Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients with Relapsed or Refractory Multiple Myeloma Receiving Teclistamab: A Panel Chart Review Study.

Key Summary Points

Introduction

Multiple myeloma (MM) is an incurable malignancy [ 1 ], with an estimated 36,110 new myeloma cases diagnosed in 2025 in the USA [ 2 ]. Data have shown differences in mortality by gender for MM (male patients 7.9 deaths per 100,000 versus female patients 4.6 deaths per 100,000) [ 3 ]. Prior to the approval of bispecific antibody (BsAb) treatments for MM, patients with progressive relapsed or refractory MM (RRMM) had a median overall survival (OS) of approximately 8 months and median progression-free survival (PFS) of 3–4 months [ 4 , 5 ].

Teclistamab is an established standard of care BsAb that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells for the treatment of adult patients with RRMM. It is indicated as monotherapy for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody (triple-class exposure), or in combination with daratumumab for patients with at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent [ 6 ]. The first approval of teclistamab monotherapy was supported by the findings from the MajesTEC-1 trial, a phase 1/2 study evaluating teclistamab efficacy and safety in patients with RRMM [ 7 , 8 ]. In this study, teclistamab demonstrated an overall response rate (ORR) of 63.0% at a median follow-up of 30.4 months [ 8 ]. The median duration of response (DoR) was 24.0 months, with a median PFS of 11.4 months and a median OS of 22.2 months [ 8 ]. With the inclusion of the MajesTEC-1 Asian cohort, median DoR was extended to 26.7 months, median PFS was extended to 15.1 months, and median OS was extended to 26.3 months [ 9 ].

All BsAbs for myeloma are associated with an increased risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), particularly during treatment initiation [ 10 ]. Cytokine release caused by T cell activation may trigger an inflammatory cascade resulting in these adverse events [ 10 ]. Grade 1/2 CRS typically involves fever, hypotension not requiring vasopressors, and hypoxia requiring only low-flow oxygen. In contrast, grades 3/4 CRS involve hypotension necessitating vasopressors and hypoxia requiring high-flow oxygen, with the most critical cases needing positive pressure ventilation [ 6 ]. Grade 1/2 ICANS corresponds to an Immune Effector Cell Encephalopathy (ICE) score of 3–9, with patients remaining alert or responsive to voice. Grade 3/4 ICANS is marked by an ICE score of 0–2, depressed consciousness, and may include seizures, focal motor weakness, or cerebral edema; cases can be life‑threatening and may require urgent neuro‑intervention [ 6 ]

Teclistamab is initiated using a step-up dosing approach by administering smaller, incremental doses before reaching the full therapeutic dose to mitigate the risk of CRS and ICANS. In the MajesTEC-1 trial, CRS and ICANS were reported in 72.1% and 3.0% of patients, respectively (primarily grade 1 or 2; no discontinuations) [ 7 ]. Anti-BCMA BsAbs are also associated with an elevated rate of infection that remains throughout treatment [ 7 , 11 ]. In the long-term analysis of the MajesTEC-1 trial with a median follow-up of 30.4 months, 78.8% of patients experienced infections while receiving teclistamab (grade 3/4, 55.2%; grade 5, 13.3%). The onset of new grade ≥3 infections generally declined over time; factors such as transitioning to biweekly dosing and increasing use of immunoglobulin replacement may have contributed to this trend [ 8 ].

Comparisons between the MajesTEC-1 trial and real-world data suggest that teclistamab provides improved outcomes compared with physician’s standard choice of therapy [ 12 – 14 ]. While clinical trials have stringent eligibility criteria and the United States Prescribing Information (USPI) label outlines specific indications for teclistamab use, a broader and more diverse patient population may receive treatment with teclistamab in real-world practice. Therefore, capturing data on the real-world patient populations receiving teclistamab is essential to better understand its use and outcomes outside of the controlled setting of clinical trials. Although real-world studies have assessed subgroups consistent with MajesTEC-1 trial eligibility criteria [ 15 , 16 ], no published data have been generated on the outcomes of teclistamab treatment in USPI-aligned (met MajesTEC-1 trial criteria and treated per USPI in terms of patient eligibility criteria and treatment dosing) and USPI-unaligned subgroups. Additionally, in the USA there are limited long-term outcomes data on teclistamab safety and effectiveness in the real world, particularly in the community setting [ 17 – 20 ].

