8:24 AM
Dec 07, 2018
 |  BC Extra  |  Clinical News

Imfinzi-tremelimumab combo fails Phase III for head and neck cancer

In yet another setback for tremelimumab, AstraZeneca plc (LSE:AZN; NYSE:AZN) said the anti-CTLA-4 mAb in combination with PD-L1 inhibitor Imfinzi durvalumab missed the primary endpoint of improving overall survival (OS) compared with standard of care (SOC) chemotherapy in the Phase III EAGLE trial to treat squamous cell carcinoma of the head and neck (SCCHN).

Last month, AZ said tremelimumab plus Imfinzi missed the co-primary endpoint of improving OS in the Phase III MYSTIC trial as first-line treatment of non-small cell lung cancer (NSCLC) (see "Imfinzi Fails Again in MYSTIC Trial for First-Line NSCLC").

Imfinzi monotherapy also missed the primary OS endpoint vs. SOC in EAGLE.

The open-label, international trial enrolled 736 patients with recurrent or metastatic SCCHN who had disease progression following platinum-based chemotherapy, regardless of their PD-L1 tumor status. AZ did not disclose detailed data, but said it plans to submit the results for presentation at a medical meeting.

The company expects data in 1H19 from the Phase III KESTREL trial of Imfinzi with and without tremelimumab to treat SCCHN in patients who have not received prior chemotherapy.

AZ in-licensed tremelimumab in 2011. Three years prior, Pfizer Inc. (NYSE:PFE) had discontinued the mAb's development for melanoma after it failed to show an OS benefit in a Phase III trial (see "Tremelimumab, Take Three").

Anti-PD-1 mAbs Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) and Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) are approved to treat recurrent or metastatic SCCHN that has progressed on or after platinum-containing chemotherapy.

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