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Cited by 1,269Multiple Myeloma Research and TreatmentsMonoclonal and Polyclonal Antibodies ResearchProtein Degradation and Inhibitors

Teclistamab in Relapsed or Refractory Multiple Myeloma

Open access
Moreau, Philippe, Garfall, Alfred L., van de Donk, Niels W.C.J., Nahi, Hareth, San-Miguel, Jesús F., Oriol, Albert, Nooka, Ajay K., Martin, Thomas +26 more·2022·New England Journal of Medicine
DOI 10.1056/nejmoa2203478PMC PMC10587778
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Abstract

BACKGROUND: Teclistamab is a T-cell-redirecting bispecific antibody that targets both CD3 expressed on the surface of T cells and B-cell maturation antigen expressed on the surface of myeloma cells. In the phase 1 dose-defining portion of the study, teclistamab showed promising efficacy in patients with relapsed or refractory multiple myeloma. METHODS: In this phase 1-2 study, we enrolled patients who had relapsed or refractory myeloma after at least three therapy lines, including triple-class exposure to an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. Patients received a weekly subcutaneous injection of teclistamab (at a dose of 1.5 mg per kilogram of body weight) after receiving step-up doses of 0.06 mg and 0.3 mg per kilogram. The primary end point was the overall response (partial response or better). RESULTS: Among 165 patients who received teclistamab, 77.6% had triple-class refractory disease (median, five previous therapy lines). With a median follow-up of 14.1 months, the overall response rate was 63.0%, with 65 patients (39.4%) having a complete response or better. A total of 44 patients (26.7%) were found to have no minimal residual disease (MRD); the MRD-negativity rate among the patients with a complete response or better was 46%. The median duration of response was 18.4 months (95% confidence interval [CI], 14.9 to not estimable). The median duration of progression-free survival was 11.3 months (95% CI, 8.8 to 17.1). Common adverse events included cytokine release syndrome (in 72.1% of the patients; grade 3, 0.6%; no grade 4), neutropenia (in 70.9%; grade 3 or 4, 64.2%), anemia (in 52.1%; grade 3 or 4, 37.0%), and thrombocytopenia (in 40.0%; grade 3 or 4, 21.2%). Infections were frequent (in 76.4%; grade 3 or 4, 44.8%). Neurotoxic events occurred in 24 patients (14.5%), including immune effector cell-associated neurotoxicity syndrome in 5 patients (3.0%; all grade 1 or 2). CONCLUSIONS: Teclistamab resulted in a high rate of deep and durable response in patients with triple-class-exposed relapsed or refractory multiple myeloma. Cytopenias and infections were common; toxic effects that were consistent with T-cell redirection were mostly grade 1 or 2. (Funded by Janssen Research and Development; MajesTEC-1 ClinicalTrials.gov numbers, NCT03145181 and NCT04557098.).

Integrity signals

Registry

Crossref · 10.1056/nejmoa2203478

Cites

25 of 25 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

8 of 18 cited sources checked · 5 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    Higher-grade cytokine release syndrome and neurotoxic events have been described after CAR-T administration in patients with multiple myeloma.

    “In contrast, higher-grade cytokine release syndrome and neurotoxic events have been described after CAR-T administration in patients with multiple myeloma.6,8”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [6] source
    • cites [8] source
  • Findingown data

    Among 165 patients who received teclistamab, 77.6% had triple-class refractory disease.

    “Among 165 patients who received teclistamab, 77.6% had triple-class refractory disease (median, five previous therapy lines).”
    • Also stated in: § PATIENTS · plain
      “Before study entry, 148 patients (89.7%) had resistance to the previous line of therapy, 128 (77.6%) had triple-class refractory disease, and 50 (30.3%) had penta-drug refractory disease.”
    Quote in the paperNot a substantial claim
  • Findingown data

    The overall response rate was 63.0% (104 of 165 patients; 95% CI, 55.2 to 70.4).

    “Responses occurred in 104 of 165 patients (63.0%; 95% confidence interval [CI], 55.2 to 70.4).”
    • Also stated in: § RESULTS · plain
      “the overall response rate was 63.0%”
    Quote in the paperSubstantial claim
  • Findingown data

    The median duration of progression-free survival was 11.3 months (95% CI, 8.8 to 17.1).

