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AstraZeneca PLC on Monday said one of its treatments has been approved in the US for treating adults with unresectable liver cancer.
The Cambridge, England-based pharmaceutical company's Imjudo treatment, in combination with Imfinzi, was approved by the US Food & Drug Administration after positive results from the Phase 3 HIMALAYA trial. In the trial patients treated with the combination experienced a 22% reduction in the risk of death against sorafenib, a commonly used oncology drug.
The new dose and schedule of the Imjudo-Imfinzi combination includes a single 300 milligram dose of the anti-CTLA-4 antibody Imjudo added to a 1500mg dose of anti-PD-L1 antibody Imfinzi followed by Imfinzi every four weeks. It is called the STRIDE regimen.
CTLA-4 and PD-L1 are both proteins that act as 'brakes' on the body's immune response. When they bind to certain other proteins, this stops T cells, a type of immune cell, from killing other cells, including cancer cells. Preventing CTLA-4 and PD-L1 from binding to the other proteins increases the ability of T cells to kill cancer cells.
Results showed an estimated 31% of patients treated with the combination were still alive after three years, with 20% of patients treated with sorafenib alive at the same point after the tests.
Dave Frederickson, executive vice president of the oncology business unit, said: "With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to enhance the immune response against their cancer."
Shares in AstraZeneca were trading 0.2% higher at 9,739.00 pence each in London on Monday morning.
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