Trovagene, Inc. TROV announced successful completion of a phase Ib dose escalation study evaluating its sole pipeline candidate, onvansertib, in combination with standard-of-care chemotherapy for treating acute myeloid leukemia (“AML”). The company also announced that it has initiated enrolment in the phase II portion for the candidate in a similar indication.
The phase Ib study evaluated onvansertib+chemotherapy in treatment-naive patients who are ineligible for induction therapy or whose disease has relapsed following prior treatment. The study identified the recommended phase II dose of onvansertib. Data from the dose escalation phase Ib showed that onvansertib in combination with decitabine met the study’s primary endpoint of objective response rate in five out of 21 patients with difficult-to-treat relapsed/refractory AML. Moreover, 30% of the patients in the study were biomarker positive. Data also showed onvansertib plus chemotherapy was safe and well tolerated in patients. Detailed data from the study will be presented at the European Society for Medical Oncology on Sep 28.
The phase II study will evaluate a combination of onvansertib and decitabine in previously not treated patients who are not eligible for induction therapy or in patients whose disease has relapsed following up to one prior regimen.
So far this year, Trovagene’s shares have declined 47.3% compared with the industry’s decrease of 1.4%.
Apart from AML, the company is also developing onvansertib in combination with other drugs for treating metastatic castration-resistant prostate cancer (mCRPC), metastatic colorectal cancer (mCRC) among others.
A phase II study is evaluating onvansertib in combination with J&J’s JNJ Zytiga or prednisone in patients with mCRPC. Another phase Ib/II study is evaluating onvansertib in combination with Sanofi’s SNY Zaltrap (Folfiri) and Roche’s RHHBY Avastin as a second-line treatment for mCRC with a KRAS mutation. The company also has plans to develop onvansertib in combaintion with AbbVie’s Venclexta for first-line AML.
In May, Trovagene signed a research collaboration agreement with Nektar Therapeutics to evaluate a combination of onvansertib and Nketar’s Onzeald BRAF and KRAS mutant colorectal cancer.
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