    “The median duration of progression-free survival was 11.3 months (95% CI, 8.8 to 17.1)”
    • Also stated in: § RESULTS · plain
      “The median duration of progression-free survival was 11.3 months (95% CI, 8.8 to 17.1).”
    Quote in the paperSubstantial claim
  • Findingown data

    The Kaplan-Meier estimate of maintenance of response for at least 12 months was 68.5% (95% CI, 57.7 to 77.1).

    “The Kaplan–Meier estimate of maintenance of response for at least 12 months was 68.5% (95% CI, 57.7 to 77.1).”
    Quote in the paperSubstantial claim
  • May combine two claims. 31
  • Classified as probably not a substantial claim. 12

  • May combine two claims.

    Premisecitation

    CAR-T therapy requires that patients have access to specialized care centers and can wait the minimum 4-week period for production, which can result in attrition rates of approximately 10 to 15%.

    “CAR-T therapy requires that patients have access to specialized care centers and can wait the minimum 4-week period for production, which can result in attrition rates of approximately 10 to 15%,6-8”
    Quote in the paperSubstantial claim2 of 3 sources checked
    • cites [6] source

      The Patients section (page not available) reports that 12 of 140 enrolled patients discontinued before ide-cel infusion, an attrition rate of about 8.6%, and that some patients received bridging therapy during manufacturing. It does not establish a minimum four-week production period, a requirement for access to specialized care centers, or that waiting caused the discontinuations. (LLM, conf=0.85)

      Experimental — accuracy not yet measured
    • cites [7] source

      The Discussion and future perspectives section (page unavailable) says CAR T-cell treatment involves a specialized center and that manufacturing takes several days to weeks, during which disease may progress. It does not establish a minimum four-week production period or an attrition rate of approximately 10–15%. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [8] source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Absence of minimal residual disease has been associated with improved overall survival and progression-free survival in patients with myeloma.

    “Such absence of minimal residual disease has been associated with improved overall survival and progression-free survival in patients with myeloma.14-16”
    Quote in the paperNot a substantial claim2 of 3 sources checked
    • cites [14] source
    • cites [15] source
    • cites [16] source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Adverse events were graded according to NCI CTCAE version 4.03, except CRS and ICANS, which were graded according to ASTCT criteria.

    “Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03), except for cytokine release syndrome (Table S2) and immune effector cell–associated neurotoxicity syndrome, which were graded according to the criteria of the American Society for Transplantation and Cellular Therapy.12”
    Quote in the paperNot a substantial claim1 of 1 sources checked

  • Classified as probably not a substantial claim.

    Study design and conductcitation

    The primary end point of the phase 2 study was overall response rate, defined as partial response or better according to IMWG criteria, as assessed by an independent review committee.

    “The primary end point of the phase 2 study was the overall response rate, which was defined as a partial response or better according to the criteria of the International Myeloma Working Group, as assessed by an independent review committee”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [10] source

      The Response criteria section recommends IMWG criteria for clinical trials and endorses the IMWG definition of partial response; the Minimal response section also distinguishes partial response or better from minimal response. The paper does not establish that overall response rate was the primary endpoint of the particular phase 2 study or that an independent review committee assessed it (pages not provided). (LLM, conf=0.87)

      Experimental — accuracy not yet measured
    • cites [11] source

  • May combine two claims.

    Interpretationcitation

    Of the 19 deaths due to adverse events in this study, 12 were attributed to Covid-19, which was consistent with the higher mortality observed from Covid-19 in patients with hematologic cancers during this time frame.

    “Of the 19 deaths due to adverse events in our study, 12 were attributed to Covid-19, which was consistent with the higher mortality observed from Covid-19 in patients with hematologic cancers during this time frame.24”
    Quote in the paperNot a substantial claim1 of 1 sources checked

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The median number of previous therapy lines was 5.

    “median, five previous therapy lines”
    • Also stated in: § PATIENTS · plain
      “Patients had received a median of 5 previous lines of therapy (range, 2 to 14)”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Teclistamab exposure was sustained over the predetermined target level of 6 μg per milliliter with a low peak-to-trough ratio.

    “Teclistamab exposure was sustained over the predetermined target level (6 μg per milliliter, based on the upper boundary of an experimentally determined range of the 90% maximal effective concentration) with a low peak-to-trough ratio (Fig. S3).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Cytokine release syndrome occurred in 119 patients (72.1%); most events were grade 1 or 2, with one grade 3 event and no grade 4 events.

