FDA OKs Use of Tool to Predict Patient Response to New Form of Cisplatin in Planned Phase 3 Study

FDA OKs Use of Tool to Predict Patient Response to New Form of Cisplatin in Planned Phase 3 Study

The U.S. Food and Drug Administration (FDA) has approved use of a device, called LiPlaCis DRP, that works to predict response to the next-generation investigational chemotherapy LiPlaCis in a planned Phase 3 clinical trial in people with metastatic breast cancer, Oncology Venture, the company developing both, reports.

The FDA is also evaluating the company’s request to use LiPlaCis in the pivotal trial, a necessary step in starting the study. Dialogue between Oncology Venture and the FDA is ongoing.

LiPlaCis is primarily being developed as a potential treatment for people with metastatic breast cancer who failed to respond to previous lines of therapy. It is an encapsulated formulation of the chemotherapy cisplatin, designed to enable direct delivery to the tumor. The current formulation of cisplatin, Platinol, is effective in about 10% of patients and shows significant toxicity.

LiPlaCis DRP (DRP stands for drug response predictor) is a device that includes 205 genes, and works to select patients whose cancer genetics indicate a high likelihood of responding to LiPlaCis. Determination is based on the patients’ messenger RNA —  produced from DNA in gene expression — that is collected in a pre-treatment biopsy. The device builds on a comparison of sensitive and resistant human cancer cell lines, while incorporating information about tumor biology and known clinical outcomes.

“The FDA approval to use Oncology Venture’s drug response prediction technology, DRP, in a pivotal Phase 3 study of LiPlaCis in the US is a major step forward in establishing our unique concept of precision medicine,” Peter Buhl Jensen, MD, Oncology Venture’s CEO, said in a press release.

LiPlaCis and the DRP tool are currently being evaluated in an ongoing Phase 2 trial (NCT01861496) in people with metastatic breast cancer, prostate cancer, and skin cancer. Early trial data  support both the treatment and the device, finding 70% of the breast cancer patients responding to the targeted chemotherapy and a 100% response rate among those patients identified as responders by the DRP companion tool.

A data update, released in September 2018, showed that five of the nine patients (55%) — all with heavily pre-treated breast cancer — who were predicted to have the highest likelihood of responding to LiPlaCis achieved partial remission.

The DRP platform can be used in all cancer types and is patented to be a companion tool to more than 70 anti-cancer therapies in the U.S., Oncology Venture states.