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 developers working into 2022 on new treatments for breast cancer are Oncolytics Biotech Inc., Roche Holding AG, Pfizer Inc., Incyte Corporation, and AstraZeneca PLC.
Among the cancers being targeted by Oncolytics Biotech Inc. and its flagship immunotherapeutic agent pelareorep, breast cancer is the company’s official primary focus, according to its latest letter to shareholders that reviewed its accomplishments in 2021 and outlined its upcoming 2022 program.
Within its Breast Cancer Program so far, Oncolytics has witnessed a more-than-doubling of overall survival in metastatic HR+/HER2- breast cancer patients treated with pelareorep in IND-213—as seen from study results delivered in 2017.
After analyzing the data more, Oncolytics chose to focus on three achievable objectives put in place by regulators and the company’s pharma partners, representing important steps towards a registrational study. This included: 1. Confirming that pelareorep works through an immunotherapeutic mechanism of action; 2. Determining whether pelareorep synergizes with immune checkpoint inhibitors; and 3. Identifying a biomarker to select patients who are likely to have better clinical outcomes.
As of April 2021, Oncolytics presented cohort data from its AWARE-1 study, being conducted with Roche Holding AG (OTC:RHHBY), showing the company had achieved the first two objectives referenced above.
Later in December at the 2021 San Antonio Breast Cancer Symposium (SABCS), Oncolytics presented a positive safety update from its IRENE Phase 2 Triple-Negative Breast Cancer Trial evaluating the safety and efficacy of pelareorep in combination with the anti-PD-1 checkpoint inhibitor retifanlimab from Incyte Corporation for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC).
Safety data from the trial showed the combination was well-tolerated, with no safety concerns 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.
Incyte Corporation recently gave another update involving its retifanlimab in combination with BriaCell Therapeutics’ lead clinical candidate Bria-IMTTM at the SABCS. Summarized in the update, the overall survival was much higher in the patients in the combination study, suggesting an additive or synergistic effect and supporting the continuation of the study. According to BriaCell’s website, further safety and efficacy data is expected through 2022.
Pfizer, Inc. recently entered into a clinical trial collaboration and supply agreement with Celcuity, where the pharma giant will provide Palbociclib (Ibrance) for use in a phase 3 clinical study being conducted by Celcuity at no cost to the company.
The phase 3 clinical trial is expected to launch in the first half of 2022 assessing the use of the pan-PI3K/mTOR inhibitor gedatolisib (PF-05212384) in combination with palbociclib and fulvestrant for patients with estrogen receptor (ER)–positive, HER2-negative advanced breast cancer. Celcuity will release further details about the clinical trial following discourse and subsequent feedback from the FDA.
Towards the end of 2021, AstraZeneca PLC and partners Daiichi Sankyo announced that the European Medicines Agency (EMA) had validated its Type II Variation Application for trastuzumab deruxtecan (T-DXd; Enhertu) for the treatment of advanced, previously treated HER2-positive breast cancer patients.
Meanwhile, the first patient with HR+, HER2- inoperable metastatic breast cancer was dosed with datopotamab deruxtecan (DS-1062a; dato-DXd) as part of the phase 3 TROPION-Breast01 trial (NCT05104866). The TROP2-directed DXd ADC that is currently being developed by Daiichi Sankyo and AstraZeneca is currently under investigation in the global, randomized, open-label trial at a dose of 6 mg/kg vs investigator’s choice of chemotherapy.
Another method of improving chances in the fight against cancer, is the race to improve early detections. According to the Carol Milgard Breast Center early detection is key.
Roche Holding AG recently kicked in $290 million into a funding round that surpassed $1 billion into liquid biopsy developers Freenome.