    “Cytokine release syndrome occurred in 119 patients (72.1%). Most events occurred after step-up and cycle 1 doses, with 6 patients (3.6%) having cytokine release syndrome in cycle 2 or later. Most events of cytokine release syndrome were grade 1 or 2 in severity and fully resolved, except for one grade 3 event”
    • Also stated in: § RESULTS · plain
      “cytokine release syndrome (in 72.1% of the patients; grade 3, 0.6%; no grade 4)”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Response rates were lower in patients with extramedullary disease, stage III disease, and at least 60% marrow replacement by plasma cells, and higher in those who had received no more than three previous lines of therapy.

    “Response rates were lower in patients with extramedullary disease, stage III disease, and at least 60% marrow replacement by plasma cells and were higher in those who had received no more than three previous lines of therapy.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Thrombocytopenia occurred in 66 patients (40.0%); grade 3 or 4 thrombocytopenia occurred in 21.2%.

    “thrombocytopenia (in 66 [40.0%])”
    • Also stated in: § RESULTS · plain
      “thrombocytopenia (in 40.0%; grade 3 or 4, 21.2%)”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    A total of 68 patients (41.2%) died; 41 deaths were attributed to progressive disease, 19 to adverse events including 12 from Covid-19, and 5 were considered by investigators to be related to teclistamab.

    “A total of 68 patients (41.2%) died, with most deaths (41) attributed to progressive disease (Table S9). Nineteen patients died from adverse events, including 12 deaths from coronavirus disease 2019 (Covid-19). Five deaths were considered by investigators to be related to teclistamab”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Reductions in soluble BCMA levels occurred during the first 4 cycles in 63 of 72 evaluable patients (88%) who had a partial response or better, whereas all 9 evaluable patients who did not have a response had increased levels.

    “In addition, reductions in soluble BCMA levels occurred during the first 4 cycles of treatment in 63 of 72 evaluable patients (88%) who had a partial response or better, whereas all the evaluable patients who did not have a response (9 of 9 patients) had increased levels of soluble BCMA.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    A total of 98 patients (59.4%) received at least 6 months of teclistamab treatment, and 79 patients (47.9%) received at least 9 months.

    “A total of 98 patients (59.4%) received at least 6 months of teclistamab treatment, and 79 patients (47.9%) received at least 9 months of treatment.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    All 165 patients reported an adverse event; grade 3 or 4 adverse events occurred in 156 patients (94.5%).

    “All 165 patients reported having an adverse event (Table 2 and Table S5), which were grade 3 or 4 in 156 patients (94.5%).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Five patients had a total of 9 events of immune effector cell-associated neurotoxicity syndrome, all grade 1 or 2; 7 were concurrent with cytokine release syndrome, and all resolved without discontinuation or dose reduction.

    “Five patients had a total of 9 events of immune effector cell–associated neurotoxicity syndrome, all either grade 1 or 2. Of these 9 events, 7 were concurrent with cytokine release syndrome, and all 9 events resolved without discontinuation or dose reduction.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Neutropenia occurred in 117 patients (70.9%); grade 3 or 4 neutropenia occurred in 64.2%.

    “neutropenia (in 117 patients [70.9%])”
    • Also stated in: § RESULTS · plain
      “neutropenia (in 70.9%; grade 3 or 4, 64.2%)”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Injection-site reactions were reported in 60 patients (36.4%); all such events were grade 1 or 2.

    “Injection-site reactions were reported in 60 patients (36.4%); all such events were grade 1 or 2.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The median time until onset of cytokine release syndrome was 2 days after the most recent dose, and the median duration was 2 days.

    “The median time until the onset of cytokine release syndrome was 2 days (range, 1 to 6) after the most recent dose, and the median duration was 2 days (range, 1 to 9).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Neurotoxic events occurred in 24 patients (14.5%), including immune effector cell-associated neurotoxicity syndrome in 5 patients (3.0%; all grade 1 or 2).

    “Investigator-assessed neurotoxic events, including immune effector cell–associated neurotoxicity syndrome, were reported in 24 patients (14.5%).”
    • Also stated in: § RESULTS · plain
      “Neurotoxic events occurred in 24 patients (14.5%), including immune effector cell–associated neurotoxicity syndrome in 5 patients (3.0%; all grade 1 or 2).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Anemia occurred in 86 patients (52.1%); grade 3 or 4 anemia occurred in 37.0%.