To address these evidence gaps, we conducted this analysis of patients with RRMM treated with teclistamab monotherapy primarily within US community-oncology settings. This study aimed to evaluate the real-world effectiveness and safety of teclistamab with extended follow-up. Outcomes were analyzed overall and in subgroups of patients who were USPI-aligned and USPI-unaligned to validate the findings of the MajesTEC-1 trial in the real world.

Methods

Study Design

This was a retrospective, observational, multisite cohort study using a medical chart review of patients with RRMM predominantly being managed by community oncology providers in the USA. Patients were identified through Cardinal Health’s US-based Oncology Provider Extended Network (OPEN), which includes over 7000 oncologists, hematologists, and other healthcare providers for the purpose of research, data collection, and communication within the oncology field, including categorizing real-world tumor response [ 21 ]. The study included patients treated with teclistamab on or after the US Food and Drug Administration (FDA) approval date of 25 October 2022, and data cutoff was 7 May 2025. Data are presented here from the overall population, and the subgroups of patients with baseline characteristics that were aligned with teclistamab USPI criteria (USPI-aligned subgroup) and were not aligned with the USPI criteria (USPI-unaligned subgroup). The pre-index period was defined as the time before the index date (index date; defined as first dose of teclistamab). The follow-up period (defined as the time from the index date until last follow-up or date of death) includes a step-up dosing period (defined as time from the first step-up dose of teclistamab to the first treatment dose), and the treatment period.

Ethics Compliance

All physicians in OPEN are able to participate in research overseen by a central institutional review board (IRB). This study was exempt from review by an IRB because the database is compliant with the Health Insurance Portability and Accountability Act (HIPAA), does not involve interaction or interview with any patients, and does not include any individually identifiable data. As such this study is not research involving human patients, as defined in 45 CFR 46.102(f)(2). This study used existing fully de-identified data and the investigators cannot be identified, directly or through identifiers linked to patients, and therefore is exempt from all 45 CFR part 46 requirements.

Patients

Patients were included if they had a confirmed diagnosis of RRMM as reported by the abstracting provider, initiated teclistamab on or after 25 October 2022, and were ≥18 years of age on the date of teclistamab initiation. Patients were excluded if they received teclistamab treatment for RRMM as part of a clinical trial. Criteria defining the USPI-aligned subgroup are listed in Supplementary Table 1 . Patients who did not meet the inclusion criteria for the USPI-aligned subgroup were included in the USPI-unaligned subgroup. No patients were excluded on the basis of sex/gender.

Data Collection and Assessment

Patient and clinical characteristics are described for the pre-index period and/or at initiation of teclistamab. Patient demographics reported included age, sex (as assigned at birth), and race/ethnicity. Clinical characteristics reported included prognostic risk (physician-reported International Staging System [ISS] and Revised ISS [R-ISS] category), and cytogenetic risk (high-risk cytogenetic mutations included t(4;14), t(14;16), t(14;20), del(17p), gain(1q21): 3 copies of 1q21, and/or amp(1q21): ≥4 copies of 1q21) at initial MM diagnosis. Abstracting providers were instructed to provide R-ISS score, and if unavailable, ISS score. Eastern Cooperative Oncology Group Performance Status (ECOG PS) was collected at initiation of teclistamab.

Information was collected on treatment history including the number of previous lines of therapy, systemic therapy history, and stem cell therapy history. Data collected on treatment patterns included line of therapy in which teclistamab was received, treatment setting, dosing frequency changes, duration of treatment, discontinuation status, and reasons for discontinuation.

Clinical outcomes reported included ORR, DoR, time to first response, time to best response, PFS, and OS. ORR was calculated for best disease response to teclistamab according to International Myeloma Working Group criteria (IMWG) [ 22 ] and was defined as partial response (PR) or better (i.e., stringent complete response [sCR] plus CR plus very good PR [VGPR] plus PR). Response rates of VGPR or better and CR or better were also reported. DoR was defined as time from physician-reported first (or best if first is not available) response (sCR, CR, VGPR, or PR) during teclistamab therapy to physician-reported disease progression or death. Time to first and best response was calculated among patients who responded as time from initiation of teclistamab to physician-reported first or best response. Specific laboratory values were not included as part of the chart review CRF; however, a rigorous validation and quality check was carried out with providers for any discrepancies or abnormal data. Although laboratory tests were not mandated, there were rigorous checks and most practices within the OPEN network followed good practices and confirmed CR/sCR with bone marrow biopsy or, alternatively, responses were assessed using scans and peripheral blood assessments (further detail available in the Results and Discussion ). PFS was calculated from the date of teclistamab initiation until the earliest of either physician-reported date of disease progression or death. OS was calculated as time between teclistamab therapy initiation and the date of death. For PFS and OS, patients without an event were censored at the date of the last patient visit.

