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Vancouver, BC –January 20, 2021 – USA News Group – As the 2021 San Antonio Breast Cancer Symposium (SABCS) comes to a close, many of this year’s presenters provided very encouraging results from trial data in the fight against cancer. According to Research and Markets, the global breast cancer drugs market is expected to grow to $19.49 billion by 2025 at a CAGR of 7.1%. Among the biotech companies and treatments that provided updates over the 4-day event were Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Incyte Corporation (NASDAQ:INCY), Gilead Sciences, Inc. (NASDAQ:GILD), Arvinas, Inc. (NASDAQ:ARVN) and Pfizer, Inc. (NYSE:PFE).
On the last day of the event, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) presented a positive safety update from its IRENE Phase 2 Triple-Negative Breast Cancer Trial evaluating the safety and efficacy of its intravenously delivered immunotherapeutic agent pelareorep in combination with the anti-PD-1 checkpoint inhibitor retifanlimab from Incyte Corporation (NASDAQ:INCY) for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC).
The trial’s safety data shows that the combination has been well-tolerated, as no safety concerns were noted in any of the patients enrolled in the trial at the time of reporting.
The IRENE study remains ongoing and will continue to enroll patients at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center.
“Prior clinical studies have shown that pelareorep upregulates tumor PD-L1 expression and reverses immunosuppressive TMEs,” said Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey, Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, and principal investigator of the trial. “These findings suggest that pelareorep can address a pressing unmet need in TNBC by synergizing with PD-1 inhibition to increase the proportion of patients responding to therapy. We look forward to evaluating this hypothesis through the IRENE study’s continued advancement and are pleased that the pelareorep-retifanlimab combination has been well-tolerated in each of the patients enrolled in the trial.”
According to the American Cancer Society, triple-negative breast cancer (TNBC) accounts for about 10-15% of all breast cancers. The term triple-negative breast cancer refers to the fact that the cancer cells don’t have estrogen or progesterone receptors and also don’t make too much of the protein called HER2.
In addition to evaluating the safety and efficacy of pelareorep plus retifanlimab, IRENE is also designed to assess changes in PD-L1 expression and correlations between treatment outcomes and changes in peripheral blood T cell populations. This could provide a potential biomarker of pelareorep response that may enable the success of future registrational trials by allowing for the early identification of patients most likely to respond to therapy.
Another update involving retifanlimab from Incyte Corporation (NASDAQ:INCY) was in combination with Bria-IMTTM.
Gilead Sciences, Inc. (NASDAQ:GILD) gave a presentation showing new data from the Phase 3 ASCENT study evaluating Trodelvy® (sacituzumab govitecan-hziy) in relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease.
In particular, the Gilead presentation demonstrated Trodelvy®’s clinical benefit for black patients consistent with TNBC, while also highlighting disparities causing worse outcomes for black women when compared to white women.
“Black women are almost three times more likely to be diagnosed with TNBC and may experience worse clinical outcomes compared with white women,” said Lisa Carey, MD, Medical Director of the UNC Breast Center, the Physician-in-Chief of the North Carolina Cancer Hospital and Associate Director of Clinical Research at UNC Lineberger Comprehensive Cancer Center. “This inequality is driven by comorbidities, differences in TNBC biology and other health disparities, which is why understanding how sacituzumab govitecan can work in these patients is so critical. This analysis of the Phase 3 ASCENT study confirms that [Trodelvy®] delivered the same clinical benefit for black women as the overall population in second-line locally advanced or metastatic TNBC.”
In this subgroup analysis of black patients, Trodelvy improved progression-free survival (PFS), with a 56% reduction in the risk of disease worsening or death (HR: 0.44; 95% CI: 0.24-0.80; P=0.008) and a median PFS of 5.4 months (n=28) versus 2.2 months with chemotherapy (n=34). Trodelvy also extended median overall survival to 13.8 months versus 8.5 months with physician’s choice of chemotherapy (HR: 0.64; 95% CI: 0.34-1.19; P=0.159). Additionally, Trodelvy demonstrated a higher overall response rate (32% versus 6%) and clinical benefit rate (43% versus 15%) compared with physician’s choice of chemotherapy in this subgroup.
Arvinas, Inc. (NASDAQ:ARVN) and Pfizer, Inc. (NYSE:PFE) both co-announced that ARV-471, a novel PROTAC® estrogen receptor (ER) degrader, continues to show a favorable tolerability profile and robust ER degradation in updated phase 1 dose escalation data.
ARV-471 is being co-developed for the treatment of patients with locally advanced or metastatic ER-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER+/HER2-).
Data from the Phase 1 dose escalation study demonstrated antitumor activity in CDK4/6 inhibitor-pretreated patients with a clinical benefit rate (CBR) of 40% in 47 evaluable patients. “These results continue to suggest that ARV-471 has the potential to become a first-in-category treatment, and a new standard of care, for ER+/HER2- breast cancer patients,” said John Houston, Ph.D., Chief Executive Officer at Arvinas. “The profile we see emerging for this drug candidate continues to validate our PROTAC® protein degrader platform, with ARV-471 showing clear signals of clinical benefit in a heavily pretreated patient population, including tumor shrinkage and good tolerability.”
ARV-471 continues to demonstrate a favorable tolerability profile. Robust ER degradation was observed at all dose levels, reaching 89% reduction of ER. These data support and further validate the evaluation of ARV-471 as a potential treatment for metastatic breast cancer that is ongoing in a Phase 1b combination study with IBRANCE® (palbociclib) and a Phase 2 monotherapy dose expansion study.
“We are excited by these results and believe ARV-471 is a promising ER-targeting investigational medicine,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “It is encouraging to see ARV-471 continuing to show durable efficacy and tolerability in heavily pre-treated patients with ER+ breast cancer who have limited treatment choices.”
For more information please visit: https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/
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