AstraZeneca's Imfinzi fails to reach endpoint in difficult trial
AstraZeneca and its global biologics research and development arm MedImmune announced overall survival results for the Phase III EAGLE trial of Imfinzi (durvalumab) on Friday.
The FTSE 100 pharmaceutical behemoth described EAGLE as a randomised, open-label, multi-centre trial evaluating Imfinzi monotherapy or Imfinzi in combination with tremelimumab - an anti-CTLA4 antibody - compared to standard-of-care 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.
It said Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving overall survival compared to standard-of-care chemotherapy in the “hard-to-treat” patients.
The safety and tolerability profiles for Imfinzi and the combination with tremelimumab were consistent with previous experience.
“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,” said AstraZeneca’s executive vice-president of global medicines development and chief medical officer Sean Bohen.
“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.
“We look 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 the first half of 2019.”
AstraZeneca said it would submit the results from the Phase III EAGLE trial for presentation at a forthcoming medical meeting.