Selinexor (KPT-330) in Older Patients With Relapsed AML

Summary

This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.

Timeline

Start

2014-03

Primary completion

2018-01-08

Completion

2018-01-08

Outcome

Missed primary endpoint

registry p = 0.4221; Hazard Ratio (HR) 1.18 (95% CI 0.79 to 1.75) NCT02088541 ↗

release “The Phase 2 SOPRA study evaluating single-agent selinexor in relapsed or refractory AML has not reached statistical significance for overall survival, the primary endpoint” karyopharm.com ↗

release “the SOPRA study did not meet its pre-specified primary endpoint” karyopharm.com ↗

Publications

• Sweet K, Bhatnagar B, Dohner H, Donnellan W, Frankfurt O, Heuser M, Kota V, Liu H, Raffoux E, Roboz GJ, Rollig C, Showel MM, Strickland SA Jr, Vives S, Tang S, Unger TJ, Joshi A, Shen Y, Alvarez MJ, Califano A, Crochiere M, Landesman Y, Kauffman M, Shah J, Shacham S, Savona MR, Montesinos P. A 2:1 randomized, open-label, phase II study of selinexor vs. physician's choice in older patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2021 Dec;62(13):3192-3203. doi: 10.1080/10428194.2021.1950706. Epub 2021 Jul 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cytarabine	Small molecule	20 mg	Subcutaneous
Subject	Selinexor	Other / unclassified	55 mg/m2	Oral
Subject	Selinexor	Other / unclassified	60 mg	Oral
Comparator	Hydroxyurea	Other / unclassified	—	—

Indications