USA News Group – More people are getting breast cancer this year. Around 300,000 women and 2,800 men will find out they have it. While 1 out of every 8 women will hear they have breast cancer sometime in their life, the good news is that more people are beating breast cancer than before. In the UK, a drug called anastrozole, from AstraZeneca PLC (NASDAQ:AZN), is said to potentially halve breast cancer risks and is now being offered to 289,000 women in England. Anastrozole’s roll-out is yet another optimistic development coming from the biotech sector in the war against breast cancer, which includes Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Pfizer Inc. (NYSE:PFE) (NEO:PFE), Arvinas, Inc. (NASDAQ:ARVN), and Olema Oncology, Inc. (NASDAQ:OLMA).
Among the latest developments in the breast cancer field, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) recently shared positive updates at this year’s Society for Immunotherapy of Cancer (SITC) 2023 from its previously completed window-of-opportunity AWARE-1 breast cancer study involving its flagship drug pelareorep.
Immediately following up on that release, Oncolytics also announced the presentation of additional translational data from the AWARE-1 breast cancer study conducted in combination with SOLTI-Innovative Cancer Research at The San Antonio Breast Cancer Symposium (SABCS).
As per the new data, Oncolytics saw that pelareorep helps the body’s defense cells expand inside tumors and in the blood of newly diagnosed breast cancer patients. This included a certain type of these defense cells called tumor-infiltrating lymphocytes (TILs). Also, when they looked closely at the T cells, which are part of the body’s defense against illness, they saw that there were more of these cells in the blood than before.
“We consider these results to be positive and important because they build on additional translational results reported this fall at two other medical meetings, The Society for Immunotherapy of Cancer (SITC) and The European Society for Medical Oncology (ESMO), from the AWARE-1 and GOBLET studies respectively, and provide further support for pelareorep’s unique immunologic mechanism of action,” said Dr. Matt Coffey, President and CEO of Oncolytics. “Taken together, these translational data affirm pelareorep’s ability to enhance T cell infiltration into tumors and expand TILs in the peripheral blood, which have been correlated with tumor response. We intend to incorporate these learnings into the designs of our registrational studies in metastatic breast cancer and pancreatic cancer.”
According to Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics, a review of the AWARE-1 study translational data presented at SABCS and previous conferences demonstrates that pelareorep treatment, especially in combination with atezolizumab, results in: an increase in CelTIL score (which correlates with improved clinical outcomes in breast cancer); increased CD8+ T cell infiltration into tumors; the generation and expansion of T cell clones (especially TILs); and the upregulation of tumor PD-L1 expression.
“These findings confirm that pelareorep remodels the tumor microenvironment and stimulates tumor-directed immune responses, effects we believe are driven by the introduction of pelareorep’s double-stranded RNA into cancer cells.”
“Results from multiple prior studies lead us to believe that pelareorep has the potential to fill very important treatment gaps for both breast and pancreatic cancer patients,” said Dr. Heineman. “The translational data reported this fall emphasize the importance of TIL clone expansion in pelareorep-treated patients and represents an important area for further exploration. We believe that analysis of TIL clone expansion could become a helpful precision tool to provide an early indication of treatment response and serve as a potential guide to patient care with pelareorep.”
Also to be presented at the SABC Symposium will be updated data for Pfizer Inc. (NYSE:PFE) (NEO:PFE) and Arvinas, Inc.’s (NASDAQ:ARVN) novel oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, known as vepdegestrant (ARV-471). In particular, data from a Phase 1b study assessing vepdegestrant in combination with Palbociclib (IBRANCE) will be presented at the symposium.
Arvinas and Pfizer have been collaborating on the co-development and co-commercialization of vepdegestrant since July 2021. According to the terms of the collaboration, Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.
Data from preclinical studies showed that vepdegestrant demonstrated 97% ER degradation in tumor cells. This helps to make tumors smaller. It worked well on its own in tests that used cancer cells from humans but grown in a different environment. It even did better than a common cancer drug, fulvestrant, whether it was used alone or with another kind of cancer medicine called a CDK4/6 inhibitor.
In the case of Olema Oncology, Inc. (NASDAQ:OLMA), it is in the process of testing its lead asset palazestrant alone and in combinations for a subset of patients with metastatic breast cancer. Olema is also set to present at the SABCS, new Phase 1b/2 clinical data of palazestrant in combination with CDK4/6 inhibitor ribociclib.
At the end of October, Olema CEO Sean Bohen said that the first patient in Phase III will be dosed before the end of the year. The Phase III trial, called OPERA-01, is going to sign up 500 people from all over the world. It will have locations in North America, South America, Europe, Australia, and some places in Asia, but it won’t include China or Japan.
One new breast cancer drug combination that recently received US FDA approval is Truqap from AstraZeneca PLC (NASDAQ:AZN) in combination with an older drug, providing another treatment option for patients with the most common type of breast cancer. The FDA’s approval came just over a week after AstraZeneca’s roll-out offer of anastrozole to an estimated 289,000 women in England who are at moderate or high risk of breast cancer by taking the tablet to try and prevent it from developing, according to NHS officials.
“It’s fantastic that this vital risk-reducing option could now help thousands of women and their families avoid the distress of a breast cancer diagnosis,” said Amanda Pritchard, Chief Executive of NHSC England. The drug will be taken as a 1mg tablet once a day for five years.
Back in the USA, the FDA has stated that AstraZeneca’s Truqap can be used in adult patients with the HR-positive/HER2-negative subtype of breast cancer. According to a late-stage study, the drug helped improve the time patients with the gene-altered tumors lived without their disease worsening by 7.3 months.
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