Pomalidomide/Daratumumab/Dexamethasone in Relapsed or Refractory Multiple Myeloma: Final Overall Survival From MM-014.

BACKGROUND

Patients with relapsed or refractory multiple myeloma (RRMM) who have exhausted lenalidomide benefits require improved therapies. The 3-cohort phase 2 MM-014 trial (NCT01946477) explored pomalidomide in early lines of treatment for lenalidomide-exposed RRMM. In cohort B, pomalidomide plus daratumumab and dexamethasone (DPd) showed promising efficacy (median follow-up 28.4 months), as previously reported. Here, we report final overall survival (OS) in cohort B.

METHODS

Patients aged ≥ 18 years were treated in 28-day cycles: pomalidomide 4 mg orally daily from days 1 to 21; daratumumab 16 mg/kg intravenously on days 1, 8, 15, and 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 (cycle ≥ 7); and dexamethasone 40 mg (age ≤ 75 years) or 20 mg (age > 75 years) orally on days 1, 8, 15, and 22. The primary endpoint was ORR. OS and safety were secondary endpoints.

RESULTS

Among 112 patients enrolled, 85 (75.9%) had lenalidomide-refractory disease and 27 (24.1%) had lenalidomide-relapsed disease. At a median follow-up of 41.9 months (range, 0.4-73.1), median OS was 56.7 months (95% confidence interval, 46.5-not reached). Treatment-emergent adverse events related to, and leading to discontinuation of, pomalidomide, dexamethasone, or daratumumab occurred in 7 (6.3%), 9 (8.0%), and 6 (5.4%) patients, respectively.

CONCLUSION

With long-term follow-up, our results show favorable OS with DPd. The safety profile was consistent with previous reports, with no new safety signals identified. IMiD agent-based therapy can still be considered in patients with RRMM who experience progressive disease on or after lenalidomide.

Informations de copyright

Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure N.J.B. declares research funding from Bristol Myers Squibb (BMS); honoraria from AbbVie, Amgen, BMS/Celgene, Forus, Genentech, GlaxoSmithKline (GSK), Janssen, Karyopharm, Pfizer, Sanofi, and Takeda; and payment for expert testimony from BMS/Celgene, Karyopharm, and Pfizer. C.S. declares no competing financial interests. D.R. declares research funding from BMS; consulting fees from Amgen, BMS, and Janssen; honoraria from Amgen, BMS, GSK, Sanofi, and Takeda; payment for expert testimony from BMS and Janssen; and board membership with Canadian Myeloma Research Network (CMRG; Chief Medical Officer). M.S. declares payment for expert testimony from BMS, Gilead/Kite, Janssen, Novartis, Pfizer, and Sanofi; and participation on a data safety monitoring or advisory board with Janssen. J.M. declares consulting fees from BeiGene and Pharmacyclics; and participation on a data safety monitoring or advisory board with BeiGene. J.G.B. declares research funding from 2seventy bio, AbbVie, Acetylon, Amgen, BMS/Celgene, bluebird bio, C4 Therapeutics, CARsgen, Cartesian, Celularity, CRISPR, EMD Serono, Fate, Genentech, GSK, Ichnos, Incyte, Janssen, Karyopharm, Lilly, Novartis, Poseida, Sanofi, Takeda, and Teva; and consulting fees from bluebird bio, BMS/Celgene, CRISPR, Janssen, Kite, Legend, Roche, Secura, and Takeda. J.S. declares honoraria from BMS, Janssen, Pfizer, and Sanofi. G.J.S. declares research funding from AbbVie, Actinium, Actuate, Agios, AltruBio, Amgen, Aptevo, Arog, Astellas, AVM Bio, BioMea, Biopath, Biosight, BMS/Celgene, Celator, Cellectis, Celularity, Cogent, Constellation, Daiichi Sankyo, Deciphera, Delta-Fly, Fate, Forma, FujiFilm, Gamida, Genentech/Roche, Geron, Gilead/Kite, Glycomimetics, Immunogene, Incyte, Janssen, Jazz, Karyopharm, Kiadis, Kronos Bio, Kura, Loxo, Marker, Mateon, Novartis, Onconova, Ono-UK, Orca, Pfizer, PrECOG, Regimmune, Samus, Sangamo, Sellas, Stemline, Syros, Takeda, Tolero, and Trovagene; consulting fees from BMS/Celgene, Curios, and Daiichi Sankyo; honoraria from AbbVie, Agios, Amgen, Astellas, AstraZeneca, AVM Biotech, BMS, Celgene, Gamida, Gilead, GSK, Incyte, Karyopharm, Novartis, Ono, and Stemline; participation on a data safety monitoring or advisory board with Agios, Amgen, AstraZeneca, AVM Biotech, BMS, Gamida, Gilead, GSK, Incyte, Novartis, and Ono; and stock or stock options with Amgen, BMS, and Janssen/Johnson & Johnson. S.G. declares consulting fees from AstraZeneca, BMS, Kite, and Sanofi; and honoraria from Kite and Seagen. K.S. declares research funding from BMS; and honoraria from Amgen, BMS, and Sanofi. C.S.S. declares no competing financial interests. M.A-R. declares honoraria from BMS, Eisai, and Merck Sharp Dohme. M.B. declares no competing financial interests. D.Q. declares no competing financial interests. G.F. declares honoraria from Amgen, BMS, and Sanofi. H.L. declares employment and stock/stock options with BMS. C.G. declares employment and equity ownership with BMS. P.S. declares employment with BMS. D.S. declares research funding from BMS; consulting fees from BMS, Janssen, and Karyopharm; honoraria from BMS and Janssen; participation on a data safety monitoring or advisory board with BMS; and stock or stock options with COTA.