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P907: EFFICACY AND SAFETY OF ELRANATAMAB IN HIGH-RISK PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: A SUBGROUP ANALYSIS FROM MAGNETISMM-3

2023· article· en· W4385698049 on OpenAlexaff
Cyrille Touzeau, Nizar J. Bahlis, Christopher Maisel, Lionel Karlin, Asya Varshavsky‐Yanovsky, Eric Leip, Umberto Conte, Andrea Viqueira, Sarah Larson

Bibliographic record

VenueHemaSphere · 2023
Typearticle
Languageen
FieldMedicine
TopicMultiple Myeloma Research and Treatments
Canadian institutionsInstitute of Cancer ResearchUniversity of Calgary
Fundersnot available
KeywordsMedicineInternal medicineDiscontinuationMultiple myelomaRefractory (planetary science)LenalidomideOncologyCohortSurgeryGastroenterology

Abstract

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Topic: 14. Myeloma and other monoclonal gammopathies - Clinical Background: Data from the ongoing phase 2 MagnetisMM-3 (NCT04649359) study demonstrated the efficacy and safety of elranatamab in patients with relapsed/refractory multiple myeloma (RRMM) and no prior BCMA-directed therapy (Cohort A). Aims: To report the efficacy and safety of elranatamab in high-risk subgroups in BCMA-naïve patients from MagnetisMM-3. Methods: Eligibility criteria, dosing and administration were previously reported (Bahlis, ASH 2022). Subgroups analyzed were Revised International Staging System (R-ISS) stage (I/II/III), cytogenetic abnormalities (standard/high risk [high-risk defined by the presence of t(4;14), t(14;16) or del(17p)]), extramedullary disease (EMD) at baseline (Y/N), bone marrow plasma cell involvement (BMPC) at baseline (<50%/≥50%), and penta-refractory disease (Y/N). Results include data up through ~12 months after last patient initial dose. Results: Median treatment durations and the proportions of patients receiving treatment at the data cut-off were lower for all high-risk subgroups than the corresponding lower-risk subgroups (Table). The most frequent cause of discontinuation was progressive disease which was higher for all high-risk subgroups than the corresponding lower risk subgroups. A clinical benefit, assessed by the objective response rate (ORR), was observed across subgroups (Table). A multivariable logistic regression analysis for ORR including baseline age, Eastern Cooperative Oncology Group, sex, region, cytogenetic risk, presence of EMD, BMPC involvement, prior stem cell transplant, R-ISS stage, number of prior lines, type of myeloma, and penta-refractory disease showed presence of EMD at baseline and non-IgG myeloma (vs IgG) as predictive of lower ORR. Light chain-only myeloma (vs IgG) was predictive of higher ORR. Median duration of response (DOR) was not reached in subgroups by 12 months, DOR rate at 12 months is reported in the Table. Any-grade treatment-emergent adverse events (TEAEs) were reported in 100% of patients in the study. The incidence of grade 3/4 TEAEs was overall similar across subgroups (Table). Summary/Conclusion: Elranatamab is efficacious and has a manageable safety profile in patients with high-risk RRMM and no prior BCMA-directed therapy. Table - R-ISS stage I R-ISS stage II R-ISS stage III Standard cytogenetic risk High cytogenetic risk (n=28) (n=68) (n=19) (n=83) (n=31) Median treatment duration (mo) 10.7 5.7 1.4 7.9 2.6 Receiving treatment at data cut-off (%) 42.9 38.2 5.3 41.0 19.4 ORR (%, 95% CI) 75.0 63.2 26.3 63.9 54.8 (55.1, 89.3) (50.7, 74.6) (9.1, 51.2) (52.6, 74.1) (36.0, 72.7) DOR rate at 12 mo (%, 95% CI) 76.2 78.8 53.3 79.4 57.0 (45.4, 91.0) (61.8, 88.8) (6.8, 86.3) (63.4, 89.0) (27.4, 78.3) Grade 3/4 TEAEs (%) 75.0 73.5 63.2 73.5 64.5 - EMD – N EMD – Y <50% BMPC ≥50% BMPC Penta-refractory disease – N Penta-refractory disease - Y (n=84) (n=39) (n=89) (n=26) (n=71) (n=52) Median treatment duration (mo) 8.4 2.2 8.2 3.0 10.0 2.3 Receiving treatment at data cut-off (%) 38.1 25.6 38.2 26.9 42.3 23.1 ORR (%, 95% CI) 71.4 38.5 67.4 46.2 71.8 46.2 (60.5, 80.8) (23.4, 55.4) (56.7, 77.0) (26.6, 66.6) (59.9, 81.9) (32.2, 60.5) DOR rate at 12 mo (%, 95% CI) 73.8 73.4 72.0 81.5 74.7 71.9 (58.3, 84.3) (37.4, 90.8) (56.6, 82.7) (43.5, 95.1) (58.6, 85.3) (41.2, 88.4) Grade 3/4 TEAEs (%) 77.4 56.4 73.0 69.2 73.2 67.3 Keywords: Myeloma, Bispecific, Multiple myeloma, Clinical trial

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.025
Threshold uncertainty score0.858

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.002
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.009
GPT teacher head0.242
Teacher spread0.233 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations5
Published2023
Admission routes1
Has abstractyes

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