AstraZeneca’s Imfinzi has failed to improved overall survival (OS) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) for the second time.

An update on the KESTREL Phase III trial of Imfinzi (durvalumab) found that the immunotherapy was unable to meet the primary endpoint of improving OS versus the chemotherapy plus cetuximab treatment regimen in the first-lien treatment of HNSCC patients whose tumours expressed high levels of PD-L1.

A combination of Imfinzi plus the CTLA-4 targeting antibody tremelimumab also failed to to demonstrate an OS patient in all-comer patients.

“Metastatic head and neck cancer is a complex and challenging disease with a poor prognosis,” said Dave Fredrickson, executive vice president, oncology business unit, AZ.

“While we are disappointed by these results, insights from the KESTREL Phase III trial will advance our understanding and application of immunotherapy across our clinical development programme,” he added.

Previously, Imfinzi also failed to to show benefit in HNSCC patients in the Phase III EAGLE trial in 2018.

The Phase III EAGLE trial assessed Imfinzi monotherapy or Imfinzi in combination with tremelimumab, 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.

AZ said at tat time that 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.