Real-World Teclistamab Shows Deep Responses in R/R Multiple Myeloma Cohort

Teclistamab-cqyv (Tecvayli) produced deep responses and maintained clinical benefit despite frequent missed doses in a small, predominantly minority, community-based population with relapsed/refractory multiple myeloma, according to a single-center retrospective analysis presented in a poster session at the 44th Annual Chemotherapy Foundation Symposium (CFS^®), hosted by Physicians’ Education Resource^®, LLC.¹ Across the 28-patient cohort, response rates were numerically higher than those reported in the registrational phase 1/2 MajesTEC-1 trial (NCT03145181; NCT04557098).

What were the response and survival outcomes?

Among the 28 patients treated with teclistamab at New York-Presbyterian Brooklyn Methodist Hospital, the overall response rate (ORR), the rate of very good partial response (VGPR) or better, and the rate of complete response (CR) or better were each numerically higher than the corresponding rates in MajesTEC-1 (n = 165), which the investigators characterized as deeper responses across every end point. The ORR was 75%, and a greater than CR occurred in 61% of the population.

The median progression-free survival (PFS) in the cohort was 8.0 months (95% CI, 3.8-11.7), which was numerically shorter than the MajesTEC-1 median of 11.3 months, although the confidence interval spanned the trial median. Data showed a median overall survival (OS) of 12.2 months.

How did the real-world population differ from MajesTEC-1?

The cohort reflected a population underrepresented in the registrational trial: 67% of patients were Black, compared with a 4% Black representation benchmark derived from 19 pooled multiple myeloma registrational trials. The analysis was conducted in a predominantly minority, community-based academic-affiliated setting that also included patients with higher ECOG performance status than those in MajesTEC-1, which was limited to an ECOG status of 0 to 1. Patients in the cohort had received a median of 2 prior lines of therapy, compared with 5 in MajesTEC-1, reflecting earlier use of teclistamab in this real-world setting.

What were the real-world safety findings?

Any-grade cytokine release syndrome (CRS) occurred in 54% of the population; 4% experienced grade 2 or higher events. Additionally, any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 11% of patients.

An analysis showed that infection correlated with an increased risk of mortality (HR, 4.02; 95% CI, 1.38-11.72; P = .011). Of 15 deaths, 9 were related to a relapse. Furthermore, patients with an ECOG performance status of 3 or higher experienced a significantly higher likelihood of grade 3 or higher infections at 83% vs 24% among those with lower performance statuses (odds ratio, 16.0; P = .015). Intravenous immunoglobulin prophylaxis correlated with fewer infections and longer OS at a median of 17.4 months vs 4.3 months (HR 0.23; 95% Cl 0.06-0.86. P = 0.018).

What was the impact of missed doses?

The mean relative dose intensity was 89.2%, and 67% of the evaluable population missed at least 1 dose. Despite this, missed doses did not appear to compromise outcomes. In a comparison of patients with at least 1 missed dose (n = 9) vs those with no missed doses (n = 9), the ORR was 89% in both groups (P = 1.00), the CR or better rate was 89% vs 78% (P = 1.00), and the rate of any-grade CRS was 56% vs 78% (P = .62). The investigators noted that missing doses changed neither response nor safety outcomes.

What is the clinical context?

Teclistamab is a BCMA/CD3 bispecific T-cell engager approved for relapsed/refractory multiple myeloma on the basis of the MajesTEC-1 trial.² Because multiple myeloma has a higher incidence in patients who are Black, a group that comprised only approximately 12% of MajesTEC-1 enrollment, the investigators examined the efficacy, safety, and impact of missed doses in a single-center cohort with a predominant minority population and higher ECOG performance status to assess real-world applicability in community settings.

According to the investigators, the analysis was limited due to its small sample size, retrospective trial design, and single-center work.

“In this real-world racially diverse cohort with a higher ECOG score than the MajesTEC-1 trial, response to [bispecific antibodies] was observed at 75%,” Susan Karass, DO, from the Division of Hematology and Oncology at New York-Presbyterian Brooklyn Methodist Hospital, wrote with coauthors in the poster.¹ “Further plans are to expand this trial to include a larger number of [patients] within these underrepresented groups treated with any type of [multiple] myeloma directed [bispecific antibodies] in [relapsed/refractory multiple myeloma].”

References

1. Karass S, Kassner J, Okobi T, et al. Real world safety and efficacy of teclistamab in relapsed/refractory multiple myeloma: a retrospective analysis of a single center experience in a predominantly minority population. Presented at the 44th Annual Chemotherapy Foundation Symposium (CFS®), hosted by Physicians’ Education Resource®, LLC; November 11-13, 2026; New York, NY. Abstract 19.
2. U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma. News release. FDA. October 25, 2022. Accessed November 11, 2026. https://tinyurl.com/bdem44ez