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Hospital Pharmacy Europe     Newsletter          

Drug trial to investigate anti-tumour effect on patients with metastatic breast cancer

A drug trial on a patient with metastatic breast cancer selected by a new drug response predictor has been launched.

This month [26 June 2018] Oncology Venture US Inc,  Oncology Venture AB, and Medical Prognosis Institute A/S announced dosing of the first patient in a Phase 2, open-label clinical trial to investigate the anti-tumor effect and tolerability of 2X-121 in patients with metastatic breast cancer selected by a drug response predictor (DRP®) mRNA-driven multiple biomarker named the 2X-121 DRP®.  The drug is being developed by Oncology Venture US Inc.

George Elston, CEO of Oncology Venture US Inc, said the targeted Phase 2 study “will enable us to rapidly evaluate the efficacy of our tankyrase and PARP inhibitor in heavily pre-treated metastatic breast cancer patients, using the 2X-121 DRP® to prospectively select likely responders to this differentiated therapy”.

2X-121 is an orally-available small molecule PARP and tankyrase inhibitor. The clinical trial is designed to enroll 30 metastatic breast cancer patients regardless of hormone receptor, HER2 status and BRCA1 or 2 status, who have relapsed on two or more different prior therapies, and who are identified by the 2X-121 DRP® as highly likely to respond to treatment with 2X-121.

The 2X-121 DRP is a tumor-agnostic – independent of tumor site ­– molecular biomarker based on expression of 414 genes predictive of response to 2X-121. In a study presented at ASCO, the 2X-121 DRP correctly identified responders and non-responders to treatment irrespective of BRCA mutation status.

Although a patient’s BRCA status is used to identify potential responders for treatment with approved PARP inhibitors, other likely responders are excluded. The 2X-121 DRP biomarker is expected to identify those patients who are likely responders, while excluding the likely non-responders.

In this clinical trial, patients will receive oral treatment with 600 mg of 2X-121, as a single agent, in a 21-day cycle. The main point of this study will be its clinical benefit rate. This is defined as complete response, partial response, or stable disease at greater than 24 weeks post-treatment using the RECIST criteria.

The study will also examine progression free survival, duration of response – from first response to progression – and overall survival.