How Has Teclistamab Administration Translated Into Community MM Settings?

Teclistamab shows promising real-world effectiveness for relapsed/refractory multiple myeloma, with high response rates and manageable safety profiles.

Teclistamab-cqyv (Tecvayli) was proven to be a viable treatment and was approved for patients with relapsed/refractory multiple myeloma, based on results from a clinical trial—the phase 1/2 MajesTEC-1 trial (NCT03145181; NCT04557098).1,2

In MajesTEC-1, with a median follow-up of 14.1 months, teclistamab elicited an overall response rate (ORR) of 63.0%, with 39.4% of patients achieving a complete response (CR) or better. Further, 26.7% of patients had no minimal residual disease (MRD), and the rate of MRD negativity among patients who achieved a CR was 46%. The median progression-free survival (PFS) was 11.3 months (95% CI, 8.8-17.1).

Over the 2 years since teclistamab’s approval, data from real-world settings have accumulated. At the 22nd International Myeloma Society Annual Meeting in Toronto, Ontario, Canada, 2 posters were shared on real-world outcomes.3,4 Binod Dhakal, MD, an associate professor of medicine in the Division of Hematology at the Medical College of Wisconsin in Milwaukee, and Hans Lee, MD, the director of Multiple Myeloma Research at Sarah Cannon Research Institute in Nashville, Tennessee, came together as part of a CancerNetwork®-hosted Between The Lines program at the conference to discuss these new data.

Underlying the whole discussion, the importance of step-up dosing when administering teclistamab was emphasized by both doctors. Dhakal said that there are pros and cons to the dosing strategy: The foremost pro is that it helps maintain safety and mitigates risks of harmful adverse effects, and the foremost con is that it is logistically much more difficult.

Real-World Outcomes

One of the shared posters was an analysis of 36 patients with relapsed/refractory multiple myeloma who were treated with teclistamab at a large community oncology center, Texas Oncology.

On this poster, Lee said, “It does show proof of concept that bispecific antibodies can be administered to [patients with multiple myeloma] in the community. Despite a quarter of patients not being potentially trial eligible for the registrational MajesTEC-1 study, outcomes were quite good.”

In the overall cohort, the ORR was 74.0%, with 38.0% achieving a partial response (PR), 36.0% having a very good partial response (VGPR) or better, 18.0% having a CR, and 4.0% having a stringent CR. The 12-month PFS rate was 65.0%, and the 12-month OS rate was 75.0%. Neither the median PFS nor the median OS was reached.

In the Tec-1 eligible subgroup, which consisted of patients who would have been eligible for teclistamab per US prescribing information, the ORR was 75.0%, with 47.1% achieving a PR, 33.4% having a VGPR or better, 16.7% having a CR, and 2.8% having a stringent CR. The 12-month PFS and OS rates were 76.0% and 78.0%, respectively; neither the median PFS nor the median OS was reached. According to Dhakal, this analysis demonstrated that patients treated with teclistamab in community settings “experienced numerically comparable effectiveness and safety compared with those observed in the MajesTEC-1 trial” even though the study population was comprised of older patients with high-risk disease burden.

In the overall cohort, the median patient age was 72.5 years (IQR, 45-88); 46.0% and 6.0% of patients had ECOG performance statuses of 1 and 2, respectively; 36.0% had Revised International Staging System (R-ISS) stage III disease; and 46.0% had high cytogenetic risk. Additionally, while in the Tec-1 eligible subgroup, no patients had any prior BCMA exposure; however, in the overall cohort, 6.0% of patients did: 1 patient each was exposed to belantamab mafodotin-blmf (Blenrep), ciltacabtagene autoleucel (Carvykti), and idecabtagene vicleucel (Abecma).

When considering the safety profile, Dhakal said, “I was encouraged to see the very low rates of CRS [cytokine release syndrome], ICANS [immune effector cell–associated neurotoxicity syndrome], and even low rates of infections. The way it was done was consistent and standard [with] infection prophylaxis.”

