It’s been a year and a half since the US Food and Drug Administration approved the first targeted immunotherapy in the treatment of triple-negative breast cancer (TNBC) leading the way to what’s been hailed as a “new clinical paradigm”. This year has continued to deliver new optimism in the fight against TNBC, as new clinical trials are being prepared and launched by pharma developers including the work of Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Incyte Corporation (NASDAQ:INCY), ERYTECH Pharma S.A. (NASDAQ:ERYP), Oncocyte Corporation (NYSE:OCX), and AstraZeneca PLC (NYSE:AZN).
Most recently a new study was kicked off at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center, through a collaboration between Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) and Incyte Corporation (NASDAQ:INCY).
Oncolytics Biotech announced the dosing of the first patient, in what’s been dubbed the IRENE Study, it is a single-arm, open-label, phase 2 study involving 25 enrolled patients, evaluating the combination of the company’s flagship asset pelareorep and Incyte’s retifanlimab for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer.
"The paucity of treatment options in metastatic triple-negative breast cancer combined with its aggressive clinical behavior results in a poorer prognosis when compared to other subtypes of breast cancer,” said Dr. Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School and Principal Investigator in the IRENE study. “This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option. I'm looking forward to getting this study underway to potentially make an impact in the lives of patients affected with metastatic triple-negative breast cancer."
Dr. Mridula has expressed their research team’s targets evaluate induced adaptive responses of pelareorep that interacts with inhibition of PD-1 in patients suffering from TNBC.
IRENE is an extension of Oncolytics’ lead breast cancer program into TNBC, a subtype of the new disease. The main endpoints of the study are safety and objective response. In the secondary endpoint, the research teams will study the overall survival and progression-free survival of the patients.
Oncolytics’ pelareorep has already shown that it can generate autoreactive T cells, which can boost the efficacy of anti-PD-1 agents, which is why it’s being tested in combination with retifanlimab. Essentially pelareorep unregulates PD-L1 expression in the tumors. This prior clinical data shows pelareorep has the potential to address a pressing unmet need in challenging TNBC indications.
In another combination study, the Canadian Cancer Trials Group recently launched a Phase 2 study of a combination of Imfinzi from AstraZeneca PLC (NYSE:AZN) with an investigational compound that stops cell division by inhibiting a protein called polo-life kinase 4.
Both AstraZeneca’s Imfinzi and Oncolytics Biotech’s pelareorep are a type of immunotherapy called an immune checkpoint inhibitor that prevents a protein called PD-L1 from interacting with the PD-1 receptor in immune cells. Cancer cells often use this interaction to evade immune attacks.
“Immunotherapy in combination with chemotherapy has shown promise in [TNBC]; however, non-chemotherapy combinations which avoid those toxicities and may have activity in the chemorefractory setting are of particular interest,” said David Cescon, MD, medical oncologist at Princess Margaret Cancer Centre.
According to a recent release from Oncocyte Corporation (NYSE:OCX), there are close to 3,000 ongoing immune-therapy clinical trials in the US alone, and up to 750,000 patients who may be eligible for immunotherapy treatment each year.
Through the sharing of peer-reviewed research, Oncocyte demonstrated the utility of its TNBCType-IM assay to identify the most suitable cell lines to help biopharma and academic researchers develop new TNBC treatments. Published research demonstrates the test’s ability to work consistently both in vitro and in vivo in six cell lines used in drug development, suggesting promise in research applications.
Another novel drug candidate, eryaspase, is being evaluated to target cancer cells’ altered amino acid metabolism, primarily in metastatic pancreatic, but also in TNBC.
Eryaspase’s developers, ERYTECH Pharma S.A. (NASDAQ:ERYP) are currently aiming to enroll 64 patients in its phase 2 of a trial for its lead asset to treat TNBC. For this indication, eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone, in the first-line setting is being evaluated in the ongoing phase 2/3 TRYbeCA2 trial among patients with metastatic TNBC.
Since the FDA’s March 2019 accelerated approval of the combination of atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) for the frontline treatment of patients with unresectable locally advanced or metastatic PD-L1–positive TNBC, there has clearly been plenty of optimism and targeted improvements.
"It is a really exciting time in breast cancer," said Hope S. Rugo, MD, professor in the Department of Medicine and director of Breast Oncology and Clinical Trials Education at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center in an interview with Oncology Nursing News. "We've seen so many advances in the [immuno-oncology arena] in a disease where we haven't had good treatment options."
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