Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk

Shambavi Richard, Ajai Chari, Sosana Delimpasi, Maryana Simonova, Ivan Spicka, Ludek Pour, Iryna Kriachok, Meletios A. Dimopoulos, Halyna Pylypenko, Holger W. Auner, Xavier Leleu, Ganna Usenko, Roman Hajek, Reuben Benjamin, Tuphan Kanti Dolai, Dinesh Kumar Sinha, Christopher P. Venner, Mamta Garg, Don Ambrose Stevens, Hang QuachSundar Jagannath, Phillipe Moreau, Moshe Levy, Ashraf Badros, Larry D. Anderson, Nizar J. Bahlis, Thierry Facon, Maria Victoria Mateos, Michele Cavo, Hua Chang, Yosef Landesman, Yi Chai, Melina Arazy, Jatin Shah, Sharon Shacham, Michael G. Kauffman, Sebastian Grosicki, Paul G. Richardson

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

In the phase 3 BOSTON study, patients with multiple myeloma (MM) after 1–3 prior regimens were randomized to once-weekly selinexor (an oral inhibitor of exportin 1 [XPO1]) plus bortezomib-dexamethasone (XVd) or twice-weekly bortezomib-dexamethasone (Vd). Compared with Vd, XVd was associated with significant improvements in median progression-free survival (PFS), overall response rate (ORR), and lower rates of peripheral neuropathy, with trends in overall survival (OS) favoring XVd. In BOSTON, 141 (35.1%) patients had MM with high-risk (presence of del[17p], t[4;14], t[14;16], or ≥4 copies of amp1q21) cytogenetics (XVd, n = 70; Vd, n = 71), and 261 (64.9%) exhibited standard-risk cytogenetics (XVd, n = 125; Vd, n = 136). Among patients with high-risk MM, median PFS was 12.91 months for XVd and 8.61 months for Vd (HR, 0.73 [95% CI, (0.4673, 1.1406)], p = 0.082), and ORRs were 78.6% and 57.7%, respectively (OR 2.68; p = 0.004). In the standard-risk subgroup, median PFS was 16.62 months for XVd and 9.46 months for Vd (HR 0.61; p = 0.004), and ORRs were 75.2% and 64.7%, respectively (OR 1.65; p = 0.033). The safety profiles of XVd and Vd in both subgroups were consistent with the overall population. These data suggest that selinexor can confer benefits to patients with MM regardless of cytogenetic risk. ClinicalTrials.gov identifier: NCT03110562.

Original languageEnglish (US)
Pages (from-to)1120-1130
Number of pages11
JournalAmerican Journal of Hematology
Volume96
Issue number9
DOIs
StatePublished - Sep 1 2021
Externally publishedYes

ASJC Scopus subject areas

  • Hematology

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