Dreamm-2: single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma (rrmm), including subgroups with renal impairment (ri) and high-risk (hr) cytogenetics
Introduction: Belanatamab mafodotin (GSK2857916; belamaf; BLENREP) showed deep and durable single-agent activity in the pivotal DREAMM-2 study primary analysis (NCT03525678)(1–5) in a patient population that historically has a poor prognosis (overall survival [OS] 6–9 months). This study aims to pre...
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| Format: | Article |
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MDPI AG
2020-09-01
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| Series: | Hematology Reports |
| Online Access: | https://www.pagepress.org/journals/index.php/hr/article/view/8916 |
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| author | S. Lonial H.C. Lee A. Badros S. Trudel A.K. Nooka A. Chari A-O. Abdallah N.S. Callander D.W. Sborov A. Suvannasankha K. Weisel P.M. Voorhees M. Hultcrantz E.N. Libby P.G. Richardson P. Rodriguez Otero B. Besemer T. Facon A. Hoos J. Baron T. Piontek R.C. Jewell E. Lewis J. Opalinska I. Gupta A.D. Cohen A. Medaglia |
| author_facet | S. Lonial H.C. Lee A. Badros S. Trudel A.K. Nooka A. Chari A-O. Abdallah N.S. Callander D.W. Sborov A. Suvannasankha K. Weisel P.M. Voorhees M. Hultcrantz E.N. Libby P.G. Richardson P. Rodriguez Otero B. Besemer T. Facon A. Hoos J. Baron T. Piontek R.C. Jewell E. Lewis J. Opalinska I. Gupta A.D. Cohen A. Medaglia |
| author_sort | S. Lonial |
| collection | DOAJ |
| description | Introduction: Belanatamab mafodotin (GSK2857916; belamaf; BLENREP) showed deep and durable single-agent activity in the pivotal DREAMM-2 study primary analysis (NCT03525678)(1–5) in a patient population that historically has a poor prognosis (overall survival [OS] 6–9 months). This study aims to present longer-term efficacy/safety outcomes (13-month follow-up) with single-agent belamaf in DREAMM-2 in the overall patient population and patients with HR cytogenetics and RI, subgroups with poor outcomes. Methods: DREAMM-2 is an ongoing study of belamaf 2.5 mg/kg (n=97) or 3.4 mg/kg (n=99). Primary outcome: overall response rate (ORR; ≥partial response). In post-hoc analyses, HR-cytogenetics included t(4;14), t(14;16), 17p13del, or 1q21+. RI was based on estimated glomerular filtration rate (mild: ≥60–<90 mL/min/1.73 m[2]; moderate: ≥30–<60 mL/min/1.73 m[2]). Results: Overall population ORRs in the 2.5-mg/kg and 3.4-mg/kg groups were 32% (97.5% CI: 21.7–43.6) and 35% (97.5% CI: 24.8–47.0); 19% and 23% of patients (58% and 66% of responders) achieved very good partial response or better. Median duration of response was 11.0 (95% CI: 4.2–not reached [NR]) and 6.2 months (95% CI: 4.8–NR). Median progression-free survival was 2.8 (95% CI: 1.6–3.6) and 3.9 months (95% CI: 2.0–5.8); median estimated OS was 13.7 (95% CI: 9.9–NR) and 13.8 months (95% CI: 10.0–NR). Most common Grade ≥3 adverse events (AEs) were keratopathy (microcyst-like epithelial changes [MECs] observed on eye examination; 2.5 mg/kg: 46%; 3.4 mg/kg: 42%), thrombocytopenia (2.5 mg/kg: 22%; 3.4 mg/kg: 32%), and anaemia (2.5 mg/kg: 21%; 3.4 mg/kg: 27%). AE-related permanent discontinuation occurred in 9% and 12%; discontinuation due to MECs was rare (2.5 mg/kg: 1%; 3.4 mg/kg: 3%). HR cytogenetics and RI subgroup analyses will be presented at the conference. Conclusions: Deep and durable responses to single-agent belamaf were sustained and no new safety signals identified with longer follow-up in this heavily pretreated RRMM population. Funding: GSK (205678). Drug linker technology licensed from Seattle Genetics; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa. Encore Statement: ©2020 Society of Hematologic Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2020 SOHO Annual Meeting. All rights reserved. 1. Lonial et al. Lancet Oncol. 2020; 2. Lonial et al. ASCO 2020. EP436; 3. Cohen et al. ASCO 2020. EP441; 4. Trudel et al. EHA 2020. EP1037; 5. Lee et al. ASCO 2020. EP419 |
| first_indexed | 2024-04-10T18:07:28Z |
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| id | doaj.art-b45ece96c95e4ce6b6696bd426b34a81 |
| institution | Directory Open Access Journal |
| issn | 2038-8322 2038-8330 |
| language | English |
| last_indexed | 2024-04-10T18:07:28Z |
| publishDate | 2020-09-01 |
| publisher | MDPI AG |
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| series | Hematology Reports |