During step-up dosing, only grade 1 or 2 CRS was observed, occurring in 38.0% of all patients and 47.2% of Tec-1 eligible patients. ICANS was experienced by 4% of the overall cohort and 5.6% of the Tec-1 eligible subgroup, all of which were grade 1 or 2 events. All CRS and ICANS events were resolved during step-up dosing.

Infections occurred in 68.0% of the overall population and 69.4% of the Tec-1 subgroup; in both cohorts, 46% of patients received at least one dose of intravenous immunoglobulin prophylaxis.

“It’s encouraging to see that these patients, even though they are treated in the academic center or tertiary center for the step-up dosing, can go back to the community, and still be [treated] safely,” said Dhakal.

“The main limitation is that this study is reflective of the early days of the administration of bispecific antibodies, and the practice of how we actually do step-up dosing continuously evolves,” said Lee.

Step-Up Dosing

The second abstract primarily focused on the types of dosing patients received and investigated patient outcomes associated with the shift toward hybrid and outpatient initiation of teclistamab. Lee said, “This abstract highlights the evolution of how we’re administering bispecific antibodies for [multiple] myeloma during the step-up dosing period.”

Of the 222 patients with relapsed/refractory multiple myeloma evaluated, 71 were included in an outpatient/hybrid (OP/HY) subgroup of patients who were treated by community providers. The ORR was 69.8% in the overall group and 77.5% in the OP/HY subgroup with a median follow-up of 5.4 months (range, 0.3-22.6) and 5.0 months (range, 1.1-22.6), respectively. The ORR continued to increase, with deepening responses, at 9 months.

The 6-month PFS rate was 76% (95% CI, 69%-82%) in the overall cohort and 65% (95% CI, 49%-77%) in the OP/HY subgroup; the 6-month OS rates were 82% (95% CI, 76%-87%) and 76% (95% CI, 61%-86%), respectively. As Dhakal noted, these results implied that there is no compromise in efficacy when a patient receives teclistamab in outpatient settings compared with inpatient settings.

Lee also added, “By and large in my clinic, I’d feel very comfortable doing outpatient step-up dosing for the majority of my patients.” He did state that, for some patient groups, such as those with higher disease burden or low blood cell counts, he leans toward admitting them.

The analysis was a retrospective, multicenter chart review study that included patients who initiated teclistamab from October 25, 2022, to January 5, 2025.

Of patients in the OP/HY subgroup, the median age was 63 years (range, 60-68), 52.4% had high cytogenetic risk, 21.1% had an ECOG performance status of 2 or 3, 32.4% had R-ISS stage II disease, and 77.5% were triple-class refractory. The median number of prior lines of therapy was 4 (range, 3-4).

Regarding safety, during step-up dosing, CRS events occurred in 33.3% of the overall cohort and 26.6% of the OP/HY subgroup; 2.3% and 2.8%, respectively, were grade 3 events. ICANS occurred in 5.4% and 4.2% of each respective group, with one grade 4 event occurring in the overall cohort.

Infections occurred in 14.9% of the overall cohort and 18.3% of the OP/HY subgroup; the majority of infections were grade 1 or 2, though 0.9% and 1.4% experienced grade 5 events.

“[Looking] at the CRS grade 2 and higher, this is comparable with both the cohorts, whether you are doing outpatient vs inpatient. That also tells you how safe this can be with close monitoring,” said Dhakal.

References

1. Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505. doi:10.1056/NEJMoa2203478

2. FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. FDA. October 25, 2022. Accessed September 25, 2025. https://tinyurl.com/3fajp7n9

3. Levy Y, Ensley L, Mahmud S, 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: 22nd International Myeloma Society Annual Meeting; September 17-20, 2025; Toronto, Canada. Abstract PA-020.

​4. Dhakal B, Ko G, He J, et al. Outcomes of teclistamab (tec) step-up dosing in outpatient/hybrid setting among a large sample of relapsed refractory multiple myeloma (RRMM) patients treated with tec​. Presented at: 22nd International Myeloma Society Annual Meeting; September 17-20, 2025; Toronto, Canada. Abstract PA-023.