Overall Survival with Daratumumab, Lenalidomide, and Dexamethasone in Previously Treated Multiple Myeloma (POLLUX) : A Randomized, Open-Label, Phase III Trial
Dimopoulos, Meletios (National and Kapodistrian University of Athens)
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Nahi, Hareth (Department of Medicine. Karolinska University)
San-Miguel, J (Clínica Universidad de Navarra)
Bahlis, Nizar J. (University of Calgary)
Usmani, S. Z (Memorial Sloan Kettering Cancer Center)
Rabin, Neil (Department of Haematology. University College London Hospitals NHS Trust)
Orlowski, Robert Z. (Department of Lymphoma and Myeloma. The University of Texas)
Suzuki, Kenshi (Department of Hematology. Japanese Red Cross Medical Center)
Plesner, Torben (University of Southern Denmark)
Yoon, Sung Soo (Department of Internal Medicine. Seoul National University)
Ben Yehuda, Dina (Hematology Department. Hebrew University)
Richardson, Paul G. (Dana-Farber Cancer Institute (Estats Units d'Amèrica))
Goldschmidt, Hartmut (Heidelberg University Hospital (Alemanya))
Reece, Donna (Department of Medical Oncology and Hematology. Princess Margaret Cancer Centre)
Ahmadi, Tahamtan (Genmab US (Estats Units d'Amèrica))
Qin, Xiang (Janssen Research & Development (Xina))
Garvin Mayo, Wendy (Janssen Research & Development (Estats Units d'Amèrica))
Gai, Xue (Janssen Research & Development (Estats Units d'Amèrica))
Carey, Jodi (Janssen Research & Development (Estats Units d'Amèrica))
Carson, Robin (Janssen Research & Development (Estats Units d'Amèrica))
Moreau, Philippe (Hematology Department. University Hospital Hôtel-Dieu)

Data:	2023
Resum:	PURPOSEWith the initial analysis of POLLUX at a median follow-up of 13. 5 months, daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly prolonged progression-free survival versus lenalidomide and dexamethasone (Rd) alone in patients with relapsed or refractory multiple myeloma (RRMM). We report updated efficacy and safety results at the time of final analysis for overall survival (OS). METHODSPOLLUX was a multicenter, randomized, open-label, phase III study during which eligible patients with ≥ 1 line of prior therapy were randomly assigned 1:1 to D-Rd or Rd until disease progression or unacceptable toxicity. After positive primary analysis and protocol amendment, patients receiving Rd were offered daratumumab monotherapy after disease progression. RESULTSSignificant OS benefit was observed with D-Rd (hazard ratio, 0. 73; 95% CI, 0. 58 to 0. 91; P =. 0044) at a median (range) follow-up of 79. 7 months (0. 0-86. 5). The median OS was 67. 6 months for D-Rd compared with 51. 8 months for Rd. Prespecified analyses demonstrated an improved OS with D-Rd versus Rd in most subgroups, including patients age ≥ 65 years and patients with one, two, or three prior lines of therapy, International Staging System stage III disease, high-risk cytogenetic abnormalities, and refractoriness to their last prior line of therapy or a proteasome inhibitor. The most common (≥ 10%) grade 3/4 treatment-emergent adverse events with D-Rd versus Rd were neutropenia (57. 6% v 41. 6%), anemia (19. 8% v 22. 4%), pneumonia (17. 3% v 11. 0%), thrombocytopenia (15. 5% v 15. 7%), and diarrhea (10. 2% v 3. 9%). CONCLUSIOND-Rd significantly extended OS versus Rd alone in patients with RRMM. To our knowledge, for the first time, our findings, together with the OS benefit observed with daratumumab plus bortezomib and dexamethasone in the phase III CASTOR trial, demonstrate OS improvement with daratumumab-containing regimens in RRMM (ClinicalTrials. gov identifier: NCT02076009 [POLLUX]).
Nota:	Supported by Janssen Research & Development, LLC.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Aged ; Antineoplastic Combined Chemotherapy Protocols ; Dexamethasone ; Disease Progression ; Humans ; Lenalidomide ; Multiple Myeloma
Publicat a:	Journal of Clinical Oncology, Vol. 41 Núm. 8 (october 2023) , p. 1590-1599, ISSN 1527-7755

DOI: 10.1200/JCO.22.00940
PMID: 36599114

13 p, 471.4 KB

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