On January 14, 2016 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clinical-stage pharmaceutical company, reported the initiation of Selinexor in Advanced Liposarcoma ("SEAL"), a new Phase 2/3 clinical trial with oral selinexor, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound that inhibits exportin 1 (XPO1)(Filing, 8-K, Karyopharm, JAN 14, 2016, View Source [SID:1234508821]).
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SEAL is a multi-center, randomized, double-blind, placebo-controlled Phase 2/3 clinical trial evaluating single-agent oral selinexor in patients with advanced unresectable dedifferentiated liposarcoma. Patients will be randomized to receive either 60mg of selinexor or placebo given twice weekly per six week cycle until progression or intolerability. Fifty patients are expected to be enrolled in the Phase 2 portion of the study, with the potential to increase enrollment in the Phase 3 portion following an interim analysis. The primary endpoint of progression free survival (PFS) was acceptable to the Food and Drug Administration (FDA). Top-line data from the Phase 2 portion of this study are expected in early 2017.
"The rationale for SEAL is based on data from a Phase 1b study demonstrating durable stable disease with single-agent selinexor in patients with liposarcoma and other sarcomas," said Mrinal M. Gounder, MD, Attending Physician, Sarcoma Service and Developmental Therapeutics Service, Memorial Sloan Kettering Cancer Center, and Lead Investigator of the SEAL trial. "These data, presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2015 Annual Meeting in June, showed durable responses in liposarcoma, leiomyosarcoma and other sarcomas. Patients with liposarcoma appeared to benefit the most with selinexor, showing an improvement in progression free survival compared to previous chemotherapies." In the Phase 1b study, selinexor showed longer disease control duration compared to the patient’s most recent prior therapy, with 14 of 18 liposarcoma patients (78%) achieving stable disease, including six (43%) of these fourteen patients achieving stable disease for greater than four months.
"With a less-than-5% five-year survival rate for recurrent and high-grade forms of liposarcoma, there are few effective treatment options for these uncommon, difficult to treat tumors that arise from the body’s fat tissue," said Sant P. Chawla MD, Director, Santa Monica Oncology Center, Sarcoma Oncology Center. "Extending progression free survival is an important goal for these patients, in whom the rapid progression of disease frequently translates into early mortality. I look forward to seeing how encouraging early results from selinexor in sarcomas, in which extended disease stabilization was observed, translate to this larger outcome study."
"With our pivotal clinical strategy for selinexor in hematologic malignancies moving toward several key top line readouts, initiation of the SEAL study signals an important expansion of this strategy into solid tumors," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We believe selinexor offers the potential to provide a still deeply underserved liposarcoma patient population with a new therapeutic option. We look forward to the advancement of this study and to the launch of additional randomized studies of selinexor in solid tumors, as well as hematologic malignancies, where high unmet medical needs persist."