New Drug Developments and Combinations Aiding Badly Neglected Triple-Negative Breast Cancer Patients

A recent study from the National Comprehensive Cancer Center (NCCN) delivered a shocking indictment of the oncology field as a whole, stating that almost 70% of women diagnosed with triple-negative breast cancer (TNBC) do not receive care for their disease that is in accordance with guideline recommendations. The findings came from a team comprised of researchers from the universities of California at Irvine and Riverside. But as dire as the findings were, new developments and combinations are giving hope to this neglected group of patients, from drug developers and producers including Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Immunomedics, Inc. (NASDAQ:IMMU), Incyte Corporation (NASDAQ:INCY), Roche Holding AG (OTC:RHHBY), and AstraZeneca PLC (NYSE:AZN).

A collective term that refers to a subtype of breast cancer that occurs in about 10-20% of diagnosed breast cancers, TNBC is one of the more challenging, complex forms of the disease, and is. It’s more likely to affect younger people, African Americans, Hispanics and those with a BRCA1/2 gene mutation.

Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) recently announced a new investigator-sponsored TNBC study to be managed by Rutgers Cancer Institute of New Jersey, dubbed IRENE.

The Phase 2 trial will investigate the use of Oncolytic Biotech’s proprietary immuno-oncolytic virus platform, pelareorep in combination with Incyte Corporation’s (NASDAQ:INCY) anti-PD-1 checkpoint inhibitor retifanlimab in patients with unresectable locally advanced or metastatic TNBC.

"We are very excited to evaluate pelareorep in TNBC, as prior clinical data show it has the potential to address a pressing unmet need in this challenging indication," said principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School.

Dr. George added: "Checkpoint inhibitors targeting interactions between PD-L1 and PD-1, while commercially successful, are ineffective in up to 80% of TNBC patients. This is often due to an immunosuppressive tumor microenvironment. Checkpoint inhibitors are beneficial in patients who have upregulation of PD-L1 expression in the tumor environment. Clinical data show that systemic pelareorep administration can upregulate PD-L1 expression in tumors across multiple breast cancer subtypes, highlighting its potential to substantially increase the percentage of patients who respond to checkpoint inhibitor therapy. Through the IRENE study, we aim to explore how pelareorep-induced adaptive immune responses synergistically interact with PD-1 inhibition to improve patient outcomes in TNBC."

IRENE’s study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

Pelareorep is a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

However the combination with Oncoltyics Biotech’s pelareorep is not the only TNBC research involving Incyte Corporation (NASDAQ:INCY) in 2020.

Earlier this year, Incyte contributed a grant as part of the Incyte-Vanderbilt Alliance with the Susan G. Komen group. Back in March, researchers from Vanderbilt-Ingram Cancer Center discovered a role for the well-known oncogene MYCN in TNBC.

Also back in March, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) announced another combination of pelareorep’s early findings from an AWARE-1 trial also reported positive preliminary data, this time when combined with top-selling drug Tecentriq from Roche Holding AG (OTC:RHHBY).

The AWARE-1 study’s data suggests that pelareorep induced an increase in tumor PD-L1 expression, demonstrating the synergistic potential between pelareorep and checkpoint inhibitor therapies.

Last year, Tecentriq made history as the first immune-oncology agent to win an FDA approval in triple-negative breast cancer (TNBC). However, disappointing data near the end of the year dampened optimism, until combination studies like that with pelareorep started to gain momentum.

Now hope has been rekindled for the drug targeting TNBC when combined with chemotherapy.

Tecentriq also recently gave Roche positive outcomes when it delivered on meeting its primary endpoint of improved pathological complete response as initial treatment for people with early TNBC, back in mid-June.

Pharma giant AstraZeneca PLC (NYSE:AZN) has also recently shared details of its ongoing trial looking into the effectiveness of pairing drugs to treat triple-negative breast cancer.

AstraZeneca’s ongoing work has confirmed the profound heterogeneity that exists in this difficult to treat form of cancer, and that more novel treatments for both early and advanced TNBC continues to be a significantly unmet need.

The company’s latest efforts have included the pairing of capivasertib+paclitaxel which is in the process of a Phase 3 CAPItello-290 study. Paclitaxel is a chemotherapeutic agent administered through IV infusion, which is standard for TNBC treatment. Whereas capivasertib is an oral potent, selective inhibitor of a protein called AKT, that’s active against three sub-forms.

In April, shares of Immunomedics, Inc. (NASDAQ:IMMU) went up on the announcement of FDA approval its breast-cancer drug, Trodelvy. The drug was approved to treat patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies.

Flash forward to July, and now the company has announced positive results from Phase 2 ASCENT Study of Trodelvy in previously-treated patients with mTNBC.

The confirmatory Phase 3 ASCENT study of Trodelvy (sacituzumab govitecan-hziy) met its primary endpoint of progression-free survival (PFS), as well as key secondary endpoints in brain metastasis negative patients with mTNBC who have previously received at least two prior therapies for metastatic disease.

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