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Karyopharm Announces Dosing of First Patients in Two New Company-Sponsored Clinical Studies in Melanoma and Myelofibrosis
NEWTON, Mass., July 28, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"NEWTON, Mass., July 28, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced dosing of the first patients in two new company-sponsored Phase 2 and 1/2 clinical studies evaluating XPOVIO® (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound in combination with approved therapies in patients with advanced melanoma and in patients with treatment naïve myelofibrosis. These company-sponsored studies follow encouraging results from preclinical research and earlier stage, investigator-sponsored clinical studies conducted by Karyopharm's scientific collaborators.\n\"Despite recent advances in treatment options for both metastatic melanoma and myelofibrosis, far too many patients either do not respond or have short-lived responses to currently available treatment options, making the development of novel drug treatment approaches incredibly important for these diseases,\" said Sharon Shacham, PhD, MBA, Chief Scientific Officer of Karyopharm. \"Substantial need remains for continued research into new druggable targets and identifying multiple targets and pathways that have the potential to be inhibited synergistically using combination approaches. We believe XPOVIO's oral administration, along with its novel mechanism of action, make it a promising treatment candidate for new, single and synergistic combination regimens across both hematologic and solid tumors.\"\nSummary of Newly Initiated Clinical Studies: \nA Phase 2 Study Evaluating XPOVIO in Combination with Keytruda® (pembrolizumab) in Recurrent Advanced Melanoma\nThis Phase 2, multicenter, open-label study (XPORT-MEL-033; NCT04768881) will evaluate the safety and efficacy of XPOVIO in combination with Keytruda® and is expected to enroll approximately 40 patients with locally advanced or metastatic melanoma that is resistant to initial checkpoint inhibitor therapy. Patients will receive once-weekly oral XPOVIO (80mg) and Keytruda® (400mg intravenously once every six weeks) until disease progression, toxicity or withdrawal from the study, whichever occurs first. The primary endpoint of the study is overall response rate (ORR). Secondary endpoints include safety, progression-free survival, overall survival (OS), and complete response...