Myelofibrosis Trials: Diverging Narratives on Enrollment, Endpoint Clarity, and Safety Data

Generated by AI AgentEarnings Decrypt
Monday, Aug 11, 2025 11:12 am ET1min read
Aime RobotAime Summary

- Karyopharm completes Phase III SENTRY trial patient screening for JAK-naive myelofibrosis by week's end, a key milestone in advancing selinexor-based therapy.

- Financial challenges persist with October debt maturity, prompting active lender negotiations to secure liquidity while maintaining clinical progress.

- XPOVIO revenue rises 6% to $29.7M in Q2 2025, driven by its differentiated mechanism in multiple myeloma treatment.

- Anticipated March 2026 SENTRY trial data may redefine myelofibrosis standards through selinexor-ruxolitinib combination therapy.

- EC042 trial for endometrial cancer targets mid-2026 results, focusing on prevalent MMR/TP53 tumor subtypes with significant unmet needs.



Positive Clinical Trial Progress:
- Therapeutics anticipates completing patient screening in the Phase III SENTRY trial for patients with JAK-naive myelofibrosis by the end of the week, marking a major milestone.
- This achievement is due to the successful execution of the clinical trial and collaboration with patients and clinical trial sites.

Financial Challenges and Liquidity:
- The company faces financial constraints with a near-term debt maturity in October, impacting its liquidity.
- Karyopharm is actively engaged with lenders and advisers to enhance liquidity and maximize value, with a focus on addressing financial constraints while maintaining focus on clinical trial progress.

Commercial Performance and Revenue:
- XPOVIO net product revenue was $29.7 million in Q2 2025, up 6% from the previous year, with consistent demand in the community setting.
- The growth is attributed to positioning XPOVIO as a flexible therapy with a differentiated mechanism of action in the multiple myeloma market.

Pivotal Phase III Trials and Data Anticipation:
- Karyopharm anticipates top-line data from its SENTRY trial in March 2026, with preliminary blinded safety data suggesting potential improvements in selinexor's tolerability using antiemetics.
- The organization is confident in the potential transformative role of selinexor and ruxolitinib combination therapy in redefining the standard of care for myelofibrosis, based on strong clinical data to date.

Strategic Focus on Endometrial Cancer:
- Initiatives in endometrial cancer are progressing, with enrollment in the export EC042 trial expected to report top-line data in the middle of 2026.
- The focus on patients with both MMR proficient and TP53 wild-type tumors represents a significant opportunity given their prevalence in advanced or recurrent endometrial cancer cases.

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