Slide 1: Phase 2a Study of SLS009 with Azacitidine and Venetoclax in R/R AML
Phase 2a Study of SLS009, a Highly Selective CDK9 Inhibitor, In Combination with Azacitidine and Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia After Prior Venetoclax Treatment Joshua F. Zeidner, MDa, Omer Jamy, MDb, Bradley W Christensen. MDc Sharif Khan, MDd , Dragan Cicic, MDe, Tapan M
Slide 2: CDK9 as a Target & GFH009 Mechanism of Action
CDK9 as a Target & GFH009 Mechanism of Action • Cyclin-dependent kinase 9 (CDK9) is a transcriptional regulator of multiple oncogenes, including short-lived ones like MCL-1 and c-MYC1,2 – Upregulated in hematologic malignancies and play a role in proliferation and survival of cancerous cells1,2 • CD
Slide 3: GFH009 + Aza/Ven Phase 2a Trial in Ven-R/R AML
GFH009 + Aza/Ven Phase 2a Trial in Ven-R/R AML Study Design Eligibility and Endpoints Venetoclax (Ven) * PO Daily on D1-28 Eligibility Criteria: Weekly D1 D8 D15 D22 SLS009 • >18 years w/ R/R AML after Ven- Dosing Azacitidine (Aza) based regimen 75mg/m2 IV/SQ • ECOG PS = 0-2 • N up to 30 pts • *Ven
Slide 4: Patient Characteristics
Patient Characteristics Characteristic N=30 • 30 patients treated overall • DL1 (45 mg IVQW): n=10 Age: Median (Range), Years 71 (41-84) • DL2 (60 mg IVQW): n=9 >70 years 20 (67%) • DL3 (30 mg IVBIW): n=11 Female 13 (43%) # of prior lines of therapy: Median (Range) 2 (1-4) 2022 ELN Risk Favorable-Ri
Slide 5: Safety and Tolerability
Safety and Tolerability • Across all 3 dose levels, no dose limiting toxicities (DLTs) were observed – No treatment-related mortality and no serious adverse reactions were observed 45 mg QW (N=10) 60 mg QW (N=9) 30 mg BIW (N=11) All patients (N=30) Any grade(%) ≥G3 (%) Any grade(%) ≥G3 (%) Any grade
Slide 6: Efficacy
Efficacy 70% CR CRi MLFS • Among 29 evaluable patients-> 16 (55%) had >50% reduction in 60% BM blasts compared to baseline ORR at each Dose Level 50% • 9 (31%) pts achieved ORR (CR+CRi+MLFS) 40% • 5 (17%) achieved CR/Cri • 8/9 responses occurred 30% w/in 1st cycle 20% • All 9 responders had AML-MR •
Slide 7: Conclusions
Conclusions • Addition of SLS009 to Aza/Ven safe and feasible without DLT’s observed at any dose level in R/R AML patients after prior Venetoclax • RP2D of SLS009 30 mg IV BIW + Aza/Ven in R/R AML • Clinical activity observed with SLS009 + Aza/Ven – Primary endpoint (ORR > 20%) met – AML-MR enriched
Slide 8: Acknowledgements
Acknowledgements We thank all of the patients and families who participated in this study 8