"We are excited by the activity observed to date with single agent oral selinexor in solid tumors, including the meaningful disease control rates observed in several different heavily pretreated gynecological cancer populations," said
In a poster presented on
|SD > 12
|Ovarian||33||18 (55%)||4 (12%)||14 (42%)||15 (45%)|
|Endometrial||12||8 (67%)||2 (17%)||6 (50%)||4 (33%)|
|Cervical||18||7 (39%)||1 (6%)||6 (33%)||11 (61%)|
|Responses adjusted according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|
|DCR=Disease Control Rate (PR+SD), PR=Partial Response, SD=Stable Disease, PD=Progressive Disease|
- Median PFS were approximately 177 days for endometrial cancers, 84 days for ovarian cancer, and 66 days for cervical cancer. Several patients remain on study for more than 6-11 months without clinically significant cumulative toxicities.
- Most common adverse events, including nausea, anorexia, fatigue and thrombocytopenia, were typically Grades 1 or 2 and attenuated over time and/or responded to supportive care.
- Circulating Tumor Cells (CTCs) were evaluated as a predictive marker for tumor response. CTC were collected at baseline and again following selinexor treatment. Patients with no CTCs at baseline responded better to selinexor treatment with only 8% progressive disease and a median of 118 days on study as compared to patients with CTC, of whom 70% had progressive disease and a median of 47 days on study.
In a poster presented on
- 19 patients receiving escalating doses of selinexor across three schedules were evaluable. Two of three patients with refractory diffuse large B-cell lymphoma (DLBCL) achieved a partial response and eight of 16 patients representing a variety of solid tumors including colorectal, pancreas, squamous cell tongue, non-small cell lung, ovarian and hepatocellular carcinoma achieved stable disease.
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor functions by binding with and 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 900 patients have been treated with selinexor in company- and investigator-sponsored Phase 1 and Phase 2 clinical trials in advanced hematologic malignancies and solid tumors. Karyopharm has initiated three registration-directed clinical trials of selinexor, including one in older patients with acute myeloid leukemia (SOPRA), one in patients with Richter's transformation (SIRRT) and one in patients with diffuse large B-cell lymphoma (SADAL). A single-arm trial of selinexor in patients with multiple myeloma (STORM) that is also intended to be registration-directed was initiated in
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). In addition to single-agent activity against a variety of different human cancers, SINE™ compounds have also shown biological activity in models of cancer, inflammation, autoimmune disease, certain viruses, and wound-healing. Karyopharm was founded by Dr. Sharon Shacham and is located in
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 PAK4 inhibitor, 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
Justin Renz(617) 658-0574 email@example.com Gina Nugent(617) 460-3579 firstname.lastname@example.org
Source: Karyopharm Therapeutics
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