Incidence and severity of CRS, ICANS and infection events, and primary prophylaxis for prevention of adverse events, were reported. CRS and ICANS were graded using physician documentation, with validation and quality checks to reconcile discrepancies.

Statistical Analysis

This was a descriptive analysis of retrospective patient-level data. The target sample size for this cohort of patients was 100, based on estimates during a feasibility assessment series, as well as estimated dates of data collection. All variables were summarized using frequency counts and proportions for dichotomous and categorical variables, while measures of centrality (mean, median) and spread (minimum, maximum, standard deviation [SD], interquartile range [IQR], as appropriate) were used for continuous variables. Time-to-event outcomes were assessed using the Kaplan–Meier method. Study results were reported across the entire study population and for subgroups of interest. All data processing and analyses were performed in SAS v9.4.

Results

Patient Characteristics

Physicians abstracted data for 101 patients. Baseline characteristics are presented in Table 1 . Median (IQR) age at teclistamab initiation was 65.4 (61.6–69.4) years, 7.9% of patients were older than 75 years, 65.3% of patients were male, 25.7% were Black, and 65.3% were White. Most patients (86.1%) had an ECOG PS score of 1 at initiation of teclistamab and 37.6% of patients had high-risk cytogenetic abnormalities at MM diagnosis. ISS scores were reported for 14.9% of patients while R-ISS scores were reported for 75.3% of patients. Among these, 33.3% had stage 3 ISS score and 56.6% had stage 3 R-ISS scores at diagnosis of MM (Table 1 ). In this real-world cohort, 29.7% of patients were USPI-aligned ( n = 30), and 70.1% of patients were USPI-unaligned ( n = 71). The USPI-aligned subgroup was slightly younger and had a higher proportion of patients with ECOG PS 1, stage 3 R-ISS, and high-risk cytogenetics than in the USPI-unaligned subgroup (Table 1 ). The most frequent reasons patients did not meet the USPI criteria were having received fewer than four prior lines of therapy and having a dosing frequency reduction from weekly prior to being in CR for at least 6 months (Supplementary Table 2 ). Overall, 6.9% of patients had extramedullary disease, all of whom were in the USPI-unaligned cohort. Comorbidities in the overall population included anemia (32.7%), renal impairment or failure (23.8%), hypogammaglobulinemia (9.9%), and congestive heart failure (3.0%) (Table 1 ).

Treatment History

Patients in the overall population had a median (IQR) 4 (3–4) lines of therapy prior to teclistamab initiation (Table 1 ). Most patients (93.1%) were triple-class exposed with 9.9% having prior exposure to anti-BCMA therapies. Among those with prior anti-BCMA exposure ( n = 10), 80.0% had received an anti-BCMA chimeric antigen receptor (CAR) T cell therapy (idecabtagene vicleucel or ciltacabtagene autoleucel) and 40.0% had previously been treated with an anti-BCMA antibody–drug conjugate (belantamab mafodotin-blmf). Median (IQR) time from last anti-BCMA therapy to teclistamab initiation was 9.6 (8.3–14.0) months. In the overall population, 65.3% of patients were triple-class refractory, 54.5% of patients were penta-class refractory, and 62.4% of patients had previously undergone an autologous stem cell transplant (Table 1 ).

Treatment Patterns

Median follow-up from initiation of teclistamab was 13.8 months in the overall population, 14.7 months in the USPI-aligned subgroup, and 13.3 months in the USPI-unaligned subgroup. All patients completed step-up dosing; 67.3% received all step-up doses in an inpatient setting, 24.8% received all step-up doses in an outpatient setting, and 6.9% received step-up doses in a mix of inpatient and outpatient settings (hybrid setting). The setting of step-up dosing was unknown for 1.0% of patients. Most patients were treated in community settings (overall 74.3%; USPI-aligned 60.0%; USPI-unaligned 80.3%), with the remaining proportion in academic settings (overall 25.7%; USPI-aligned 40.0%; USPI-unaligned 19.7%).