| spelling | doaj.art-b45ece96c95e4ce6b6696bd426b34a812023-02-02T12:30:55ZengMDPI AGHematology Reports2038-83222038-83302020-09-0112s1Dreamm-2: single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma (rrmm), including subgroups with renal impairment (ri) and high-risk (hr) cytogeneticsS. Lonial0H.C. Lee1A. Badros2S. Trudel3A.K. Nooka4A. Chari5A-O. Abdallah6N.S. Callander7D.W. Sborov8A. Suvannasankha9K. Weisel10P.M. Voorhees11M. Hultcrantz12E.N. Libby13P.G. Richardson14P. Rodriguez Otero 15B. Besemer16T. Facon17A. Hoos18J. Baron19T. Piontek20R.C. Jewell21E. Lewis22J. Opalinska23I. Gupta24A.D. Cohen25A. Medaglia26Emory University, Winship Cancer InstituteMD Anderson Cancer CenterUniversity of Maryland at BaltimorePrincess Margaret Cancer CentreEmory University, Winship Cancer Institute, (2) MD Anderson Cancer CenterIcahn School of Medicine at Mount SinaiUniversity of Kansas Cancer CenterUniversity of Wisconsin, Carbone Cancer CenterHuntsman Cancer Institute, University of UtahIndiana University Cancer CenterMedical Center of Hamburg-EppendorfLevine Cancer Institute, Atrium HealthMemorial Sloan Kettering Cancer CenterDivision of Medical Oncology, University of WashingtonDana-Farber Cancer InstituteClinica Universidad de Navarra-PamplonaUniversitaetsklinikum TuebingenCHRU de Lille, Hopital Claude HuriezGlaxoSmithKline (Philadelphia)GlaxoSmithKline (Philadelphia)GlaxoSmithKline (Philadelphia)GlaxoSmithKline (Research Triangle Park)GlaxoSmithKline (Research Triangle Park)GlaxoSmithKline (Philadelphia)GlaxoSmithKline (Philadelphia)) Abramson Cancer CenterFishawack CommunicationsIntroduction: Belanatamab mafodotin (GSK2857916; belamaf; BLENREP) showed deep and durable single-agent activity in the pivotal DREAMM-2 study primary analysis (NCT03525678)(1–5) in a patient population that historically has a poor prognosis (overall survival [OS] 6–9 months). This study aims to present longer-term efficacy/safety outcomes (13-month follow-up) with single-agent belamaf in DREAMM-2 in the overall patient population and patients with HR cytogenetics and RI, subgroups with poor outcomes. Methods: DREAMM-2 is an ongoing study of belamaf 2.5 mg/kg (n=97) or 3.4 mg/kg (n=99). Primary outcome: overall response rate (ORR; ≥partial response). In post-hoc analyses, HR-cytogenetics included t(4;14), t(14;16), 17p13del, or 1q21+. RI was based on estimated glomerular filtration rate (mild: ≥60–<90 mL/min/1.73 m[2]; moderate: ≥30–<60 mL/min/1.73 m[2]). Results: Overall population ORRs in the 2.5-mg/kg and 3.4-mg/kg groups were 32% (97.5% CI: 21.7–43.6) and 35% (97.5% CI: 24.8–47.0); 19% and 23% of patients (58% and 66% of responders) achieved very good partial response or better. Median duration of response was 11.0 (95% CI: 4.2–not reached [NR]) and 6.2 months (95% CI: 4.8–NR). Median progression-free survival was 2.8 (95% CI: 1.6–3.6) and 3.9 months (95% CI: 2.0–5.8); median estimated OS was 13.7 (95% CI: 9.9–NR) and 13.8 months (95% CI: 10.0–NR). Most common Grade ≥3 adverse events (AEs) were keratopathy (microcyst-like epithelial changes [MECs] observed on eye examination; 2.5 mg/kg: 46%; 3.4 mg/kg: 42%), thrombocytopenia (2.5 mg/kg: 22%; 3.4 mg/kg: 32%), and anaemia (2.5 mg/kg: 21%; 3.4 mg/kg: 27%). AE-related permanent discontinuation occurred in 9% and 12%; discontinuation due to MECs was rare (2.5 mg/kg: 1%; 3.4 mg/kg: 3%). HR cytogenetics and RI subgroup analyses will be presented at the conference. Conclusions: Deep and durable responses to single-agent belamaf were sustained and no new safety signals identified with longer follow-up in this heavily pretreated RRMM population. Funding: GSK (205678). Drug linker technology licensed from Seattle Genetics; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa. Encore Statement: ©2020 Society of Hematologic Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2020 SOHO Annual Meeting. All rights reserved. 1. Lonial et al. Lancet Oncol. 2020; 2. Lonial et al. ASCO 2020. EP436; 3. Cohen et al. ASCO 2020. EP441; 4. Trudel et al. EHA 2020. EP1037; 5. Lee et al. ASCO 2020. EP419https://www.pagepress.org/journals/index.php/hr/article/view/8916 |
| spellingShingle | S. Lonial H.C. Lee A. Badros S. Trudel A.K. Nooka A. Chari A-O. Abdallah N.S. Callander D.W. Sborov A. Suvannasankha K. Weisel P.M. Voorhees M. Hultcrantz E.N. Libby P.G. Richardson P. Rodriguez Otero B. Besemer T. Facon A. Hoos J. Baron T. Piontek R.C. Jewell E. Lewis J. Opalinska I. Gupta A.D. Cohen A. Medaglia Dreamm-2: single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma (rrmm), including subgroups with renal impairment (ri) and high-risk (hr) cytogenetics Hematology Reports |
| title | Dreamm-2: single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma (rrmm), including subgroups with renal impairment (ri) and high-risk (hr) cytogenetics |
| title_full | Dreamm-2: single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma (rrmm), including subgroups with renal impairment (ri) and high-risk (hr) cytogenetics |
| title_fullStr | Dreamm-2: single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma (rrmm), including subgroups with renal impairment (ri) and high-risk (hr) cytogenetics |
| title_full_unstemmed | Dreamm-2: single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma (rrmm), including subgroups with renal impairment (ri) and high-risk (hr) cytogenetics |
| title_short | Dreamm-2: single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma (rrmm), including subgroups with renal impairment (ri) and high-risk (hr) cytogenetics |
| title_sort | dreamm 2 single agent belantamab mafodotin in patients with relapsed refractory multiple myeloma rrmm including subgroups with renal impairment ri and high risk hr cytogenetics |
| url | https://www.pagepress.org/journals/index.php/hr/article/view/8916 |
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