February 17, 2016
By Mark Terry, BioSpace.com Breaking News Staff
London-based AstraZeneca and its global biologics research and development unit, MedImmune , announced today that the U.S. Food and Drug Administration had granted MEDI4736 (durvalumab) Breakthrough Therapy designation (BTD).
Durvalumab is a human monoclonal antibody that targets programmed death ligand-1 (PD-L1). It is being investigated for the treatment of PD-L1 positive inoperable or metastatic urothelial bladder cancer when the tumor has progressed during or after treatment by a platinum-based therapy.
“Metastatic bladder cancer is an area of enormous unmet medical need,” said Robert Iannone, senior vice president, head of Immuno-Oncology, Global Medicines Development at AstraZeneca, in a statement. “We are encouraged by this Breakthrough Therapy designation. We look forward to working closely with the FDA to bring durvalumab to bladder cancer patients as soon a possible.”
This announcement is yet another argument in support of AstraZeneca’s strong immuno-oncology program. MEDI4736 has also shown promise in a clinical trial for patients with non-small cell lung cancer (NSCLC). Durvalumab is also being tested in combination with other compounds, including with tremelimumab, an anti-CTLA-4 monoclonal antibody.
In addition, it is being tested in nine immuno-oncology trials, either underway or planned, in NSCLC. It is also being considered for trials in squamous cell carcinoma of the head and neck (SCCHN) and gastric and pancreatic cancers.
In June, Pascal Soriot, chief executive officer of AstraZeneca, said at the American Society of Clinical Oncology (ASCO) meeting last year, “Immuno-oncology has continued to take center stage at ASCO this year, as we see more evidence of the significance of this approach for patients. At AstraZeneca, we have been clear in our belief that combinations hold the key to transforming clinical practice for the patients not benefiting form the currently-available immunotherapies.”
On Feb. 3, AstraZeneca announced that the European Commission (EC) granted conditional marketing authorization for Tagriss (AZD9291, osimertinib) to treat adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T79M mutation-positive non-small cell lung cancer (NSCLC).
“It is an exciting time in the care of patients with lung cancer,” said Matthew Peters, chair of the Global Lung Cancer Coalition, in a statement. “The ability to precisely characterize patients who have different types of lung cancer based on genetic mutations, and predict their response to targeted treatments, offers a more accurate and efficient approach to lung cancer care.”
Analysts have projected that durvalumab could hit sales of more than $1.5 billion by 2020 across all applications.
Breakthrough Therapy designation was designed to improve the development of new drugs for serious conditions that have shown positive early clinical results, and show substantial improvement on a clinically significant endpoint over available therapies, or in the cases of unmet medical need. The BTD for durvalumab was made based on early Phase I trial data, Study 1108, in patients with advanced metastatic urothelial bladder cancer.
It is estimated that there are more than 400,000 bladder cancer incidents worldwide in 2013, with 173,000 deaths. It is noted as an area of unmet medical need, with a five-year survival rate of less than 15 percent.