Overall, 58.4% of patients remained on teclistamab treatment for the study duration, and median (95% confidence interval [CI]) treatment duration for teclistamab was 24.3 (11.1–not estimable [NE]) months. Full details of teclistamab discontinuation are provided in Supplementary Table 3 . In the overall population, 18 (17.8%) patients had their teclistamab dosing schedule reduced to a frequency less than weekly, with a median (IQR) time to switch of 4.8 (1.8–6.6) months from teclistamab initiation.

Effectiveness

ORR for best response was 80.2%, 90.0%, and 76.1% in the overall population, the USPI-aligned subgroup, and the USPI-unaligned subgroup, respectively (Table 2 ). VGPR or better rates were 55.4%, 46.7%, and 59.2% in the overall population, the USPI-aligned subgroup, and the USPI-unaligned subgroup, respectively (Fig. 1 ). All response-evaluable patients with prior anti-BCMA therapy exposure ( n = 7) had a PR or better (PR = 14.3%; VGPR = 42.9%; CR = 14.3%; sCR = 28.6%). In the overall population and both subgroups, objective response rate and other response measures increased with extended treatment duration (Fig. 1 ) while responses deepened over time (Fig. 2 a–c). Among the overall cohort, median (IQR) time to first response (defined as PR or better) was 3.3 (1.9–4.0) months and median (IQR) time to best response was 3.8 (2.1–5.4) months. Median DoR was not reached for all populations. Median PFS was not reached in the overall population and the USPI-aligned subgroup; median PFS (95% CI) was 15.9 (10.0–NE) months in the USPI-unaligned subgroup (Fig. 3 a–c). For all populations, median OS was not reached (Fig. 4 a–c). The estimated PFS (95% CI) and OS (95% CI) rates at 12 months for the overall population were 65.0% (54.1%−73.9%) and 80.6% (70.9–87.4), respectively. PFS and OS rates were maintained at 15 months (62.3% [51.2–71.5%] and 77.9% [67.7–85.2%], respectively), and at 18 months (57.7% [45.7–68.0%] and 71.9% [58.7–81.5%], respectively). The 12-, 15-, and 18-month PFS and OS rates for the USPI-based subgroups were similar to the overall population and are shown in Table 2 .

Safety

During the step-up dosing period, 32.7%, 43.3%, and 28.2% of patients experienced at least one CRS event in the overall population, the USPI-aligned subgroup, and USPI-unaligned subgroup, respectively; most CRS events were grade 1 (Table 3 ). Primary prophylaxis with tocilizumab during the step-up dosing period to prevent CRS was administered to 4.0% of patients in the overall population, all of whom were in the USPI-unaligned subgroup and did not experience any CRS events (Table 3 ). After completion of step-up dosing, 5.0% of patients experienced at least one CRS event (all grade 1) during the treatment period. No patients discontinued teclistamab because of CRS and all CRS events were reported to have resolved.

Of the 8.9% of patients who experienced ICANS events during step-up dosing, almost all were grade 1 or 2, with one grade 3 event reported. Results were similar in the USPI-aligned and USPI-unaligned subgroups (Table 3 ). During the treatment period, two (2.0%) patients experienced ICANS (one grade 1 event and one grade 3 event). All cases of ICANS were reported to have resolved, and no patients discontinued teclistamab because of ICANS.

In the overall population, USPI-aligned subgroup, and USPI-unaligned subgroup, infections were reported in 26.7%, 16.7%, and 31.0% of patients while receiving treatment (including step-up dosing) with teclistamab, respectively (Table 3 ). Among reported infections with known grade, most were grade 1 or 2, with two grade 3 events in the USPI-unaligned subgroup. Two patients (2.0%) discontinued teclistamab because of infections and all other infection events resolved. Most patients (74.3%) received at least one form of primary prophylaxis for infection prevention, including 38.6% of patients who received at least one dose of intravenous immunoglobulin (IVIG) (Table 3 ). The percentage of patients who did not receive any form of primary prophylaxis for infections was higher in the USPI-aligned subgroup (40.0%) than the USPI-unaligned subgroup (19.7%) although IVIG administration for primary prophylaxis was higher in the USPI-unaligned subgroup (43.7% vs 26.7%). Further details on infections are summarized in Supplementary Table 4 . Other treatments and supportive care administered for management of CRS, ICANS, and infections are reported in Supplementary Table 5 .

