SELLAS Life Sciences to Present Positive Phase 2 Data Demonstrating Encouraging Response and Survival Outcomes with SLS009 Combination in High-Risk AML at ASH 2026
Key Highlights
- ➤Selected-dose monocytic AML achieved 54% ORR and 5.8-month median overall survival
- ➤Selected-dose TP53-mutated AML achieved 57% ORR and 8.8-month median overall survival
- ➤All-dose efficacy reached 34% ORR among 59 evaluable patients
- ➤SLS009 plus azacitidine and venetoclax was well tolerated without meaningful added toxicity
- ➤Frontline AML Phase 2 trial expects early topline data in Q4 2026
Expert Statements
Angelos Stergiou, President and Chief Executive Officer of SELLAS Life Sciences
“There is an urgent need in AML to address the growing number of patients who have either relapsed or become refractory to treatment with venetoclax”
Angelos Stergiou, President and Chief Executive Officer of SELLAS Life Sciences
“Our participation at this year’s ASH Annual Meeting reflects our continued focus on addressing this population by evaluating SLS009 in patients who have failed venetoclax therapy. We look forward to sharing these Phase 2 results with the hematology community and the continued advancement of our SLS009 program, which is currently being studied in newly diagnosed AML patients.”
Angelos Stergiou, President and Chief Executive Officer of SELLAS Life Sciences
“Furthermore, we are excited and hopeful with our galinpepimut-S (GPS) clinical program, as we anticipate reporting the topline primary endpoint data in the Phase 3 REGAL study soon. Overall, we expect to have a strong presence at this year’s ASH meeting as we continue our mission to develop medicines with the potential to advance the standard of care for patients with AML”
Joshua Zeidner, Principal Investigator and Professor of Medicine at University of North Carolina, Lineberger Comprehensive Cancer Center
“AML patients who progress after venetoclax-based therapy have very limited treatment options. Venetoclax resistance is largely driven by MCL-1 dependence”
Joshua Zeidner, Principal Investigator and Professor of Medicine at University of North Carolina, Lineberger Comprehensive Cancer Center
“Furthermore, AML patients with TP53 mutations have poor outcomes with venetoclax-based therapy. The response rates of 57% in relapsed TP53-mutated and 54% in relapsed monocytic AML are encouraging and suggest that SLS009 acts on the biology that drives resistance. Continued investigation of SLS009 in combination with azacitidine and venetoclax in the frontline setting is now a natural development course for this therapy.”
Dragan Cicic, Senior Vice President and Chief Development Officer of SELLAS Life Sciences
“These results show that adding SLS009 can restore responses in this setting, including in TP53-mutated disease, without adding meaningful toxicity, which matters most for patients who have struggled to remain on venetoclax-based treatments due to poor tolerability”
Dragan Cicic, Senior Vice President and Chief Development Officer of SELLAS Life Sciences
“We have now taken SLS009 into the frontline setting, guided by precision medicine. Our extensive biological and multi-omics analyses, including genomics and single-cell profiling, help us identify which patients could benefit most and when to add SLS009 to azacitidine and venetoclax. We expect first topline data from the Phase 2 frontline trial in Q4 2026, and we believe moving SLS009 into earlier lines of treatment will give it the best chance to change the course of this disease.”
− Company to present Phase 2 clinical data evaluating SLS009 (tambiciclib) in combination with azacitidine and venetoclax in patients who have previously failed venetoclax-based therapy −
− Patients with relapsed/refractory monocytic AML achieved a 54% ORR with a median overall survival (mOS) of 5.8 months and patients with TP53-mutated AML achieved a 57% ORR and a mOS of 8.8 months, comparing favorably to historical outcomes in these adverse-risk settings of ~2.5 months −
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