Benzinga | Dec 7, 2020 04:07PM EST

Karyopharm Announces Presentation of New XPOVIO Data in Patients with Acute Myeloid Leukemia at the American Society of Hematology 2020 Annual Meeting

-- In a Randomized Investigator Sponsored Study, XPOVIO in Combination with Standard Induction and Consolidation Chemotherapy Demonstrated Improved Survival in Older, Fit Patients with Acute Myeloid Leukemia -

-- Company to Host Virtual Investor and Analyst Event on Tuesday, December 8th at 1:00 PM ET to Review Highlights from the Data Presented at ASH 2020 --

NEWTON, Mass., Dec. 7, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced an oral presentation highlighting data related to XPOVIO(r) (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, was presented at the American Society of Hematology (ASH) 2020 Annual Meeting taking place virtually December 5-8, 2020. The presentation featured new data from a randomized, investigator-sponsored Phase 2 study evaluating combination chemotherapy with or without XPOVIO in newly diagnosed older adults with acute myeloid leukemia (AML).

"AML is an aggressive form of blood cancer that begins in the bone marrow and is frequently characterized by resistance to currently available therapies, especially in elderly patients," said Timothy S. Pardee, M.D., Ph.D., Associate Professor, Hematology and Oncology, Wake Forest School of Medicine and lead author of the presentation. "The data presented today at ASH 2020, show that XPOVIO in combination with standard induction and consolidation chemotherapy appears highly active in older patients with de novo AML. Despite the small size of the study, XPOVIO in combination was associated with a significant survival improvement and a higher overall response rate than standard chemotherapy alone. In addition, accompanying preclinical work suggests that XPOVIO may increase response to cytarabine, one of the standard chemotherapy drugs used to treat AML, by interfering with nuclear-mitochondrial communication. As novel approaches to treating patients with AML are desperately needed, we look forward to further evaluating this active regimen."

"AML is the most common form of acute leukemia in adults and unfortunately, very little improvement has been made in recent years in terms of improving long-term patient outcomes," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "We are extremely pleased to see such striking results from the combination of XPOVIO and standard chemotherapy in newly diagnosed older patients with AML. We believe the data presented at ASH 2020 may encourage interest from the cancer research community to further evaluate the potential use of XPOVIO as a combination drug partner with other standard treatments in older patients with AML."

New Data from Phase 2 Study of XPOVIO in Combination with Chemotherapy in Older Patients with AML

In this randomized Phase 2 study, researchers evaluated standard intensive chemotherapy (the "7+3" regimen because it consists of cytarabine continuously for seven days, along with short infusions of an anthracycline drug on each of the first three days) with or without XPOVIO in newly diagnosed patients with AML who were 60 years of age or older. Responding patients could go on to receive high dose cytarabine consolidation therapy with or without XPOVIO as per initial randomization. Patients in the XPOVIO arm who completed all consolidation could then move to maintenance therapy with XPOVIO alone. Induction therapy consisted of cytarabine (by continuous infusion for seven days) and daunorubicin (on days 1-3). Consolidation consisted of cytarabine therapy. XPOVIO was dosed orally at 60mg twice weekly during induction and consolidation and once weekly during maintenance.