Karyopharm's Selinexor Plus Ruxolitinib SENTRY Trial Data to be Presented at EHA 2026
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Karyopharm's Phase 3 SENTRY trial evaluating selinexor in combination with ruxolitinib for myelofibrosis has been selected for a late-breaking oral presentation at EHA 2026. This presentation will feature results from the randomized, double-blind, placebo-controlled study.
Karyopharm’s Phase 3 SENTRY trial of selinexor plus ruxolitinib in JAK inhibitor–naïve myelofibrosis was selected for a late-breaking oral presentation at EHA 2026 in Stockholm. The study (NCT04562389) randomizes 353 patients to weekly 60 mg selinexor with ruxolitinib versus placebo plus ruxolitinib and is a key test of XPO1 inhibition in the frontline JAK inhibitor setting.
Contents9 sections
Key Takeaways
- SENTRY (NCT04562389) enrolls 353 JAKi-naïve myelofibrosis patients; 2:1 randomization to selinexor 60 mg weekly plus ruxolitinib.
- Co-primary endpoints: SVR35 at week 24 and average change in Abs-TSS over 24 weeks.
- EHA 2026 late-breaking oral LB5002 was scheduled for 14 June 2026 (presenter: Dr. Claire Harrison).
- Topline: SVR35 co-primary met; Abs-TSS co-primary not statistically different—regulators will weigh both endpoints.
What is the SENTRY trial design for selinexor?
SENTRY is a global, multicenter Phase 3 program comparing selinexor plus ruxolitinib with placebo plus ruxolitinib in JAK inhibitor–naïve myelofibrosis. Patients need platelet counts above 100 × 10⁹/L. The experimental arm uses a fixed starting dose of 60 mg selinexor once weekly with ruxolitinib dosed by baseline platelets.
Full eligibility, arms and endpoints are listed on ClinicalTrials.gov NCT04562389. Karyopharm is the lead sponsor; Menarini/Stemline collaborate on commercial rights outside the United States.
Why did EHA 2026 highlight this selinexor readout?
On 2 June 2026, Karyopharm said EHA’s Scientific Program Committee selected SENTRY as one of six late-breaking oral abstracts. The presentation title is “Selinexor plus ruxolitinib in Janus kinase inhibitor–naïve myelofibrosis: Phase 3 SENTRY trial” (LB5002), timed for Sunday, 14 June 2026, 9:15–10:45 a.m. CEST.
Details appear in Karyopharm’s 2 June 2026 PR Newswire release. Late-breaking status signals high clinical interest but does not change statistical results.
What do the co-primary endpoints mean for myelofibrosis practice?
SVR35 at week 24 is a standard imaging efficacy bar in myelofibrosis registration trials. Abs-TSS tracks patient-reported symptom burden over 24 weeks. Meeting spleen reduction without a statistically significant symptom-score difference creates a nuanced benefit–risk story for payers and regulators.
- Frontline combination versus ruxolitinib monotherapy is more ambitious than a relapsed JAKi-failure niche.
- Safety (cytopenias, gastrointestinal toxicity typical of XPO1 inhibitors) will matter as much as spleen depth.
- Overall survival signals, if presented, need mature follow-up before labeling claims.
Clinicians already choose among JAK inhibitors and add-on strategies when spleen response stalls. A weekly oral XPO1 inhibitor on top of ruxolitinib would compete on depth of spleen response, platelet preservation and real-world tolerability—not on novelty alone. Hematology pharmacy teams will also ask how dose holds for selinexor interact with ruxolitinib titration rules used in community practice.
From a BD perspective, SENTRY is a test of whether Karyopharm can expand beyond multiple myeloma and DLBCL labels into a chronic myeloproliferative indication. Partner Menarini’s EU commercial footprint matters for launch sequencing if filings proceed after the EHA dataset stabilizes.
How should investors read partner communications?
Menarini Group also reported SENTRY data around the EHA oral session via PR Newswire on 14 June 2026, reiterating that SVR35 improved significantly on the combination while Abs-TSS did not separate statistically. Cross-check percentages in the oral slides against the registry protocol before modeling peak sales.
Selinexor is already marketed in other hematologic indications; myelofibrosis would be a franchise expansion, not a first approval, if regulators accept the mixed co-primary profile.
What remains unproven after EHA 2026?
A late-breaking congress talk is not an EMA or FDA decision. Durability of spleen responses beyond week 24, transfusion independence, quality-of-life instruments beyond Abs-TSS, and long-term survival still need peer-reviewed publication. Do not assume EU or U.S. myelofibrosis labels until dossiers are filed and reviewed.
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Frequently Asked Questions
What is the SENTRY trial testing with selinexor?
SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 randomized, double-blind study of once-weekly 60 mg selinexor plus ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor–naïve myelofibrosis patients with platelet counts above 100 × 10⁹/L (N=353).
When was SENTRY presented at EHA 2026?
Karyopharm announced a late-breaking oral presentation (abstract LB5002) during the Late-Breaking Oral Session on Sunday, 14 June 2026, at EHA 2026 in Stockholm (congress dates 11–14 June 2026).
Did SENTRY meet both co-primary endpoints?
Per Karyopharm’s March 2026 topline disclosure echoed in partner communications, SENTRY met the spleen volume reduction ≥35% (SVR35) co-primary at week 24 but did not show a statistically significant difference on absolute total symptom score (Abs-TSS) versus ruxolitinib alone.
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