The trial exceeded its target response rate of 20%, with a 44% ORR among AML-MR patients and 50% in M4/M5 subtypes at the 30 mg BIW dose. How significant are these response rates in the context of relapsed/refractory AML treatment?

Median overall survival for patients refractory to venetoclax-based regimens reached 8.8 months, compared to a historical benchmark of 2.4 months. What does this survival improvement suggest about SLS009’s potential durability of response?

Patients with ASXL1 mutations showed a 50% ORR, indicating strong activity in high-risk molecular subgroups. How might these findings influence future patient selection and precision medicine strategies for AML?

SLS009 was combined with venetoclax and azacitidine without increased toxicity or dose-limiting events. How does this combination enhance anti-tumor activity, and could it redefine standard salvage therapy?

The addition of SLS009 was well tolerated with no dose-limiting toxicities. How important is this safety profile when considering broader adoption or moving into first-line therapy?

The FDA has recommended advancing SLS009 into a first-line AML trial for patients unlikely to benefit from standard aza/ven therapy or early non-responders. How could earlier intervention change patient outcomes compared to salvage settings?

SLS009 is described as potentially first and best-in-class with reduced toxicity and increased potency over other CDK9 inhibitors. What differentiates it mechanistically, and how might this translate clinically?

With Phase 3 planning underway and enrollment expected in early 2026, what key endpoints and patient populations will be critical in determining SLS009’s path toward NDA submission and approval?