Nanobiotix has completed patient enrollment in its Phase 2/3 trial (Act.In.Sarc), which is evaluating the safety and effectiveness of NBTXR3 in soft tissue sarcoma patients. The last patients are expected to initiate treatment in two to three weeks.
“We are pleased to have reached this important milestone in Nanobiotix’s soft tissue sarcoma study, and we look forward to reporting our first data next year,” Elsa Borghi, MD, chief medical officer of Nanobiotix, said in a press release.
NBTXR3 is a nano-sized product, developed to be injected directly into the tumor and enhance radiotherapy effectiveness. The particles, designed to penetrate cancer cells and remain within the tumor, absorb radiation energy upon radiotherapy, and distribute it through the cancer cells.
Currently, NBTXR3 is being developed in the European Union, the U.S., and Asia-Pacific region, for seven cancer indications, including head and neck, prostate, and liver cancers.
The ongoing pivotal Act.In.Sarc trial (NCT02379845) is evaluating the safety and effectiveness of NBTXR3 for the treatment of patients with locally advanced soft tissue sarcoma.
The study is underway in 39 clinical centers in 13 countries worldwide and has enrolled 156 patients. Participants are randomly assigned to receive NBTXR3 plus radiotherapy or radiotherapy alone, prior to surgery.
The trial is evaluating the safety of the treatment, along with effectiveness measures, including changes on tumor volume and objective response rate. Once all patients are treated and concluded through the follow-up period, researchers also will assess if the addition of NBTXR3 can delay tumor progression, compared to radiation therapy and surgery alone. Results are expected by the first half of 2018.
Interim data collected from the first 104 patients of the trial have shown promising safety and effectiveness from the trial. While the data was not disclosed, an Independent Data Monitoring Committee (IDMC) recommended continuation of the study.
Preclinical data suggesting that NBTXR3 also could enhance the effectiveness of immunotherapies has prompted the company to initiate a research program evaluating NBTXR3 as a potential booster for anti-cancer immune responses.
The company recently announced a new U.S.-based Phase 3 trial evaluating NBTXR3 in combination with immune checkpoint inhibitors for the treatment of head and neck, and metastatic lung cancers.