Breaking News: Trovagene Reports New Data from Phase 1b/2 Study of Onvansertib Demonstrates Response to Treatment in Relapsed/Refractory AML

– Preliminary Anti-Leukemic Activity Demonstrates >80% Response to Treatment with Onvansertib in Combination with Low-Dose Cytarabine (LDAC) or Decitabine in Dose Escalation Phase 1b of Trial

– Onvansertib is Safe and Well-Tolerated with No Drug-Related Severe Adverse Events Reported to-date

Trovagene, Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics company, taking a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, today presented updated data from its ongoing Phase 1b/2 study evaluating Onvansertib in combination with standard-of-care chemotherapy in Acute Myeloid Leukemia (AML).

The data, featured in a poster presentation at the 60th American Society of Hematology (ASH) Annual Meeting, demonstrate that Onvansertib, in combination with LDAC or decitabine, even at the dose-escalation phase of the trial, is benefiting patients who have relapsed/refractory Acute Myeloid Leukemia (AML), and that the combination regimen is safe and well-tolerated, with no serious adverse events (SAEs) reported to-date. Onvansertib is a first-in-class, 3rd generation, highly-selective oral Polo-like Kinase 1 (PLK1) Inhibitor that is being evaluated in an ongoing Phase 1b/2 clinical trial at nine sites in the U.S.

AML is a rapidly progressing bone marrow cancer with poor survival rates compared to other leukemias. The standard of care for people with AML is intensive chemotherapy; however, for many elderly patients with AML intensive treatment is not an option. Additionally, patients with relapsed or refractory AML remain among the most challenging to treat and prognosis is poor.

“AML patients with relapsed/refractory disease have very limited, if any, treatment options,” said Dr. Amer Zeidan, lead investigator and assistant professor of Medicine at Yale School of Medicine, and Hematology expert at Yale Cancer Center. “While we are still early in the trial where patients are being treated in the dose escalation phase, we are encouraged by the safety profile of onvansertib. Importantly, there are signs of preliminary efficacy we are already seeing in the dose escalation phase of the trial of onvansertib in combination with decitabine or low dose cytarabine. One patient has achieved an ongoing partial response; showing a significant reduction in blast count and hematologic count improvement, while 9 patients so far have stable disease. AML, especially when relapsed or refractory, is a biologically aggressive cancer, so prolonged periods of stable disease are considered clinically meaningful. We anticipate as we continue in the trial and reach the recommended Phase 2 dose that we will see additional evidence of clinical efficacy.”  

“A key component of our Onvansertib clinical development program is the integration of a predicative biomarker strategy to help identify patients who are more likely to respond to treatment,” said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. “Thus far we have observed a rapid and durable inhibition of the PLK1 enzyme by Onvansertib in a subset of patients, which is also associated with a higher response to treatment, as measured by decreases in circulating and bone marrow leukemic blast cells. We believe this will provide a significant advantage as we advance our clinical trial in AML, and other cancers, and will enable us to select sub-populations of patients who will benefit most from treatment with Onvansertib.”

Presentation Highlights:


  • Polo-like Kinase 1 (PLK1):
  • Onvansertib (also known as PCM-075 and NMS-1286937):


  • No trial therapy-related deaths
  • No Severe Adverse Events (SAEs) were considered related to study drug treatment
  • AE possibly related to Onvansertib was Grade 1 nausea in 4 patients

Preliminary Efficacy

  • Of the 19 patients evaluable for safety, 12 patients had an evaluable bone marrow biopsy to assess anti-leukemic activity based on criteria from the 2017 ELN recommendations
  • Of the 12 patients evaluated for preliminary anti-leukemic activity, 1 patient had a partial response (PR), 9 patients had stable disease (SD) and 2 patients had progressive disease (PD)

Conclusions and Perspective

  • Two dose-levels of Onvansertib (12 mg/m2 and 18 mg/m2) were completed, with 13 patients evaluable for safety
  • 6 patients have been enrolled at the 27 mg/m2 dose-level, 3 have finished cycle 1 without experiencing dose-limiting toxicities (DLTs); 3 patients are on cycle 1 of treatment
  • Preliminary efficacy in the evaluable population showed over 80% patient benefit (CR + PR + SD): 1 patient with PR, 9 patients with SD
  • PLK1 inhibition by treatment was observed in 5 out of 15 patients and was associated with a higher response to treatment, measured by decreases in circulating and bone marrow blasts
  • Implementation of a pTCTP biomarker strategy going forward will increase the opportunity to identify patients most likely to respond to Onvansertib
  • No drug-related deaths or SAEs have been reported to-date

Details of the poster presentation are provided below:

Title:  Phase 1b Safety, Preliminary Anti-Leukemic Activity and Biomarker Analyses of the Polo-like Kinase 1 (PLK1) Inhibitor, Onvansertib, in Combination with Low-Dose Cytarabine (LDAC) or Decitabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia

Session Name:  Session 616. Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: Poster III

Location:  Hall GH (San Diego Convention Center)

Date and Time:  Monday, December 3, 2018; 6:00 PM – 8:00 PM

About the Ongoing Onvansertib Phase 1b/2 Acute Myeloid Leukemia Trial

The Phase 1b/2 trial (NCT03303339) is a multi-center, open-label trial to evaluate the safety and efficacy of Onvansertib in combination with standard-of-care chemotherapy in AML patients who are ineligible for intensive induction therapy or whose disease is relapsed or refractory. In Phase 1b dose-escalation segment of the trial, the primary objective is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), using a traditional 3+3 design. In Phase 2 the MTD or RP2D will be administered to 32 patients to evaluate preliminary antitumor activity and to continue to evaluate the safety and tolerability of Onvansertib in combination with standard-of-care chemotherapy. This trial is being led by Jorge Cortes, M.D., Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and Amer Zeidan, MBBS, MHS, assistant professor of Medicine at Yale School of Medicine, and Hematology expert at Yale Cancer Center. The trial is being conducted at nine sites in the U.S.

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1 Comment
  1. Nancy Gondo 6 months ago

    The treatment’s response rate is impressive. The cancer treatment market is huge but is Onvansertib affordable for patients?

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