Question · Q4 2025
Yanni Sertsis inquired about any refreshed blinded safety data from the first 61 patients in the CENTURY trial, specifically regarding discontinuation rates or adverse events like nausea, anemia, and thrombocytopenia. He also asked about the general protocol for ruxolitinib dosing in the trial, its alignment with the label, and the strategic utility of the SENTRI-II data for future label expansions in myelofibrosis.
Answer
Reshma Rangwala (CMO) confirmed no updates beyond previously disclosed baseline demographics and TSS for approximately 350 patients, noting a high baseline TSS of 22.5 without fatigue. She stated that the selinexor dose intensity for the first 61 patients was greater than 95%. Reshma Rangwala (CMO) explained that ruxolitinib dose modifications follow local labels (consistent with USPI), with investigators guided to modify ruxolitinib for hematologic toxicities and selinexor for non-hematologic toxicities. Richard Paulson (CEO) described SENTRI-II as an opportunity to expand beyond ruxolitinib, allowing patients to start with selinexor monotherapy and add other JAK inhibitors if needed, aiming to broaden guidelines and establish selinexor's role with multiple JAK inhibitors or as monotherapy.
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