Acute myeloid leukemia
SLSSELLAS Life Sciences GroupCatalyst overview
Research summary
This catalyst tracks a Phase 2 data readout for SLS009 (GFH009) +/- venetoclax & azacitidine in Acute myeloid leukemia. The expected timing is based on the latest available company guidance and may change.
4/8/25- OS data from Cohort 3. 5/15/25- First pediatric AML patient dosed. 7/15/25- Met all primary endpoints in Ph2 trial. FDA endorsed progression to Front Line trial & patient enrollment planned for Q1 2026. 11/3/25- Present data at ASH'25 on December 7, 2025. 11/12/25:- Ongoing Ph2 r/r AML trial data accepted for ASH 2025; 80-patient frontline and early-refractory AML study enrollment expected in Q1 2026. 12/07/25:- ASH 2025 Ph2 SLS009+AZA/VEN AML-MR study data showed 46% ORR; study expansion into high-risk newly diagnosed AML planned Q1 2026. 01/14/26:- IMPACT-AML collaboration; frontline high-risk AML AZA/VEN trial enrollment US Q1 2026, Europe Q2 2026. 03/12/26:- First patient enrolled in Ph2 NCT04588922 frontline AML study; topline data expected Q4 2026. 03/17/26:- Preclinical SLS009 AML poster at AACR on April 21, 2026. 03/19/26:- Reiterated Ph2 r/r AML ASH data and expansion into 80-patient frontline AML trial; Europe enrollment Q2 2026. 05/12/26:- Ongoing dosing in 80-patient frontline AML Ph2 NCT04588922; topline still expected Q4 2026; AACR preclinical data. 08/11/26:- NCT04588922 enrolled 28 patients. Dosing continues. Topline data remains expected Q4 2026.
Verification
Confirm timing and program details against the company announcement or filing.