In the waning weeks of the fourth quarter of the 2020 fiscal year, AstraZeneca terminated several clinical programs, including some oncology and heart-related studies, as well as one COVID-19 related trial.
AstraZeneca CEO Pascal Soriot pictured above. (Rob Stothard/Getty Images)
In the waning weeks of the fourth quarter of the 2020 fiscal year, AstraZeneca terminated several clinical programs, including some oncology and heart-related studies, as well as one COVID-19 related trial.
This morning, the U.K. pharma giant announced its year-end financial results that showed a 10% increase in revenue. Chief Executive Officer Pascal Soriot touted the company’s year-long performance that was driven by pipeline achievements, the success of its COVID-19 vaccine developed with Oxford University and its year-end dive into rare diseases with the $39 billion acquisition of Alexion.
In his comments about the full-year results, Soriot pointed to the continued success of branded products like Tagrisso and Farxiga, an SLG2 inhibitor.
But, despite those successes, the company saw some failures, which led to the termination of some of the studies, including two with Farxiga, which has been approved to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Farxiga has also been approved as a monotherapy and as a combination treatment to improve blood sugar control in type 2 diabetes.
Both of the culled Farxiga studies were for heart failure. AstraZeneca killed trials assessing the drug in patients with heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) for strategic purposes, the company said.
During the fourth quarter, AstraZeneca also canceled five different cancer studies, all for safety and efficacy reasons. One of the studies was assessing the company’s PD-1 inhibitor Imfinzi with tremelimumab, an anti-CTLA4 antibody, as a first-line treatment for head and neck squamous cell carcinoma (HNSCC).
Earlier this month, the company reported the Phase III KESTREL study did not meet the primary endpoint of improving overall survival in HNSCC patients whose tumors expressed high levels of PD-L1. Also, the combination of Imfinzi plus tremelimumab did not indicate an OS benefit in ‘all-comer’ patients, a secondary endpoint.
Two of the oncology programs AstraZeneca halted were in prostate cancer. AstraZeneca halted a study of oleclumab and imaradenant for safety and efficacy reasons. A separate prostate cancer study with imaradenant as a standalone treatment was also canceled for safety and efficacy reasons.
Another study terminated was an investigation of AZD9496 as a potential treatment for estrogen receptor-positive breast cancer. AZD9496 is a selective estrogen receptor degrader (SERD) administered orally. It is similar to an older AstraZeneca drug Faslodex, an injectable SERD that has been approved to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, as well as for the treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
Another experimental treatment terminated in the fourth quarter is AZD5153 for solid tumors and hematological malignancies. AstraZeneca noted this study was terminated due to safety and efficacy.
As expected, AstraZeneca also canceled a study assessing its BTK-inhibitor Calquence in COVID-19 patients following a trial failure. In November, the company reported that Calquence (acalabrutinib) failed to meet its primary endpoints in the Phase II CALAVI trials in hospitalized patients with respiratory symptoms of COVID-19.
