AstraZeneca's Imfinzi, tremelimumab combination suffers further setback with failure in head and neck cancer study

AstraZeneca announced Friday that in a Phase III study, the PD-L1 inhibitor Imfinzi as monotherapy and in combination with the anti-CTLA4 antibody tremelimumab failed to significantly improve overall survival (OS) versus 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.

The EAGLE trial randomised patients with recurrent or metastatic HNSCC who experienced progression following platinum-based chemotherapy, regardless of their PD-L1 tumour status, to receive Imfinzi monotherapy or Imfinzi in combination with tremelimumab compared to standard-of-care chemotherapy. The study's primary endpoint was OS, while secondary goals included progression-free survival, landmark OS, objective response rate and duration of response. AstraZeneca said it will submit the trial's results for presentation at an upcoming medical meeting.

Chief medical officer Sean Bohen called the findings "disappointing," adding  "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."

Last month, AstraZeneca reported that in the Phase III MYSTIC study, Imfinzi as monotherapy and in combination with tremelimumab in previously-untreated patients with Stage IV non-small-cell lung cancer (NSCLC) failed to significantly improve OS versus standard-of-care platinum-based chemotherapy. At the time, the company suggested that the data "support further analysis in exploratory subgroups."

Imfinzi is approved for unresectable, Stage III NSCLC in more than 40 countries, including the US, EU and Japan. The drug, which generated third-quarter sales of $187 million, is also approved for previously-treated patients with advanced bladder cancer in a number of markets, including the US.

For related analysis, see ViewPoints: No upside surprise from MYSTIC; AstraZeneca to accelerate its earlier-stage focus?

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