November 2022: Prima maturatio bispecifica B-cellula antigenii (BCMA) directa CD3 T-cellula commissarii, teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), probatio accelerata data est a Cibus et medicamentis Administrationis adultis aegris relapsis vel refractoriis multiplicibus. myeloma qui antea quattuor saltem lineas therapiae recepit, cum inhibitore proteasome, medicamento immunomodulatori, et anti-CD38
MajesTEC-1 (NCT03145181; NCT04557098), unum brachium, multi-cohors, aperta pittacium, multi-media iudicium, probatum teclistamab-cqyv. Efficacia hominum comprehenditur ex 110 aegris, qui theraphim BCMA-iactatum antea non receperunt et antea medicamenta saltem tria acceperant, ut proteasome inhibitor, medicamentum immunomodulatorium, anti-CD38 monoclonalis anticorpus.
Super rate responsionis (ORR), sicut aestimata a Review Committee Independente aestimata est utens Criteria Internationalis Myeloma Working Group 2016, tamquam exitus mensurae efficaciae primariae servivit. ORR (95% CI: 52.1, 70.9) erat 61.8%. Extimationis durationis responsionis (DOR) rate erat 90.6% (95% CI: 80.3%, 95.7%) ad 6 menses et 66.5% (95% CI: 38.8%, 83.9%) ad 9 menses inter conventi cum medianis sequentibus. ex 7.4 mensibus.
Monitum de damno neurologico boxed, incluso effectore immunologico cellae neurotoxicitatis associatae, et vita-minatio vel letalis cytokini emissio syndromi (CRS) comprehenditur in praescribens informationes de teclistamab-cqyv (ICANS). Aegris qui indicatam dosem teclistamab-cqyv acceperunt CRS in 72% casuum experti, damnum neurologicum in 57%, et ICANS in 6% casuum. Gradus 3 CRS in 0.6% singulorum occurrit, cum 2.4% aegrorum gradus 3 vel 4 neurologic damnum experti sunt.
Solus modus ad obtinendum teclistamab-cqyv est per arctam rationem currens sub periculo Aestimationis et Mitigationis Strategy (REMS), quae Tecvayli REMS appellatur, ob pericula CRS et toxicity neurologic, inter ICANS.
In 165 aegroti in salute hominum pyrexia, CRS, dolor musculoskeletalis, iniectio situs responsionis, defatigationis, tractus respiratorii superioris, infectio, nausea, capitis, pneumonia, et diarrhoea sicut frequentissimi eventus lateris (20%). Gutta in lymphocytis, diminutio in neutrophilis, diminutio in cellulis sanguineis albis, diminutio in haemoglobin, et diminutio in platelis erant abnormitates laboratorium frequentissimae in Gradibus 3 ad 4 (20%).
Teclistemab-cqyv in cyathis dosibus 0.06 mg/kg ad diem 1, 0.3 mg/kg ad diem 4, 1.5 mg/kg in dies 7, ac deinde 1.5 mg/kg in singulis septimanis usque ad morbum progressum vel toxicitatem intolerabilem.