Discussion

This real-world chart review study conducted in the USA evaluated the effectiveness and safety of patients initiating teclistamab primarily within community oncology settings. Notably, this is the first study to assess outcomes in both USPI-aligned and USPI-unaligned populations, providing an evaluation of the clinical characteristics and outcomes for real-world populations resembling those enrolled in the MajesTEC-1 trial and treated per USPI as well as those treated in real-world practice who would not have met MajesTEC-1 trial and USPI criteria.

In this study, the ORR was numerically higher in the USPI-aligned subgroup than the USPI-unaligned subgroup (90.0% vs 76.1%, respectively), which could be driven by a more stringent inclusion criteria for the USPI-aligned population (e.g., more patients in the USPI-unaligned group had ECOG PS>1, extramedullary disease, or prior anti-BCMA exposure). However, as a result of the descriptive nature of this study, the comparison of USPI-aligned and USPI-unaligned patients is not statistically powered, and these results warrant careful interpretation. At a median follow-up of 13.8 months, ORRs across all study populations were numerically higher in this study than in the MajesTEC-1 trial (63.0%). These findings are striking given that the patients in this real-world study had a higher disease burden at initial MM diagnosis and worse performance status at teclistamab initiation than those enrolled in the MajesTEC-1 clinical trial [ 7 , 11 ]. The proportion of PRs among overall best responses in this study is higher than in MajesTEC-1 (24.8% vs 4.2%) while the CR or better rate was lower (35.6% vs 46.1%) [ 7 ]. These observed differences are likely due to longer median follow-up in the MajesTEC-1 study and more rigorous adjudication of CRs in a clinical trial setting. In the real-world setting it is possible that response measurements are less frequently and stringently (e.g., lack of bone marrow confirmation for CR or better) conducted compared to clinical trials. Patients who had responded or whose response deepened may not have been assessed prior to end of follow-up leading to potential underreporting of CR and sCR. The numerically higher ORR observed in the USPI-aligned subgroup compared to the MajesTEC-1 clinical trial may be due to differences in patient baseline characteristics (no USPI-aligned patients had extramedullary disease vs 17.0% in MajesTEC-1) and prior treatment history (MajesTEC-1 trial population had a median of one additional prior line of therapy and a higher proportion of triple-class refractory patients) [ 7 ]. A recently published international multicenter retrospective study of patients with RRMM treated with teclistamab at nine academic centers reported an ORR of 89.4% within a MajesTEC-1 eligible subgroup, which is similar to that observed in the USPI-aligned subgroup although median follow-up in this study was only 5.3 months [ 16 ]. A separate study of patients treated in a consortium of 15 US academic centers reported an ORR of 61.0% among MajesTEC-1 trial eligible patients with a median follow-up of 10.1 months [ 15 ]. Additional real-world teclistamab studies predominantly conducted in academic settings have reported ORRs ranging from 59.3% to 66.0% among the overall study populations [ 17 – 19 ]. Patient characteristics in these real-world studies may have had an impact on the observed differences in outcomes as the patients in these academic studies were generally older, more heavily pre-treated, and had higher disease burden than the cohort reported here [ 15 – 19 ]. Consistent with this pattern, a separate retrospective analysis using Flatiron Health’s oncology electronic health records reported an ORR of 62.2% among patients treated with teclistamab in academic settings and 81.3% in community-treated patients, with the latter group presenting with lower disease burden and fewer prior treatments [ 23 ]. Median time to first response in this study (3.3 months) was longer than in the MajesTEC-1 trial (1.8 months), which may be due to response measurements being less frequent in this real-world study compared to a clinical trial.

In this study, the deepening of responses at 3, 6, 9, and 12 months to teclistamab was observed in all patient populations, consistent with the MajesTEC-1 trial [ 7 , 11 ]. Considering that responses continue to deepen at median follow-up of 13.8 months in this population, studies with longer follow-up periods are warranted to gain a full assessment of response to teclistamab in real-world settings.

