AstraZeneca said that the combination of its Imfinzi (durvalumab) monotherapy and tremelimumab has failed to improve overall survival (OS) rate compared to standard-of-care (SoC) chemotherapy in a head and neck cancer trial.
The phase II Eagle trial is a randomized, open-label and multi-centre trial designed to assess Imfinzi monotherapy and Imfinzi in combination with anti-CTLA4 antibody tremelimumab against SoC chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The trial was carried out at 169 centers in 24 countries, including the US, Europe, South America, Japan, Korea, Taiwan, Israel and Australia.
According to the company, the primary endpoint of the trial was OS and the secondary endpoints comprised of progression-free survival, landmark OS, objective response rate and duration of response.
Around 880,000 patients have been diagnosed with head and neck cancer across the world last year, said AstraZeneca.
Imfinzi is a human monoclonal antibody, which binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80.
Imfinzi secured approval for unresectable and stage III non-small cell lung cancer (NSCLC) in over 40 countries, including the US, EU, and Japan.
Imfinzi has also secured approval for previously-treated patients with advanced bladder cancer in the US, Canada, Brazil, Israel, India, UAE, Australia and Hong Kong.
In addition, Imfinzi is under assessment as a monotherapy and in combination with tremelimumab, to treat patients with NSCLC, small-cell lung cancer (SCLC), bladder cancer, head and neck cancer and other solid tumors.
Tremelimumab is a human monoclonal antibody and potential new medicine, which focused on the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “The prognosis for recurrent or metastatic head and neck squamous cell cancer is very poor and new treatments for this group of cancers are urgently needed.
“While these results are disappointing, we remain committed to evaluating the potential of Imfinzi and other innovative medicines for patients with head and neck cancer.”