New Combination Treatment Shows Encouraging Developments For Triple Negative Breast Cancer Patients
Approximately 12% of breast cancers diagnosed in the US are triple negative, according to the American Cancer Society. Recently, Roche, the giant Swiss drugmaker, stated that their trial called IMpassion130 has shown that its immunotherapy Tecentriq in combination with the chemotherapy Abraxane is significantly reducing the risk of disease worsening or death in people with metastatic triple negative breast cancer.
Roche has confirmed that they have also recorded an encouraging overall survival benefit for the PD-L1 positive population, whose tumors express a protein that helps them evade immune system detection, at the interim analysis.
Roche Chief Medical Officer Sandra Horning stated, “Highly encouraged by these results, we plan to submit to health authorities globally with the aim of bringing this combination to people with triple negative breast cancer as soon as possible.”
Another company working on innovations for the treatment of breast cancer is Seattle based Atossa Genetics (NasdaqCM: ATOS). Recently, Atossa announced that it has opened its Phase 2 study of proprietary topical Endoxifen on mammographic breast density, or MBD, reduction. Studies by others have shown that a reduction in MBD reduces the risk of developing breast cancer and may potentially improve the accuracy of mammography in finding cancer.
The Phase 2 study is being conducted at Stockholm South General Hospital in Sweden and is being led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.
“Opening our first Phase 2 study using our proprietary topical Endoxifen marks a major milestone in our clinical development,” commented Steve Quay, Ph.D., MD, President and CEO of Atossa. “We look forward to working with Dr. Hall and his clinic to enroll women in this ground-breaking study and to move our topical Endoxifen a step closer to treating women with MBD. We are also making progress with our proprietary oral Endoxifen and have been evaluating a potential new indication in the pre-surgery, or “window of opportunity,” setting which involves treating newly diagnosed breast cancer patients prior to surgery. We believe this indication could have a quicker clinical and regulatory pathway. We plan to start a Phase 2 study in the next quarter in this window of opportunity setting and/or a Phase 2 study in breast cancer survivors who are “refractory” to tamoxifen,” added Dr. Quay.
The primary endpoint is to determine if topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months of entering the study. The secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups of different strengths of topical Endoxifen) with 30 participants per group. The objective of the study is to determine if MBD is reduced, and if so, the results will drive sample size calculations for a future Phase III study. Enrollment is anticipated to be completed by the end of 2018.