Teclistamab for R/R MM Effective and Safe When Administered in a Community Setting

In a real-world setting of relapsed/refractory multiple myeloma, teclistamab (Tecvayli; Janssen Biotech) produced high overall response rates among older adult patients who were heavily pretreated and had a high disease burden, with investigators from a community oncology practice noting outcomes comparable to patients from the MajesTEC-1 trial (NCT04557098).^1,2

B-cell maturation antigen (BCMA) x CD3 bispecific antibody, first-in-class teclistamab received an accelerated approval from the FDA on October 25, 2022, for adults with MM who have received at least 4 earlier lines of therapy.³ Because most current data on teclistamab come from academic oncology centers even though most US patients who have MM are treated at community oncology practices, the present study authors from Texas Oncology were seeking real-world community data. They looked at patient clinical characteristics and teclistamab dosing patterns, safety outcomes, and effectiveness.

Fifty patients made up the study population who had at least 1 recorded MM diagnosis, per International Classification of Disease, Tenth Revision, Clinical Modification code, and at least 1 record of teclistamab administration between October 26, 2022, and December 31, 2024. A subgroup of 36 of these patients were eligible for teclistamab according to US Prescribing Information (triple-class exposed, 4 prior lines of therapy, Eastern Cooperative Oncology Group performance status of 0/1, no prior anti-BCMA therapy). The median (IQR) age for both groups was 72.5 (45-88) years, and most patients were aged 65 or older than 75 (overall, 74%; subgroup, 77.7%), a White race (70.0% and 86.1%, respectively), and had commercial or Medicare Advantage as their primary insurance (74.0% and 69.4%). They were followed from the date of their first teclistamab step-up dose to last activity, death, or data cutoff, whichever was earliest.

Seventy-six of the total study cohort and 81% of the subgroup were referred to another institution for inpatient step-up dosing, the authors wrote, but everyone returned for the first teclistamab dose.

Overall response rates were 74% for the entire study population and 73% in the teclistamab-eligible cohort. Estimated progression-free survival (PFS) rates were 65% and 76%, respectively, and 12-month overall survival (OS) rates were 75% and 78%. Median PFS and OS were not reached.

Breaking down the overall response rates, these results were seen for the entire study population and the teclistamab-eligible cohort, respectively:

• Partial response: 38.0% and 41.7%
• Very good partial response: 14.0% and 13.9%
• Complete response: 18.0% and 16.7%
• Stringent complete response: 4.0% and 2.8%

During step-up dosing, cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) were seen, and all cases were resolved. However, there were slight differences between the overall group and the teclistamab-eligible cohort. There were higher rates of grade 1 and grade 2 CRS in the teclistamab group vs overall (38.9% and 8.3% vs 32.0% and 6.0%), but equal rates of ICANS (2.8% and 2.0% for both grades and groups).

Supportive care for CRS comprised acetaminophen and tocilizumab (6.0% overall and 8.3% subgroup for both drugs), dexamethasone (4.0% and 5.6%), diphenhydramine (2.0% and 0%), tocilizumab plus dexamethasone (2.0% and 2.8%), antibiotics (4.0% and 5.6%), other steroids (2.0% and 2.8%), and unknown (12.0% and 13.9%). Supportive care for ICANS was dexamethasone in 4.0% and 5.6%.

Infections during teclistamab treatment were also seen in 68.0% of overall patients and 69.4% of the teclistamab-eligible subgroup, with the median time to infection being shorter in the latter: 40 (range, 6-405) days vs 27.5 (range, 6-405) days. Primary prophylaxis was antivirals in 94.0% and 91.7%, respectively; antibiotics in 46.0% and 38.9%; intravenous immunoglobulin (IVIg) in 46.0% and 47.2%; antifungals in 10.0% and 11.1%; and granulocyte colony-stimulating factor in 8.0% and 8.3%. Primary treatment was IVIg in 12.0% and 13.9%, and the most common treatment setting was on an outpatient basis in 48.0% and 41.7%.

The median follow-up for this analysis was 14.3 months.

“Overall,” the investigators concluded, “patients treated with [teclistamab] in community settings experienced numerically comparable effectiveness and safety outcomes as compared with the MajesTEC-1 trial, despite being elderly with high-risk cytogenetics, high-disease burden, and heavily pretreated.”

References

1. Levy Y, Mahmud S, Lisi M, et al. Real-world outcomes among patients (pts) with relapsed or refractory multiple myeloma (RRMM) initiating teclistamab (Tec) at a large community oncology center in the US. Presented at: International Myeloma Society Annual Meeting; September 17-20, 2025; Toronto, Canada. Poster PA-020.
2. Mattina C. FDA approves first bispecific antibody, teclistamab, for R/R multiple myeloma. AJMC^®. October 26, 2022. Accessed September 21, 2025. https://www.ajmc.com/view/fda-approves-first-bispecific-antibody-teclistamab-for-r-r-multiple-myeloma