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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