In this study, there was a numerically higher incidence of CRS in the USPI-aligned subgroup than in the USPI-unaligned subgroup. This is a descriptive study with limited sample size for the USPI-aligned subgroup and should be interpreted with caution. In the MajesTEC-1 trial, CRS was reported in 72.0% of patients [ 7 ]. In contrast, low rates and grades of CRS (all grade 1/2) were seen in the overall (32.7%), USPI-aligned (43.3%), and USPI-unaligned (28.2%) populations in this real-world analysis. The rates of CRS observed in this study were also lower than other real-world studies investigating MajesTEC-1 eligible populations, where CRS rates were reported at 54.0% [ 15 , 16 ]. It should be recognized that grade 1 CRS events such as fever (temperature ≥100.4 °F or 38 °C) may not be documented by all treating physicians; therefore, low-grade CRS events are likely to be underreported in the real world, especially in patients who receive step-up dosing in the outpatient setting. Conversely, the incidence of ICANS (overall 8.9%; USPI-aligned 10.0%; USPI-unaligned 8.4%) in this study was comparable to rates reported in other real-world studies (7.3–11.0%) [ 15 , 16 ], but was numerically higher in the USPI-aligned subgroup compared to the USPI-unaligned subgroup. Although the MajesTEC-1 trial also reported the overall incidence of neurologic toxicities, this analysis focused on ICANS events, which are more precisely captured in real-world data compared to broader and less consistently reported neurologic complications. Despite this, ICANS may be overreported in real-world settings, as certain symptoms (such as mild tremor, confusion, agitation, seizures, and cerebral edema) that occur more frequently in the elderly may be misclassified as ICANS events [ 24 ]. Furthermore, these symptoms of low-grade ICANS may be more concerning to patients [ 24 ] and may be more likely to be reported than CRS symptoms (e.g., low-grade fever) [ 25 ].

Low rates of infections were observed in the overall (26.7%), USPI-aligned (16.7%), and USPI-unaligned (31.0%) populations in this study, with a numerically higher incidence of infection in the USPI-unaligned subgroup compared to the USPI-aligned subgroup. These infection rates are lower than those reported in the MajesTEC-1 trial and previous real-world studies where rates ranged from 42.0% to 76.4% [ 7 , 15 , 16 ]. This discrepancy may be attributable to several factors. The MajesTEC-1 clinical trial was conducted during the COVID-19 pandemic, which may have impacted the incidence and management of infections. Additionally, there may be underreporting of low-grade adverse events in real-world settings, but severe events are likely to be captured as most patients were followed up regularly by their treatment provider when receiving teclistamab. Clinical practice patterns have evolved since the approval of teclistamab by the FDA, and prophylactic measures, informed by institutional protocols and treatment guidelines, are now recommended. Outcomes reported here may reflect the impact of these practices, including those incorporated into the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) [ 26 – 28 ]; the lower rates of infections observed in this study relative to the MajesTEC-1 trial may reflect this. The results of this study should be interpreted in these contexts and may not be generalizable to all populations. However, it is notable that 38.6% of patients in this study received at least one dose of IVIG as primary prophylaxis for infections management. It is possible that administration of primary prophylaxis is underreported in the real world and the dosing frequency may differ from MajesTEC-1. However, recommendations for the monitoring, prophylaxis, and treatment of infections have been developed [ 26 , 27 ] and findings of this study suggest that further improvements to infection prevention protocol implementations in real-world settings may help reduce infection rates.

The results of this study should be interpreted considering certain limitations. The limited sample size of the USPI-aligned subgroup warrants careful interpretation of these patients’ outcomes. Subgroup analyses by sex/gender were not carried out as part of this study. As the purpose of this study was to characterize outcomes in the treated population rather than to evaluate differential effects across demographic subgroups, sex/gender-stratified analyses were not pre-specified. Given the limited sample size of the study, such analyses would not yield reliable or clinically meaningful insights. Although physicians were required to record all patient experiences in the medical charts, chart data are subject to potential omissions and errors in data entry. Additionally, some data that may be important, such as immunoglobulin isotypes, were not available. Response data reported in this study should be interpreted carefully, as response measurements were conducted based on provider discretion and may be less frequent than the structured assessment schedule used in the MajesTEC-1 clinical trial. Furthermore, treatment responses in this study are provider-reported per IMWG criteria, but providers were not asked to give specific laboratory values to validate results. All (100.0%) CR and sCR rates were assessed via bone marrow biopsy for the USPI-aligned subgroup, and 80.0% of CR and sCR rates were confirmed by providers to have been assessed via bone marrow biopsy (scans [46.7%] and peripheral blood assessments [73.3%] were also conducted for response assessments; data not shown) in the USPI-unaligned subgroup, which may have an impact on the interpretation of response rates as overreporting is possible.