    “anemia (in 86 [52.1%])”
    • Also stated in: § RESULTS · plain
      “anemia (in 52.1%; grade 3 or 4, 37.0%)”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The median time until the first response was 1.2 months, and the median time until a best response was 3.8 months.

    “The median time until the first response was 1.2 months (range, 0.2 to 5.5), and the median time until a best response was 3.8 months (range, 1.1 to 16.8).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    One patient had a dose reduction during cycle 21 because of recurrent neutropenia, and 104 patients (63.0%) skipped a dose because of adverse events; two patients discontinued teclistamab because of adverse events.

    “One patient had a dose reduction during cycle 21 because of recurrent neutropenia, and 104 patients (63.0%) skipped a dose because of adverse events. Two patients discontinued teclistamab because of adverse events (grade 3 adenoviral pneumonia and grade 4 progressive multifocal leukoencephalopathy).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    As of March 16, 2022, 70 patients (42.4%) were continuing to receive treatment, with a median treatment duration of 8.5 months.

    “As of March 16, 2022, 70 patients (42.4%) were continuing to receive treatment (Fig. S1), with a median treatment duration of 8.5 months (range, 0.2 to 24.4).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Infections occurred in 126 patients (76.4%); grade 3 or 4 infections occurred in 74 patients (44.8%).

    “Infections occurred in 126 patients (76.4%); 74 patients (44.8%) had grade 3 or 4 infections.”
    • Also stated in: § RESULTS · plain
      “Infections were frequent (in 76.4%; grade 3 or 4, 44.8%).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    The overall depth of response was highlighted by the observation that 26.7% of patients had no minimal residual disease at a sensitivity level of 10^-5; these patients made up 82% of those in whom minimal residual disease could be evaluated.

    “The overall depth of response was highlighted by the observation that 26.7% of the patients were found to have no minimal residual disease at a sensitivity level of 10−5; these patients made up 82% of those in whom minimal residual disease could be evaluated.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    Cytopenias and infections were common, and toxic effects consistent with T-cell redirection were mostly grade 1 or 2.

    “Cytopenias and infections were common; toxic effects that were consistent with T-cell redirection were mostly grade 1 or 2.”
    • Also stated in: § DISCUSSION · plain
      “Toxic effects were also common but were mainly of low grade and reversible.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The sponsor established a safety evaluation team to monitor patient safety throughout the phase 1 study, and in phase 2 safety was monitored through continuous review by the sponsor.

    “The sponsor established a safety evaluation team to monitor patient safety throughout the phase 1 study. In phase 2, safety was monitored through continuous review by the sponsor.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    Subgroup analyses suggest that patients who have received no more than three previous therapy lines may have a better response rate than those who have received more than three therapies, supporting the use of teclistamab in earlier therapy lines.

    “In addition, subgroup analyses suggest that patients who have received no more than three previous therapy lines may have a better response rate than those who have received more than three therapies, a finding that supports the use of teclistamab in earlier therapy lines (although the confidence intervals for this finding are wide).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Teclistamab redirects CD3+ T cells to BCMA+ myeloma cells, resulting in T-cell activation and subsequent lysis and death of BCMA+ cells.

    “Teclistamab redirects CD3+ T cells to BCMA+ myeloma cells, resulting in T-cell activation and subsequent lysis and death of BCMA+ cells.18”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [18] source

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines of the International Council for Harmonisation.

    “The study was conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Council for Harmonisation.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    Toxic effects were common but mainly of low grade and reversible.

    “Toxic effects were also common but were mainly of low grade and reversible.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The median relative dose intensity was high, and dose reductions and discontinuations owing to adverse events were infrequent.

    “The median relative dose intensity was high, and dose reductions and discontinuations owing to adverse events were infrequent.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    The safety and efficacy populations included all patients who had received at least one dose of teclistamab at the recommended phase 2 dose in phase 1 or phase 2 as of September 7, 2021.

    “The safety and efficacy populations for this analysis included all the patients who had received at least one dose of teclistamab at the recommended phase 2 dose in phase 1 or phase 2 as of September 7, 2021.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Response rates were compared across various prespecified subgroups, including those defined according to cytogenetic risk, refractory status, and number of previous lines of therapy.

