P879: LONG-TERM FOLLOW-UP FROM MAJESTEC-1 OF TECLISTAMAB, A B-CELL MATURATION ANTIGEN (BCMA) X CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM)
Notice bibliographique
Résumé
Topic: 14. Myeloma and other monoclonal gammopathies - Clinical Background: Teclistamab is the first approved off-the-shelf BCMA×CD3 bispecific antibody for the treatment of patients (pts) with RRMM based on data from the pivotal phase 1/2 MajesTEC-1 study (NCT03145181/NCT04557098). Moreau et al (NEJM 2022) reported rapid, deep, and durable responses: overall response rate (ORR) was 63% (39% ≥complete response [CR] rate), with a median duration of response (mDOR) of 18.4 mo, and median progression-free survival (mPFS) of 11.3 mo after a median follow-up (mFU) of 14.1 mo. Aims: To present updated results from the MajesTEC-1 study with extended follow-up of ~2 y (22 mo). Methods: Eligible pts were aged ≥18 y, had documented MM (per IMWG 2016 criteria), and had received ≥3 prior lines of therapy (LOT), including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. Prior BCMA-targeted therapy was not allowed in this cohort. All pts provided informed consent. Pts received teclistamab 1.5 mg/kg QW (the recommended phase 2 dose [RP2D]), with the option to switch to Q2W dosing if they achieved ≥partial response after ≥4 cycles of therapy in phase 1 or ≥CR for ≥6 months in phase 2. The primary endpoint was ORR (assessed per IMWG 2016 criteria by computerized algorithm). AEs were graded per CTCAE v4.03. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded per ASTCT guidelines. Results: As of Dec 9, 2022, 165 pts had received teclistamab at the RP2D (median age, 64 y; 58% male; 26% high-risk cytogenetics; 12% International Staging System stage III). Pts had a median of 5 prior LOT (range, 2–14): 92% daratumumab exposed; 78% triple-class refractory; 81% daratumumab-refractory; and 90% refractory to last LOT. At 22 mo mFU, 43% of pts achieved ≥CR, mDOR was 24 mo (95% CI, 16.2–not estimable [NE]), mDOR in pts achieving ≥CR was not reached (95% CI, 24.0–NE), mPFS was 12.5 mo (95% CI, 8.8–17.2), and median overall survival was 21.9 mo (95% CI, 16.0–NE). Hematologic AEs (any grade [gr]/gr 3/4) included neutropenia (72%/65%), anemia (54%/38%), thrombocytopenia (42%/22%), and lymphopenia (35%/33%). Infections occurred in 78% of pts (52% gr 3/4); key infections included respiratory (56%), COVID-19 (27%), other viral (10%), GI (8%), fungal (5%), PJP (4%), and hepatitis B (0.6%). CRS occurred in 72% of pts (0.6% gr 3; no gr 4/5); 5 (3%) pts reported 9 ICANS events (all gr 1/2; all resolved). 1 pt in phase 1 required a teclistamab dose reduction due to neutropenia. 6 treatment-related deaths have occurred (3 due to COVID-19). Of the 49 pts who remain on study, ~90% have received Q2W dosing. Summary/Conclusion: After ~2 y mFU, pts receiving teclistamab demonstrated deep and durable responses regardless of refractory status, with mPFS of 12.5 mo and mDOR of 24 mo (not reached in those achieving ≥CR). These long-term follow-up data support teclistamab as a safe and effective off-the-shelf BCMA bispecific therapy for pts with RRMM. © 2023 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2023 ASCO Annual Meeting. All rights reserved. Keywords: Bispecific, Multiple myeloma, B-cell maturation antigen, Phase I/II
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».