Zenith Epigenetics has commenced a Phase IIb clinical trial of a combination of its ZEN-3694 with Pfizer’s Talzenna (talazoparib) to treat patients with triple-negative breast cancer (TNBC).
A lead compound of the company, ZEN-3694 is being developed for several oncologic indications.
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The trial will assess the safety and efficacy of the combination therapy in people who have locally advanced or metastatic germline wild type BRCA1/2 TNBC.
It will enrol subjects who have previously received a TROP2 antibody-drug conjugate for locally advanced or metastatic disease.
This trial is an expansion of the lately concluded Phase Ib/II trial.
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The Phase Ib/II trial had met the primary efficacy endpoint of clinical benefit rate including objective responses and stable disease.
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By GlobalDataFurthermore, the combination treatment was found to be well tolerated in the trial.
Data from this concluded trial will be presented on 6 June this year.
Zenith Epigenetics president and CEO Donald McCaffery said: “We are very pleased to advance our TNBC programme to Phase IIb and closer to possible registration.
“There is a significant unmet need in this aggressive cancer with few non-cytotoxic therapy options available for the patient”.
Apart from the Phase IIb trial, ZEN-3694 is being analysed along with Xtandi (enzalutamide) in a Phase IIb trial for metastatic castration-resistant prostate cancer.
In addition, a Phase Ib/II trial of ZEN-3694 plus Keytruda (pembrolizumab) and Xtandi for androgen receptor-independent mCRPC and a Phase Ib/II ovarian cancer trial of ZEN-3694 plus nivolumab and ipilimumab are underway.
An inhibitor of poly (ADP-ribose) polymerase (PARP), talazoparib is approved for usage in the US under the brand name Talzenna.
It is intended to treat adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.
