Karyopharm's Liposarcoma Candidate Superior In Phase II Study
Zacks Investment Research | Sep 20, 2017 10:55PM ET
Karyopharm Therapeutics Inc. (NASDAQ:KPTI) announced positive data from a phase II portion of phase II/III SEAL study, demonstrating superiority of its liposarcoma candidate, selinexor, in improving progression free survival (PFS) when compared to a placebo. The company’s oral Selective Inhibitor of Nuclear Export compound is being evaluated in patients with advanced unresectable dedifferentiated liposarcoma who have received prior treatment.
Karyopharm’s shares were up more than 6% on Wednesday. In fact, shares of the company are have risen 18.7% year to date, outperforming the industry ’s gain of 1.5%.
Data from the phase II study demonstrated that selinexor achieved the primary endpoint pf PFS by reducing the risk of progression or death in liposarcoma patients by 40%. In a separate assessment by the World Health Organization (WHO), the candidate prolonged the PFS by 16%. The detailed analysis of the study will be presented at a future medical meeting.
The company has already initiated the phase III portion of the SEAL study where 60mg of selinexor administered to patients until disease progression or intolerability will be compared to a placebo. The FDA-approved PFS is the primary endpoint of the study. Top-line data from this study will be available in 2019.
Liposarcoma is a rare form of cancer, which occurs in the soft tissues of the body, especially fatty tissues. The disease is generally treated with surgery in combination with radiation therapy. Hence, an oral dose medicine is a better option for patients.
However, there are drugs that are administered intravenously for treating advanced liposarcoma patients. These include Johnson & Johnson’s (NYSE:JNJ) Yondelis and Eisai Co., Ltd.’s (OTC:ESALY) Halaven.
Karyopharm is also evaluating selinexor in several mid- and later-phase studies in multiple cancer indications, the most advanced being the phase III study of the candidate in combination with J&J’s Velcade in multiple myeloma patients. Selinexor is also being evaluated in patients with gynecological malignancies.
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