AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, along with MedImmune, its global biologics research and development arm, announced on Friday overall survival (OS) results for the phase III EAGLE trial.
EAGLE is a randomised, open-label, multi-centre trial evaluating Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression following platinum -based chemotherapy, regardless of their PD-L1 tumour status.
This trial was conducted at 169 centres across 24 countries including the US, Europe, South America, Japan, Korea, Taiwan, Israel and Australia. The primary endpoint of the trial was OS, while secondary endpoints included progression-free survival, landmark OS, objective response rate and duration of response.
Reportedly, Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving OS compared to SoC chemotherapy in these hard-to-treat patients. The safety and tolerability profiles for Imfinzi and the combination with tremelimumab were consistent with previous experience.
According to the company, while these results are disappointing, it remains committed to evaluating the potential of Imfinzi and other innovative medicines for patients with head and neck cancer.
The company added that it is looking forward to seeing the results of the phase III KESTREL trial of Imfinzi and tremelimumab in patients who have not received prior chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma in H1 2019.
AstraZeneca will submit the results from the phase III EAGLE trial for presentation at a forthcoming medical meeting.
AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.
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