AstraZeneca PLC (LON:AZN) has resumed patient enrolment in two trials of a cancer drug combination that analysts have suggested is critical to the pharma giant’s future.
The two trials, phase III KESTREL and EAGLE, are investigating the use of durvalumab as a monotherapy and in combination with tremelimumab in head and neck cancer.
Astra stopped recruitment at the behest of the US Food and Drug Administration after bleeding by patients.
The FDA has now lifted the partial clinical hold following a review of the comprehensive analysis provided by the company.
Bleeding is a known complication in treatments of head and neck cancers primarily due to the nature of the underlying disease, the proximity of tumours to major blood vessels and use of prior cancer therapies, Astra said.
Some analysts believe that durvalumab/tremelimumab as an immunotherapy treatment is potentially the future for Astra.
Cantor Fitzgerald said while Astra lags well behind rivals Bristol Myers, Merck and Roche in single drug treatments (monotherapies) in combination therapy (principally durvalumab/tremelimumab) it may be may able to leapfrog the competition.
The durva/treme combination may ultimately form the backbone of future combinations in cancer and other areas such as DNA damage repair (DDR).
Another key durvalumab/tremelimumab trial MYSTIC (for first line lung cancer) is also due next year, where if successful peak sales may be as much as US$5bn a year.
In Exane’s view, the investment case for AstraZeneca boils down to three things: pipeline, pipeline and pipeline.