As part of Karyopharm's Phase 1 clinical trial of Selinexor in patients with advanced hematological malignancies, patients with multiple myeloma were treated with either single-agent Selinexor or Selinexor in combination with low-dose dexamethasone. Eight patients with multiple myeloma, whose disease was relapsed and/or refractory to all available classes of approved therapies and progressing on study entry, were treated with 45 mg/m2 of oral Selinexor and 20 mg of dexamethasone, each dosed twice weekly. Patients had received a median of 5.5 prior lines of therapy. All had received prior therapy with a proteasome inhibitor and an immunomodulatory agent, while seven of the eight patients also received stem cell transplantations. Five of the six responding patients remain on study as of
Adverse events in patients receiving single-agent Selinexor were generally low-grade, consistent with events observed in patients with other hematological malignancies and responsive to standard supportive care. Compared with Selinexor given alone, fewer adverse events in patients receiving Selinexor in combination with dexamethasone were reported, consistent with dexamethasone's reduction in Selinexor's main side effects of nausea, anorexia, and fatigue.
"We have observed patients with multiple myeloma receiving durable responses on Selinexor single-agent therapy. We are particularly excited to see that Selinexor with low-dose dexamethasone shows marked activity with rapid M-protein reductions and good tolerability, even in patients with disease refractory to pomalidomide and/or carfilzomib," stated Dr.
In addition to the myeloma data, three presentations on Selinexor in acute myeloid leukemia (AML) will be given at EHA:
- An oral presentation on Sunday, June 15th from 11:15 -
11:30 AM CESTwill focus on the activity of single-agent Selinexor in patients with heavily pretreated AML in the ongoing phase 1 study (Abstract #5591).
- Preclinical data from the combination of Selinexor with the FLT3 inhibitor quizartinib will be reported in a poster presented on Saturday, June 14th from 5:45 -
7:00 PM CEST(Abstract #5575).
- Preclinical data from the
Ohio State Universityproviding evidence that Selinexor restores topoisomerase IIα (Topo IIα) to the nucleus and sensitizes resistant AML blasts to Topo IIα inhibitors including adriamycin will be reported in a poster presented on Saturday, June 14th from 5:45 - 7:00 PM CEST(Abstract #5296).
Clinical and preclinical data on Selinexor in patients with double hit diffuse large B-Cell lymphoma (DLBCL) will be presented in a poster on Friday, June 13th from 5:45 -
An additional poster presentation on Saturday, June 14th from 5:45 -
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with 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. To date, over 300 patients have been treated with Selinexor in Phase 1 and Phase 2 clinical trials in advanced hematologic malignancies and solid tumors. Additional Phase 1 and Phase 2 studies are ongoing or currently planned and three registration-directed clinical trials in hematological indications are expected to begin enrollment during 2014. The latest clinical trial information for Selinexor is available at www.clinicaltrials.gov.
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
Paul Brannellypaul@karyopharm.com 508-975-4820
Source: Karyopharm Therapeutics
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