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KPTI

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- Treatment with Selinexor Demonstrated Several Potential Clinical Advantages Compared to Placebo, Including Reduction in Pain, Longer Time to Marked Clinical Deterioration of Pain and Longer Median Time to Next Treatment -

- First Set of Clinical Data from the Phase 3 SEAL Study Published in a Peer-Reviewed Medical Journal -

NEWTON, Mass., April 19, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that health-related quality of life (HRQoL) data from the Phase 3 portion of the SEAL (Selinexor in Advanced Liposarcoma) study were published online in Future Oncology.  The SEAL study evaluated twice weekly, single agent selinexor, the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, versus matching placebo in patients with advanced unresectable dedifferentiated liposarcoma (DDLPS) who have experienced disease progression following at least two prior therapies. XPOVIO® (selinexor) is currently approved by the U.S. Food & Drug Administration (FDA) for the treatment of relapsed or refractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma; XPOVIO has not been approved for the treatment of DDLPS and, therefore, its safety and efficacy for that patient population have not been established.

"The Phase 3 SEAL study suggests that selinexor has enhanced clinical activity and a manageable safety profile in patients with DDLPS, a very rare and aggressive form of cancer where there are very few treatment options available. In addition to meeting its primary endpoint with a statistically significant improvement in progression-free survival (PFS), treatment with selinexor also resulted in improvements in key quality of life parameters as compared to patients treated with placebo," said Jatin Shah, MD, Chief Medical Officer of Karyopharm. "The results highlight that the reduction in tumor growth, as measured by objective radiographic PFS, is accompanied by clinically important reductions in pain, with minimal effects on other aspects of quality of life. Since pain is one of the most devastating symptoms associated with advanced and progressing DDLPS, the significant reduction in pain, and a delay in the time to definitive deterioration reported by patients in the selinexor arm, combined with the convenience of an orally administered therapy, could represent a meaningful clinical benefit to patients."

"We are pleased to see the first set of data from the Phase 3 SEAL study now published in a peer-reviewed medical journal," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "These data continue to support our overarching development strategy to pursue additional solid tumor indications where we believe selinexor can demonstrate meaningful clinical activity both as a single agent, and more importantly, as part of future combination regimens for patients battling cancer."

The Phase 3 SEAL Study Health-Related Quality of Life Results  

The published SEAL study results were based on the randomized, double blind, placebo-controlled, cross-over, Phase 3 portion of the study, which evaluated oral selinexor versus matching placebo in 285 adult patients with advanced unresectable DDLPS. The secondary endpoint of the SEAL study measured HRQoL outcomes by using the EORTC QLQ-C30 questionnaire, which was completed by 255 patients in the study. Overall, the results showed that pain scores worsened in the placebo arm compared to the selinexor arm across all post-baseline visits, though some visits were not statistically significant. The patients who received twice-weekly selinexor also reported lower rates and slower worsening of pain over time and a longer time to marked clinical deterioration of pain compared to patients treated with placebo. Median time to next treatment was also significantly longer in patients receiving selinexor compared to those receiving placebo. These results indicate that reduction in tumor growth (as measured by objective radiographic PFS) is accompanied by clinically important reduction in pain, with minimal effects on other aspects of quality of life.