Trovagene’s Phase-2 trial shows resistance to anti-androgen therapy
Category: #health  By Pankaj Singh  Date: 2019-04-04
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Trovagene’s Phase-2 trial shows resistance to anti-androgen therapy

The patients, who showed an early response (at C1D8) with reduction in PSA levels, were tested positive for AR-V7.

Trovagene, Inc. has reportedly released the initial data from its ongoing Phase 2 study analyzing effects of Onvansertib with Zytiga® (abiraterone acetate)/prednisone in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).

The data presented at the American Association for Cancer Research (AACR) observed clinical activity in patients showing early resistance to Zytiga® as measured by prostate specific antigen (PSA) response when Onvansertib is combined with Zytiga®.

According to the press release by Trovagene Oncology, the initial PSA response was observed when Onvansertib is combined with daily abiraterone in 2 out of 6 patients. Out of those patients, 1 patient achieved the efficacy endpoint to control disease and tumor decreased by 30% in size as per RECIST criteria.

The change was observed in PSA trajectory in the patient as it changed the primary efficacy endpoint from 100% increase (16.05ng/ml to 34.23 ng/ml) in the 60 days prior to study to 8.4% increase during 84 days on study which shows modification of the natural history of early abiraterone resistance.

The patients, who showed an early response (at C1D8) with reduction in PSA levels, were tested positive for AR-V7, an androgen receptor variant (AR-V7) which resists Zytiga when it does not need androgen for tumor growth.

Reportedly, the safety lead-in segment of the trial demonstrated that combination of Zytiga and Onvansertib is safe and well tolerated. No off-target toxicities have been reported in patients treated to-date.

Dr. Mark Erlander, Chief Scientific Officer, Trovagene, noted that the company is encouraged to observe the safe signs of clinical activity to-date and is fascinated by the potential to effectively treat AR-V7 positive patients.

For the record, Trovagene, Inc. takes a precision medicine approach for developing drugs to target cell division (mitosis) to treat solid tumor cancers, lymphomas and leukemias.



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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