    “Response rates were also compared across various prespecified subgroups, including those defined according to cytogenetic risk, refractory status, and number of previous lines of therapy.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    A sample size of 100 patients would provide a power of at least 85% to establish an overall response rate of more than 30% at a one-sided significance level of 0.025, assuming an overall response rate of at least 45%.

    “For phase 2, we determined that a sample size of 100 patients would provide a power of at least 85% to establish an overall response rate of more than 30% at a one-sided significance level of 0.025, assuming an overall response rate of at least 45%.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationcitation

    Adverse events in this trial were common and included low-grade cytokine release syndrome and grade 3 or 4 cytopenia and infection in a patient population with increased susceptibility to infection due to myeloma-associated immunodeficiency and immunosuppressive effects of previous therapies.

    “Adverse events in this phase 1–2 trial were common and included low-grade cytokine release syndrome and grade 3 or 4 cytopenia and infection in a patient population that has an increased susceptibility to infection due to the immunodeficiency associated with myeloma and immunosuppressive effects of previous myeloma therapies.23”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [23] source

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Minimal residual disease negativity was assessed by next-generation sequencing of bone marrow aspirate DNA with a threshold of 10^-5.

    “Negativity for minimal residual disease was assessed by next-generation sequencing of DNA obtained from bone marrow aspirate (clonoSEQ assay, version 2.0 [Adaptive Biotechnologies]) with a threshold of 10−5 cells.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The study protocol, amendments, and relevant documents were approved by the local independent ethics committee or institutional review board at each study site, and all patients provided written informed consent.

    “The study protocol, amendments, and relevant documents were approved by the local independent ethics committee or institutional review board at each study site. All the patients provided written informed consent.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    All authors affirm that the trial was conducted in accordance with the study protocol and vouch for the accuracy and completeness of the data.

    “All the authors affirm that the trial was conducted in accordance with the study protocol and vouch for the accuracy and completeness of the data.”
    Quote in the paperNot a substantial claim
39 of 39

  • The paper relies on this without support.

    Teclistamab is readily available.

    “Teclistamab is readily available and has been associated with rapid onset of response after a median of approximately 1 month of treatment.”

  • The paper relies on this without support.

    No CD3-redirecting therapy has been approved for the treatment of myeloma.

    “Although clinical proof of concept has been obtained for other CD3-redirection platforms in other indications,19-21 no CD3-redirecting therapy has been approved for the treatment of myeloma.”

  • The paper relies on this without support.

    Cross-trial comparisons are challenging to interpret owing to differences in study design and patient populations.

    “Although cross-trial comparisons are challenging to interpret owing to differences in study design and patient populations, the response rates observed with teclistamab (63%) compare favorably with those of belantamab mafodotin”
3 of 3

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Teclistamab and elranatamab are BCMA-targeting bispecific antibodies approved for use in patients with relapsed myeloma who have received at least 4 prior regimens.

    “Two BCMA-targeting bispecific antibodies, teclistamab and elranatamab, have been approved for use in patients with relapsed myeloma who have received at least 4 prior regimens.91,92”

    From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [91]

    The Discussion explicitly says that no CD3-redirecting therapy had been approved for myeloma, contrary to the approval claim attributed to this paper. It confirms that teclistamab targets BCMA, but the Methods describe trial eligibility after at least three prior therapy lines, not an approval criterion of at least four regimens. Page numbers were not supplied in our copy. (LLM, conf=0.88)

    Checked by a reasoning model — may be wrong.

    Experimental — accuracy not yet measured

  • A number of BCMA-directed therapies, including belantamab mafodotin, idecabtagene vicleucel, ciltacabtagene autoleucel and teclistamab, have shown efficacy in clinical trials and are approved for treatment of relapsed or refractory multiple myeloma.

    “A number of BCMA-directed therapies, including belantamab mafodotin, idecabtagene vicleucel (ide-cel), ciltacabtagene autoleucel (cilta-cel) and teclistamab, have shown efficacy in clinical trials and are approved for the treatment of relapsed or refractory multiple myeloma4–9.”

    From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [4]

    Split into 2 atoms — 1 confirmed, 0 partially supported, 1 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

    Checked by a reasoning model — may be wrong.

    Experimental — accuracy not yet measured

  • Patients with advanced disease stage (R-ISS stage III) have consistently shown poorer outcomes irrespective of the therapy received.

