– 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 III SEAL Trial Published in a Peer-Reviewed Medical Journal –
SHANGHAI, China and NEWTON, Mass., – April 27, 2021 – Antengene’s partner, Karyopharm Therapeutics Inc. (Nasdaq:KPTI), recently announced that health-related quality of life (HRQoL) data from the Phase III portion of the trial of selinexor in advanced liposarcoma (the SEAL trial) were published online in Future Oncology. The SEAL trial evaluated single agent selinexor versus matching placebo in patients with advanced unresectable dedifferentiated liposarcoma (DDLPS) who have experienced disease progression following at least two prior therapies. 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.
“The Phase III SEAL trial 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 Kevin Lynch, Chief Medical officer of Antengene. “We are pleased to see the first set of data from the Phase III SEAL trial now published in Future Oncology. 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 III SEAL Trial Health-Related Quality of Life Results
The published SEAL trial results were based on the randomized, double blind, placebo-controlled, cross-over, Phase III portion of the trial, which evaluated oral selinexor versus matching placebo in 285 adult patients with advanced unresectable DDLPS. The secondary endpoint of the SEAL trial measured HRQoL outcomes by using the EORTC QLQ-C30 questionnaire, which was completed by 255 patients in the trial. Overall, the results showed that pain scores worsened in the placebo arm compared to the selinexor arm across all post-baseline visits. 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 is accompanied by clinically important reduction in pain, with minimal effects on other aspects of quality of life.
About the SEAL Trial
SEAL was a Phase II/III, randomized, double blind, placebo-controlled, multicenter trial designed to evaluate the efficacy and safety of twice-weekly, 60mg fixed dose of selinexor in patients with advanced unresectable dedifferentiated liposarcoma following at least two prior therapies. The Phase III portion of the trial enrolled 285 patients (2:1 randomization). Patients on the placebo arm with confirmed progressive disease were permitted to cross over to the selinexor treatment arm. The primary endpoint of the trial was PFS and secondary endpoint measured HRQoL outcomes. In the trial, selinexor was associated with a 30% reduction in the time to disease progression or death in the Phase III portion (hazard ratio (HR)=0.70; p=0.023, medians 2.83 months on selinexor compared to 2.07 months on placebo).
The most common treatment-related adverse events (AEs) were cytopenias, along with gastrointestinal and constitutional symptoms and were consistent with those previously reported from other selinexor studies. Most AEs were manageable with dose modifications and/or standard supportive care. The most common non-hematologic treatment-related AEs were nausea (81%), decreased appetite (60%), fatigue (51%), and vomiting (49%) and were mostly Grade 1 and 2 events. The most common Grade 3 and 4 treatment-related AEs were anemia (19%), hyponatremia (11%), thrombocytopenia (10%) and asthenia (10%).
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases. Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since its establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets through partnerships as well as in-house drug discovery, and obtained 13 investigational new drug (IND) approvals and submitted 5 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene’s vision is to “Treat Patients Beyond Borders”. Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics. For more information, please visit: www.antengene.com.
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