NEWTON, Mass., June 24, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), an innovation-driven pharmaceutical company, today announced that the results of the Phase 2b SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study evaluating XPOVIO in patients with relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL) were published online in The Lancet Haematology. The SADAL study evaluated selinexor, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound for the treatment of adult patients with RR DLBCL, not otherwise specified, who have received at least two prior therapies.
“The clinical outcomes for patients with heavily pretreated relapsed or refractory DLBCL are typically very poor, and hence results from the multinational Phase 2b SADAL study are noteworthy,” said Prof Nagesh Kalakonda, University of Liverpool, lead author of the manuscript. “In this population, single-agent oral XPOVIO (selinexor) demonstrated an overall response rate of 28%, including a complete response rate of 12%. Responses were seen in all subgroups regardless of age, gender, prior therapy, DLBCL subtype or prior stem cell transplant therapy. Importantly, patient responses were durable with a median duration of response of 9.3 months (23.0 months for patients who achieved a complete response). Finally, responses were associated with longer survival, underscoring the potential of oral XPO1 inhibition as an oral, non-chemotherapeutic option for patients with RR DLBCL.”
“These positive data further reinforce our strong belief that oral XPOVIO offers patients an important new treatment option, especially considering the patient population studied in SADAL had an expected median survival of less than six months. Furthermore, treatment with XPOVIO demonstrated deep and durable responses with a safety profile qualitatively similar to previous clinical studies with XPOVIO,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “We are proud to see these published clinical results and are excited to now commercialize XPOVIO in our second cancer indication on behalf of the patients and families who are desperately in need of new treatment options.”
The U.S. Food and Drug Administration (FDA) approved XPOVIO on June 22, 2020 for the treatment of adult patients with RR DLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication was approved based on response rate under the FDA’s Accelerated Approval Program, which was developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). A Marketing Authorization Application for selinexor for RR DLBCL is planned for submission to the European Medicines Agency in 2021.