    “Similarly, patients with advanced disease stage (R-ISS stage III) have consistently shown poorer outcomes irrespective of the therapy received4–6,19–22.”

    From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [4]

    The Results (Efficacy; page not provided) report lower response rates among patients with stage III disease receiving teclistamab. However, the Results (Patients) identify the staging measure as the International Staging System, not R-ISS, and the Discussion notes that this small subgroup had wide confidence intervals. This single-treatment finding does not establish consistently poorer outcomes irrespective of therapy. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • In comparison to other BCMA-targeted T-cell-redirecting therapies, the rate of hematologic AEs with elranatamab was similar or lower after a similar follow-up.

    “In comparison to other BCMA-targeted T-cell-redirecting therapies, the rate of hematologic AEs with elranatamab was similar or lower after a similar follow-up4–6.”

    From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [4]

    The Results > Safety passage reports hematologic adverse-event rates for teclistamab, and Results > Efficacy gives a median follow-up of 14.1 months. These provide comparator data, but this paper does not report elranatamab rates or establish that they were similar or lower after a similar follow-up. Page numbers are unavailable in our copy. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • The response rate and DOR in MagnetisMM-3 were favorable to belantamab mafodotin (ORR 32%, median DOR 11.0 months and median PFS 2.8 months) after a median follow-up of 12.4 months.

    “and favorable to the BCMA-targeting antibody–drug conjugate, belantamab mafodotin (ORR 32%, median DOR 11.0 months and median PFS 2.8 months) after a median follow-up of 12.4 months4,9,19,23.”

    From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [4]

    The Discussion (page unavailable) says teclistamab’s 63% response rate compared favorably with belantamab mafodotin’s 31%, supporting the direction of the comparison and approximately the quoted 32% ORR. It does not give belantamab’s 11.0-month DOR, 2.8-month PFS, or 12.4-month follow-up. The Results > Efficacy passage (page unavailable) instead reports 14.1 months of follow-up for this teclistamab study. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

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Authors
Moreau, P., Garfall, A. L., van de Donk, N. W. C. J., Nahi, H., San-Miguel, J. F., Oriol, A., Nooka, A. K., Martin, T., Rosinol, L., Chari, A., Karlin, L., Benboubker, L., Mateos, M.-V., Bahlis, N., Popat, R., Besemer, B., Martínez-López, J., Sidana, S., Delforge, M., Pei, L., Trancucci, D., Verona, R., Girgis, S., Lin, S. X. W., Olyslager, Y., Jaffe, M., Uhlar, C., Stephenson, T., Van Rampelbergh, R., Banerjee, A., Goldberg, J. D., Kobos, R., Krishnan, A., & Usmani, S. Z.
Affiliations
  • Karolinska University Hospital (SE)
  • From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d’Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d’Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) — all in France; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.L.G.), and Janssen Research and Development, Spring House (R.V., S.G., S.X.W.L., C.U., T.S., A.B.) — both in Pennsylvania; the Department of Hematology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam (N.W.C.J.D.); Karolinska University Hospital at Huddinge, Stockholm (H.N.); Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Instituto de Investigación Sanitaria de Navarra, Pamplona (J.F.S.-M.), Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Puj...
  • City Of Hope National Medical Center (US)
  • Memorial Sloan Kettering Cancer Center (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2022-08-11
Volume
387
Issue
6
Pages
495-505
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2203478
PMC
PMC10587778
OpenAlex
W4282033105
Cited by
1,269
References
25
Citations by year
2026: 335 · 2025: 341 · 2024: 320 · 2023: 231 · 2022: 39 · 2013: 1
FWCI
169.47
Type
journal article
Language
en
Open access
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
  • PubMed Central (acceptedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
  • Lirias (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
Funders
Janssen Research & Development, LLC
Topics
  • Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
Keywords
teclistamab, relapsed/refractory multiple myeloma, bispecific T-cell engagers, overall response rate, minimal residual disease negativity, progression-free survival, cytokine release syndrome, neurotoxicity, dose-limiting toxicity, subcutaneous administration, immunotherapy safety and efficacy
MeSH terms
Antineoplastic Agents, Immunological, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Humans, Injections, Subcutaneous, Multiple Myeloma, Neoplasm Recurrence, Local, Recurrence, T-Lymphocytes, CD3 Complex, Antibodies, Bispecific, B-Cell Maturation Antigen, Antibodies, Monoclonal, Humanized

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

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