Conclusions

This study demonstrated that teclistamab had favorable clinical outcomes in heavily pretreated patients with RRMM treated primarily in the community oncology settings, despite having higher disease burden and worse performance status than patients in the MajesTEC-1 clinical trial. Notably, USPI-aligned patients exhibited a high ORR, supporting the findings of MajesTEC-1 in real-world settings. Safety outcomes were primarily low-grade, with all CRS and ICANS being resolved. These findings underscore that teclistamab is an effective treatment option for RRMM patients in real-world settings and administration is feasible in community-based settings.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 365 KB)

Acknowledgements

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Medical Writing, Editorial, and Other Assistance

Editorial assistance was provided by Emily Eagles of ESP Medical Communications Ltd and supported by Johnson & Johnson.

Author Contributions

Binod Dhakal, Moshe Y Levy, Gilbert Ko, Jinghua He, Nina Kim, Wenze Tang, Tonya Le Blanc, Jessica Fowler, Sarah Lucht, Madison Brown, Emily Bland, Camryn Craig, Sarah Giegerich, JaLyna Laney, Bruce Feinberg, Niodita Gupta-Werner, Shuchita Kaila, and Peter Voorhees meet the ICMJE criteria for authorship, and have contributed to the development of the manuscript, and read and approved the final version for submission and agree to be accountable for the work.

Funding

Johnson & Johnson provided financial support for the study and funded the journal’s Rapid Service Fee. Johnson & Johnson participated in the approval of the manuscript.

Data Availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Declarations

Conflicts of Interest

Binod Dhakal received research funding from Arcellx, BMS, C4 Therapeutics, Caribou Biosciences, CARsgen, Gracell, Janssen, Menarini and Sanofi; received honoraria from BMS, Janssen and Karyopharm; served on advisory boards for Arcellx, BMS, Genentech, GSK, Janssen, Karyopharm, Kite, Menarini, Pfizer and Sanofi. Moshe Y Levy is a speaker/consultant for Johnson & Johnson. Gilbert Ko, Jinghua He, Nina Kim, Wenze Tang, Tonya LeBlanc, Jessica Fowler, Niodita Gupta-Werner, and Shuchita Kaila are employees of Johnson & Johnson and may hold stock options and/or shares in Johnson & Johnson. Sarah Lucht, Camryn Craig, Bruce Feinberg, Madison Brown, Emily Bland, Sarah Giegerich, and JaLyna Laney are employees of Cardinal Health, which received fees from Johnson & Johnson for the conduct of this research. Peter Voorhees received honoraria for advisory boards from AbbVie Inc, Ascentage Pharma, AstraZeneca, Bristol-Myers Squibb, GSK, Johnson & Johnson, Kite, Pfizer, Regeneron and Sanofi.

Ethical Approval

All physicians in OPEN are able to participate in research overseen by a central institutional review board (IRB). This study was exempt from review by an IRB because the database is compliant with the Health Insurance Portability and Accountability Act (HIPAA), does not involve interaction or interview with any patients, and does not include any individually identifiable data. As such this study is not research involving human patients, as defined in 45 CFR 46.102(f)(2). This study used existing fully de-identified data and the investigators cannot be identified, directly or through identifiers linked to patients, and therefore is exempt from all 45 CFR part 46 requirements.

Footnotes

Prior Publication: Data from this study has been previously published as an abstract titled ‘Real-world Patient Characteristics and Outcomes in Patients With Relapsed or Refractory Multiple Myeloma Receiving Teclistamab Across Community Oncology Practices in the US’ at the 68th American Society of Hematology 2024 Meeting; [San Diego, California; December 7-10, 2024], poster number PA-023. This publication provides updated data with extended follow-up and additional subgroup analyses.

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Associated Data

Supplementary Materials

Supplementary file1 (PDF 365 KB)

Data Availability Statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.