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
SLS009 combo shows 54% ORR in monocytic AML and 57% ORR in TP53-mutated AML post-venetoclax, mOS 5.8 to 8.8 months vs ~2.5 historical.
What this release says
SELLAS will present Phase 2 data for its SLS009 (tambiciclib) combination with azacitidine and venetoclax in patients with relapsed or refractory AML after venetoclax failure, at the ASH meeting on December 12-15, 2026. The release reports response rates and survival figures for specific high-risk subgroups and says the combination was well-tolerated. For a shareholder, this is a data presentation at a future conference, and the results are reported from a completed study rather than a new trial readout.
Key figures
- Overall response rate, monocytic AML
- 54%
- Median overall survival, monocytic AML
- 5.8 months
- Overall response rate, TP53-mutated AML
- 57%
- Median overall survival, TP53-mutated AML
- 8.8 months
- Historical outcome in these settings
- ~2.5 months
- Patients in the study
- 62
Positive for shareholders
- Subgroup response rates and survival are described as comparing favorably to historical outcomes in these adverse-risk settings.
- The release says the combination showed no meaningful added toxicity.
- The company expects to report topline Phase 3 REGAL data for galinpepimut-S soon.
Negative for shareholders
- Figures come from a small study of 62 heavily pretreated patients, and the subgroup results are not randomized comparisons.
- The overall response rate across all doses was 34%, lower than the subgroup figures highlighted.
- The SLS009 program is still in development and its data are only being presented at a conference.
Written by Quantisnow AI from this release. Not financial advice.
Key terms
- ORR:
- Overall response rate, the share of patients whose cancer shrank or disappeared to a defined degree during treatment.
- Median overall survival:
- The point at which half of the patients in a study are still alive.
- Venetoclax resistance:
- When leukemia cells stop responding to venetoclax, a drug that normally kills them.
- CDK9 inhibitor:
- A drug that blocks an enzyme called CDK9, which cancer cells use to keep producing proteins they need to survive.
FAQ
When will SELLAS present the SLS009 data?
The data will be presented at the 68th American Society of Hematology Annual Meeting in New Orleans, held December 12-15, 2026.
Which patients did the SLS009 combination study include?
It enrolled 62 patients whose AML relapsed or did not respond after venetoclax-based therapy, with a median age of 70.
What did SELLAS say about safety?
The company said the SLS009 combination was well-tolerated with no meaningful added toxicity.
Historical context for SLS
Across the 16 sessions after earlier SLS headlines, the stock closed higher 7 times and lower 9 times, with a median move of 5.6% in either direction. This shows timing only: many things move a stock in a session, and these figures do not show that any headline caused a move.
| Session | Earlier headline | SLS | SPY |
|---|---|---|---|
| Oct 28, 2026 | SELLAS Life Sciences Reaches 80th Event in Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia | -14.7% | +0.3% |
| Sep 25, 2026 | SELLAS Life Sciences Presents Preclinical Data Demonstrating SLS009 Activity in Pancreatic Cancer Models at the 2026 AACR Conference on Pancreatic Cancer | -3.1% | +0.5% |
| Sep 2, 2026 | SELLAS Life Sciences to Present Preclinical Data on SLS009 in Pancreatic Ductal Adenocarcinoma at the 2026 AACR Conference on Pancreatic Cancer | +7.1% | +0.4% |
| Aug 12, 2026 | SELLAS Life Sciences Reports Second Quarter 2026 Financial Results and Provides Corporate Update | +6.5% | +0.3% |
| May 14, 2026 | SELLAS Life Sciences to Participate in Upcoming Investor Conferences | +13.6% | +0.8% |
| May 13, 2026 | SELLAS Life Sciences Reports First Quarter 2026 Financial Results and Provides Corporate Update | +25.1% | +0.6% |
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