Trovagene (TROV) Says Onvansertib Trial in KRAS-Mutated Colorectal Cancer Demonstrates Consistent Tumor Regression Across KRAS Mutation Subtypes and Durable Response

Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including colorectal cancer, prostate cancer and leukemia, today announced new positive results from its ongoing Phase 1b/2 clinical trial of onvansertib in combination with FOLFIRI and Avastin® (bevacizumab) for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). The data were featured in a virtual oral presentation, delivered by Dr. Afsaneh Barzi, at the American Association for Cancer Research (AACR) conference on Monday, April 27th, 2020.

There is a significant, unmet medical need to develop a safe and effective second-line treatment option for patients with KRAS-mutated mCRC. Currently available treatments have limited efficacy with only a 4% response rate and a median of 5.5 months PFS. Other compounds currently in clinical development that target KRAS-mutated cancers have shown minimal activity in mCRC.

"We are encouraged by the level of activity that we are observing with the combination of onvansertib and standard-of-care FOLFIRI and bevacizumab in our patients with KRAS-mutated colorectal cancer," said Dr. Afsaneh Barzi, principal investigator, who led the trial as an associate professor of clinical medicine at Keck School of Medicine of USC and medical oncologist at USC Norris Comprehensive Cancer Center. "So far we are observing what we had hoped for in this trial – lack of toxicity and positive signs of efficacy. We remain optimistic because we are observing anti-tumor effects of onvansertib, which could present the opportunity for a new treatment designed to attack KRAS-mutant tumors and act synergistically with standard-of-care chemotherapy."

Highlights of AACR Presentation - Onvansertib in KRAS-Mutated mCRC Trial

• In the Phase 1b dose escalation, the 1st two dose levels (onvansertib 12 mg/m2 and 15 mg/m2) have been cleared for safety; the 3rd dose level (onvansertib 18 mg/m2) is enrolling; the maximum tolerated dose has not been reached to-date
• As of the data cut-off date, clinical response was observed in 7 (88%) of the 8 evaluable patients:
  • 3 patients had partial response (PR), 4 patients had stable disease (SD)
  • 1 patient proceeded to have successful curative surgery
  • Progression-free survival (PFS) is 6.5 months to date, with 6 patients remaining on treatment
• Decreases in plasma KRAS mutation level has been demonstrated to be an early marker for therapeutic response:
  • Onvansertib effectively targets predominant KRAS mutants associated with CRC
  • 7 of the 8 patients had a KRAS mutation detected by ctDNA analysis at baseline (ddPCR and NGS)
  • Changes in KRAS mutant during cycle 1 of treatment were highly predictive of tumor regression:
    • 5 patients had a decrease in KRAS mutant to non-detectable level in cycle 1 (28 days) and subsequent tumor regression at 8 weeks
    • 2 patients had detectable KRAS mutant at end of cycle 1 and showed tumor growth at 8 weeks
• The Phase 2 continuation trial will further assess the safety and efficacy of onvansertib at the recommended Phase 2 dose (RP2D) in combination with FOLFIRI + bevacizumab, as well as the value of KRAS liquid biopsy to predict treatment response

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