Karyopharm Reports Clinical Data for Selinexor in Advanced Solid Tumors

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Karyopharm Therapeutics Inc.
KPTI
, a clinical-stage pharmaceutical company, announced today the presentation of clinical data from an ongoing Phase 1 clinical study for its lead product candidate, Selinexor (KPT-330), a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound, in patients with advanced solid tumors. Data presented in patients with chemotherapy refractory, castrate-resistant prostate cancer (CRPC) treated with single-agent Selinexor showed a 60% disease control rate with maximum prostate-specific antigen (PSA) reduction ranging from 27% to 60% and duration of treatment up to 502 days. Selinexor also demonstrated early signs of clinical activity in other solid tumor indications including head and neck squamous cell carcinoma and ovarian cancer. Selinexor was shown to have manageable and predictable side effects, primarily nausea, fatigue and anorexia, which improve over time on treatment. These data were presented at the 2014 Congress of the European Society for Medical Oncology (ESMO), occurring September 26-30, 2014 in Madrid, Spain. The company will host a conference call to discuss the ESMO data on Monday, September 29, 2014 at 4:30pm ET. "We continue to be impressed with the performance of Selinexor in advanced solid tumors," stated Dr. Sharon Shacham, PhD, President and CSO of Karyopharm. "In particular, the clinical activity and safety profile demonstrated in patients with chemotherapy refractory, castrate-resistant prostate cancer were very encouraging as these heavily pretreated patients have no other standard treatment options available. The safety and response data reported at ESMO further support our decision to proceed with Phase 2 studies in this difficult-to-treat patient population." In an oral presentation entitled "Selinexor (KPT-330), an Oral, Selective Inhibitor of Nuclear Export (SINE) Shows Anti-Prostate Cancer (PrCa) Activity Preclinically & Disease Control in Patients (pts) with Chemotherapy Refractory, Castrate-Resistant Prostate Cancer (CRPC)", data evaluated as of September 10, 2014, demonstrated that of 15 enrolled patients, nine (60%) achieved stable disease and two (13%) had progressive disease with time to progression ranging from 31 to 502 days on study. Four patients were not evaluable for response.   "These data reveal Selinexor to be generally well-tolerated with manageable side effects and promising PSA decreases in patients with chemotherapy refractory, castrate-resistant prostate cancer," said Christopher J. Logothetis, M.D., Department Chair, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. "Though early, these data support further studies of Selinexor in patients with treatment-resistant prostate cancer." Karyopharm has previously announced the initiation of a Phase 2 single-agent, open-label study of Selinexor in patients with metastatic CRPC. The study, referred to as Selinexor in Hormone Refectory Indications in Prostate Cancer, or SHIP, is expected to evaluate approximately 50 patients with adenocarcinoma of the prostate with evidence for skeletal metastases on bone scan and/or CT scan. Approximately 50 qualifying patients with metastatic CRPC following at least one of the recently approved agents (enzalutamide, abiraterone or radium 223) will receive 50 mg/m^2 of Selinexor orally twice per week over each 28-day cycle. The study is being conducted at the MD Anderson Cancer Center lead by Drs. Christopher Logothetis and John Araujo. The primary goal of the study is to determine the disease control rate assessed according to RECIST criteria and the prevention of new bone lesions. The secondary goal of the study is to evaluate the PSA response relative to baseline.  Additional studies in prostate cancer patients are planned. In addition to data in patients with prostate cancer, Phase 1 study data was also presented that demonstrates the potential of Selinexor as a treatment for other heavily pretreated solid tumor indications, including head and neck squamous cell carcinoma and ovarian cancer. In a poster presentation entitled "Clinical Activity of the Oral Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients with Head & Neck Squamous Cell Carcinoma (HN-SCC)", single-agent Selinexor was shown to stabilize disease progression in 11 (69%) of 16 heavily pre-treated patients with different types of head and neck squamous cell carcinomas. Several patients with thymic epithelial carcinomas showed durable disease shrinkage Based on the favorable safety profile to date and encouraging efficacy data, Karyopharm has initiated a Phase 2 single-agent study of Selinexor in patients with squamous cell carcinomas. The study, referred to as Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas, or STARRS, is expected to evaluate approximately 66 patients with head and neck, lung and esophageal squamous cell carcinomas who have relapsed or have metastasis following chemotherapy.  Eligible patients have received one or two prior therapies and have demonstrated progressive disease upon enrollment. Patients will receive single-agent oral Selinexor dosed twice weekly at 55 mg/m^2. The study will be conducted at approximately 28 sites in the United States and Canada. Disease control rate, defined as stable disease or better, is the primary endpoint. In a second poster presentation entitled "Preclinical and Early Clinical Activity of the Oral Selective Inhibitor of Nuclear Export (SINE) Exportin 1 (XPO1) Antagonist Selinexor (KPT-330) in Patients (pts) with Platinum Resistant/Refractory Ovarian Cancer (OvCa)", Selinexor administered to seven heavily-pretreated patients with ovarian cancer was shown to induce durable disease stabilization or tumor size reduction, including one partial response, in three (60%) of five evaluable patients. Two patients (40%) experienced progressive disease and two patients withdrew consent or were not evaluable. Side effects were generally low grade and typically gastrointestinal in nature, or fatigue. These common side effects decreased over time, in part due to prophylactic use of standard supportive care. Major organ dysfunction or clinically significant cumulative toxicities have not been observed. Karyopharm has previously announced the initiation of a Phase 2 single-agent study of Selinexor in patients with advanced gynecological malignancies. The study, referred to as Selinexor in Gynecology Neoplasms, or SIGN, is expected to evaluate approximately 63 patients with ovarian carcinoma, endometrial carcinoma and cervical carcinoma. Eligible patients have demonstrated progressive disease upon enrollment and have received at least one line of chemotherapy following relapse or, in the case of endometrial or cervical carcinomas, to treat advanced (stage IVb) disease. Patients receive single-agent oral Selinexor dosed twice weekly at 50 mg/m^2. The study is being conducted at approximately four sites in Europe. The primary goal of the study is to determine the disease control rate assessed according to RECIST criteria.
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