Turning the Tide

on Relapsed or Refractory Acute Myeloid Leukemia (AML)

Combining Onvansertib with Standard-of-Care Decitabine to Improve Efficacy and Increase Progression-Free Survival

Relapsed or Refractory AML

The 5-year survival rate is only 25%

Resistance develops to first-line standard-of-care treatment, venetoclax in combination with azacytidine or decitabine, within ~11 months.

Onvansertib + Venetoclax Combination Inhibits Cell Proliferation and Tumor Growth

OCI-AML3 Xenograft Growth

Why onvansertib is a promising new treatment option for relapsed/refractory AML: Improving response and increasing overall survival

In preclinical studies using an AML model resistant to venetoclax, onvansertib in combination with venetoclax inhibited cell proliferation and tumor growth, and showed marked synergy.

Combining Onvansertib with Standard-of-Care Decitabine is Providing a New Treatment Option that is Demonstrating Safety and Efficacy in the Relapsed and Refractory Clinical Setting

Phase 1b/2 multi-center open-label clinical trial NCT03303339

“I am encouraged by the preliminary efficacy and safety/tolerability demonstrated in the dose escalation part 1b of our trial.”

Dr. Amer Zeidan, lead investigator and associate professor of Medicine at the Yale School of Medicine

Complete Response Achieved in Phase 1b Trial Onvansertib + Decitabine Clinical Response
  • At the 4 higher dose levels (27 to 90 mg/m2), CR/CRi was observed in 5 of 16 (31%) patients in the decitabine Arm
  • Median time to achieve CR/CRi was 4 cycles (range 1-7)
  • Durable responses for >7 months
  • 4 of the 6 patients remain on treatment and in remission
    • Duration of CR/CRi is respectively: 1.5 – 7 – 8 and 11.5 months

Onvansertib + Decitabine Clinical Response

Bone Marrow Blast Change from Baseline
(Best Response)

There is a Correlation of Biomarker Positive Patients with Response to Treatment

Target engagement in circulating blasts was observed in a subset of patients and was associated with an increase in response to treatment by decrease in bone marrow blasts and rate of complete response (CR + CRi)

  • 8 (33%) of the 24 evaluable patients showed target engagement (biomarker positive)
  • Among patients with at least 1 bone marrow biopsy (n=17), target engagement was associated with a higher response to treatment:
    • 67% (4 of 6) target engagement patients had a ≥20% decrease in blasts versus 18% in non-target engagement patients
    • Complete Response (CR + CRi) was achieved in 2 target engagement patients but in none of the non-target engagement patients

Phase 2 Data Coming Soon