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Attend this session at the
2018 ASCO Annual Meeting!


Session: Hematologic Malignancies—Plasma Cell Dyscrasia

Type: Poster Session

Time: Monday June 4, 8:00 AM to 11:30 AM

Location: Hall A

A phase 3 randomized, controlled, open-label study of selinexor, bortezomib, and dexamethasone (SVd) versus bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (RRMM).

Sub-category:
Multiple Myeloma

Category:
Hematologic Malignancies—Plasma Cell Dyscrasia

Meeting:
2018 ASCO Annual Meeting

Abstract No:
TPS8056

Poster Board Number:
Poster Session (Board #64b)

Citation:
J Clin Oncol 36, 2018 (suppl; abstr TPS8056)

Author(s): Sosana Delimpasi, Ludek Pour, Holger W Auner, Meletios A. Dimopoulos, Alon Rappaport, Lisa Fortin, Jatin J. Shah, Sharon Shacham, Michael G. Kauffman, Nizar J. Bahlis; General Hospital of Athens, Athens, Greece; University Hospital Brno, Brno, Czech Republic; Imperial College London, London, United Kingdom; National and Kapodistrian University of Athens, School of Medicine, Athens, Greece; Karyopharm Therapeutics, Newton, MA; Tom Baker Cancer Centre, Calgary, AB, Canada

Abstract Disclosures

Abstract:

Background: Selinexor is an oral, selective inhibitor of nuclear export that specifically blocks exportin 1, leading to the nuclear accumulation & reactivation of tumor suppressor proteins. Twice weekly (BIW) bortezomib in combination with dexamethasone (Vd) is an established therapy in relapsed and refractory multiple myeloma (RRMM). While the activity of bortezomib (bort) BIW in combination with other agents is efficacious, prolonged use is limited due to peripheral neuropathy (PN) (50-60%) as well as acquired resistance to bort. Preclinical studies have shown that selinexor, when combined with bort, can restore sensitivity of bort-resistant MM, inhibiting tumor growth and increasing survival in murine MM xenografts. In a Ph 1b/2 study, the combination of weekly selinexor with weekly bort and dex (SVd) was well tolerated and highly active with an ORR of 83% in patients (pts) with PI non-refractory MM, furthermore PN was limited to 14%. In addition, in pts with PI refractory MM, an ORR of 43% was observed, supporting selinexor can resensitize myeloma to PI based therapies. Methods: The BOSTON trial (NCT03110562) is a global Ph III study of selinexor in combination with weekly bort and dex (QW SVd) vs BIW bort in combination with dex (BIW Vd), in pts with RRMM who have received 1 to 3 prior anti-MM regimens. The QW regimen of SVd may provide for a higher ORR and improved duration of response as well as provide for a considerable reduction (~40%) in overall bort dose vs BIW Vd arm, which may be associated with better tolerability (e.g., PN) compared with second-line Vd-based regimens. After progressive disease is confirmed by an Independent Review Committee, pts in the Vd arm may crossover to SVd. Crossover to Sd is allowed as compassionate use for pts who are not able to tolerate continued treatment with bort. Progression Free Survival (PFS) and ORR are primary endpoints. Secondary endpoints include overall survival and duration of response. An ORR primary analysis is planned after the last pt randomized has had the opportunity to complete at least 2 MM evaluations. Clinical trial information: NCT03110562

 
Other Abstracts in this Sub-Category:

 

1. Once-weekly vs twice-weekly carfilzomib (K) dosing plus dexamethasone (d) in patients with relapsed and refractory multiple myeloma (RRMM): Results of the randomized phase 3 study A.R.R.O.W.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8000 First Author: Maria-Victoria Mateos
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

2. Pomalidomide (POM), bortezomib, and low‐dose dexamethasone (PVd) vs bortezomib and low-dose dexamethasone (Vd) in lenalidomide (LEN)-exposed patients (pts) with relapsed or refractory multiple myeloma (RRMM): Phase 3 OPTIMISMM trial.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8001 First Author: Paul G. Richardson
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

3. Daratumumab (DARA) in combination with carfilzomib and dexamethasone (D-Kd) in lenalidomide (Len)-refractory patients (Pts) with relapsed multiple myeloma (MM): Subgroup analysis of MMY1001.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8002 First Author: Ajai Chari
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

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