

Furthermore, nearly 66% of Tecvayli patients achieved a complete response or better, a rate nearly four times higher than the 16.8% seen in the control arm. Tecvayli also drove deeper molecular responses, with 38.5% of patients achieving minimal residual disease (MRD) negativity, meaning no cancer cells were detectable at a sensitivity of one in 100,000 cells.

The duration of these responses was also notable. While the median duration of response for the control group was 13.4 months, the median had not yet been reached for the Tecvayli group, with an estimated 80.6% of responders maintaining their response at the 18-month mark.

Impact on quality of life

For patients living with multiple myeloma, the burden of symptoms can be just as significant as the disease itself. The MajesTEC-9 trial used the MySlm-Q total symptom score to track how the treatment affected patients' daily lives.

Tecvayli was found to preserve health-related quality of life by significantly delaying the time it took for myeloma symptoms to worsen. The hazard ratio for symptom worsening was 0.50, meaning Tecvayli halved the risk of patients experiencing a decline in their physical well-being due to the cancer.

Safety and dosing

The safety profile of Tecvayli remained consistent with previous studies. The most common side effects included cytokine release syndrome (CRS), which occurred in 66% of patients. However, nearly all cases were grade 1 (mild) or 2 (moderate) and resolved without causing any patients to stop treatment.

Infections were also a frequent concern, affecting 82.8% of patients on Tecvayli. Grade 3 (severe) or 4 (life-threatening) infections occurred in 41.6% of the Tecvayli group. The data showed that these severe infections declined after the first six months of treatment, which researchers attributed to better disease control and the transition to less frequent dosing.

References:

“MajesTEC-9: A phase 3 randomized study of teclistamab monotherapy vs investigator’s choice of pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone (PVd/Kd) in patients (pts) with relapsed refractory multiple myeloma (RRMM)” by Dr. Roberto Mina, Presented at the 2026 American Society of Clinical Oncology Annual Meeting; May 29-June 2, 2026; Chicago, IL.

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