This open-label Phase 2b study will evaluate the safety and efficacy of high dose (100 mg) versus mid dose (60 mg) Selinexor in combination with low dose (8-12 mg) dexamethasone for supportive care, each given orally to approximately 200 patients (100 per arm) with relapsed/refractory DLBCL. Overall response rate (ORR) is the primary endpoint. The study is expected to take approximately two years to complete and is intended to support accelerated regulatory approval. This study was designed in consultation with the
- median duration of response (DOR) of approximately 7 months for Selinexor in patients with
NHL ; - a 40% ORR in aggressive B-cell
NHL , including four of 10 partial responses (PRs), in patients treated with high-dose (≥ 60 mg/m2 equivalent to > 100 mg) Selinexor, and a 37% ORR, including four complete responses (CRs) and three PRs, in patients treated with mid-dose (20-50 mg/m2 equivalent to ~60mg) Selinexor; and - anti-tumor activity across DLBCL subtypes, including 36% and 40% ORRs in patients known to have the Germinal Center B-Cell like (GCB) or non-GCB subtypes, respectively, as well as a 50% ORR (1 CR, 1 PR) in four patients with "double-hit" DLBCL.
"This study in DLBCL is the third registration-directed study initiated for Selinexor this year. In June we initiated a registration-directed study evaluating Selinexor in patients with acute myeloid leukemia and in November we initiated a registration-directed study evaluating Selinexor in patients with Richter's Transformation," said
About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL), accounting for up to 30 percent of newly diagnosed cases in
About Selinexor
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor functions by inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function. This is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. Over 550 patients have been treated with Selinexor in Phase 1 and Phase 2 clinical trials in advanced hematologic malignancies and solid tumors. Karyopharm has initiated three registration-directed clinical trials of Selinexor, one in older patients with acute myeloid leukemia, one in patients with Richter's Transformation and one in patients with diffuse large B-cell lymphoma (DLBCL). At least one additional registration-directed clinical trial in a hematologic or solid tumor indication is also planned for the first half of 2015. Additional Phase 1 and Phase 2 studies are ongoing or currently planned, including multiple investigator-sponsored studies of Selinexor in combination with one or more approved therapies. The latest clinical trial information for Selinexor is available at www.clinicaltrials.gov.
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that any of Karyopharm's SINE™ compounds, including Selinexor (KPT-330), or any other drug candidate that Karyopharm is developing will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm's drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm's drug candidate portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the
CONTACT:Justin Renz (617) 658-0574 jrenz@karyopharm.comGina Nugent (617) 460-3579 nugentcomm@aol.com
Source: Karyopharm Therapeutics
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