Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma : Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial
PURPOSE: In the phase II ELOQUENT-3 trial (ClinicalTrials.gov identifier: NCT02654132), elotuzumab combined with pomalidomide/dexamethasone (EPd) significantly improved progression-free survival (PFS) versus pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM) previously treated with lenalidomide and a proteasome inhibitor (PI). Here, we present the final overall survival (OS) results.
METHODS: Patients with RRMM who had received ≥ 2 prior lines of therapy, with disease refractory to last therapy and either refractory or relapsed and refractory to lenalidomide and a PI were randomly assigned (1:1) to receive EPd or Pd. The primary end point was PFS per investigator assessment. ORR and OS were secondary end points planned to be tested hierarchically.
RESULTS: A total of 117 patients were randomly assigned to EPd (n = 60) and Pd (n = 57). Among treated patients (EPd 60, Pd 55), there were 37 (61.7%) deaths in the EPd group and 41 (74.5%) in the Pd group, most commonly because of disease progression (EPd 41.7%, Pd 49.1%). Median (95% CI) OS was significantly improved with EPd (29.8 [22.9 to 45.7] months) versus Pd (17.4 [13.8 to 27.7] months), with a hazard ratio of 0.59 (95% CI, 0.37 to 0.93; P = .0217). OS benefit with EPd was observed in most patient subgroups. The safety profile of EPd was consistent with prior reports with no new safety signals detected.
CONCLUSION: EPd demonstrated a statistically significant improvement in OS versus Pd in patients with RRMM previously treated with lenalidomide and a PI who had disease refractory to last therapy. In this setting, ELOQUENT-3 is the first randomized study of a triplet regimen incorporating a monoclonal antibody and Pd to improve both PFS and OS significantly.
| Errataetall: |
CommentIn: J Clin Oncol. 2023 Mar 20;41(9):1788. - PMID 36626704 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
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| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 41(2023), 3 vom: 20. Jan., Seite 568-578 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Dimopoulos, Meletios A [VerfasserIn] |
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| Links: |
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| Themen: |
1351PE5UGS |
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| Anmerkungen: |
Date Completed 19.01.2023 Date Revised 04.04.2023 published: Print-Electronic ClinicalTrials.gov: NCT02654132 CommentIn: J Clin Oncol. 2023 Mar 20;41(9):1788. - PMID 36626704 Citation Status MEDLINE |
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| doi: |
10.1200/JCO.21.02815 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM344796884 |
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| 041 | |a eng | ||
| 100 | 1 | |a Dimopoulos, Meletios A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma |b Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial |
| 264 | 1 | |c 2023 | |
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| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 19.01.2023 | ||
| 500 | |a Date Revised 04.04.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02654132 | ||
| 500 | |a CommentIn: J Clin Oncol. 2023 Mar 20;41(9):1788. - PMID 36626704 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: In the phase II ELOQUENT-3 trial (ClinicalTrials.gov identifier: NCT02654132), elotuzumab combined with pomalidomide/dexamethasone (EPd) significantly improved progression-free survival (PFS) versus pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM) previously treated with lenalidomide and a proteasome inhibitor (PI). Here, we present the final overall survival (OS) results | ||
| 520 | |a METHODS: Patients with RRMM who had received ≥ 2 prior lines of therapy, with disease refractory to last therapy and either refractory or relapsed and refractory to lenalidomide and a PI were randomly assigned (1:1) to receive EPd or Pd. The primary end point was PFS per investigator assessment. ORR and OS were secondary end points planned to be tested hierarchically | ||
| 520 | |a RESULTS: A total of 117 patients were randomly assigned to EPd (n = 60) and Pd (n = 57). Among treated patients (EPd 60, Pd 55), there were 37 (61.7%) deaths in the EPd group and 41 (74.5%) in the Pd group, most commonly because of disease progression (EPd 41.7%, Pd 49.1%). Median (95% CI) OS was significantly improved with EPd (29.8 [22.9 to 45.7] months) versus Pd (17.4 [13.8 to 27.7] months), with a hazard ratio of 0.59 (95% CI, 0.37 to 0.93; P = .0217). OS benefit with EPd was observed in most patient subgroups. The safety profile of EPd was consistent with prior reports with no new safety signals detected | ||
| 520 | |a CONCLUSION: EPd demonstrated a statistically significant improvement in OS versus Pd in patients with RRMM previously treated with lenalidomide and a PI who had disease refractory to last therapy. In this setting, ELOQUENT-3 is the first randomized study of a triplet regimen incorporating a monoclonal antibody and Pd to improve both PFS and OS significantly | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a pomalidomide |2 NLM | |
| 650 | 7 | |a D2UX06XLB5 |2 NLM | |
| 650 | 7 | |a Lenalidomide |2 NLM | |
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| 650 | 7 | |a elotuzumab |2 NLM | |
| 650 | 7 | |a 1351PE5UGS |2 NLM | |
| 650 | 7 | |a Dexamethasone |2 NLM | |
| 650 | 7 | |a 7S5I7G3JQL |2 NLM | |
| 700 | 1 | |a Dytfeld, Dominik |e verfasserin |4 aut | |
| 700 | 1 | |a Grosicki, Sebastian |e verfasserin |4 aut | |
| 700 | 1 | |a Moreau, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Takezako, Naoki |e verfasserin |4 aut | |
| 700 | 1 | |a Hori, Mitsuo |e verfasserin |4 aut | |
| 700 | 1 | |a Leleu, Xavier |e verfasserin |4 aut | |
| 700 | 1 | |a LeBlanc, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Suzuki, Kenshi |e verfasserin |4 aut | |
| 700 | 1 | |a Raab, Marc S |e verfasserin |4 aut | |
| 700 | 1 | |a Richardson, Paul G |e verfasserin |4 aut | |
| 700 | 1 | |a Popa McKiver, Mihaela |e verfasserin |4 aut | |
| 700 | 1 | |a Jou, Ying-Ming |e verfasserin |4 aut | |
| 700 | 1 | |a Yao, David |e verfasserin |4 aut | |
| 700 | 1 | |a Das, Prianka |e verfasserin |4 aut | |
| 700 | 1 | |a San-Miguel, Jesús |e verfasserin |4 aut | |
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