(Alliance News) - AstraZeneca PLC on Tuesday said the Pacific-2 phase III trial for Imfinzi as an early treatment lung cancer immunotherapy treatment administered with chemoradiotherapy, did not meet its primary endpoint.
The Cambridge-based pharmaceutical company said the primary endpoint for the trial was progression-free survival versus CRT alone for the treatment of patients with unresectable, stage three non-small cell lung cancer.
Imfinzi is a US Food & Drug Administration-approved immunotherapy for cancer, that blocks the interaction of programmed cell death ligand 1 with the PD-1.
"Initial analysis of the safety and tolerability for Imfinzi and CRT in this patient population showed that the profiles were broadly consistent with the known profiles of these treatments, although there was an increased rate of infection observed during the concurrent treatment period in the experimental arm," AstraZeneca explained.
Susan Galbraith, executive vice president of Oncology research & development, said: "Our goal with the Pacific-2 trial was to address a remaining unmet need for patients in this setting by introducing immunotherapy even earlier and concurrently administering Imfinzi with chemoradiotherapy. While today's results did not reach statistical significance, we will learn from this trial, and we remain committed to improving patient outcomes by expanding the benefit of immunotherapy to lung cancer patients across treatment settings."
On Tuesday AstraZeneca also announced that Imfinzi has been approved in China for first line treatment of adult patients with advanced or metastatic biliary tract cancer in combination with chemotherapy.
China's National medical Products Administration approved the drug based on primary results from the Topaz-1 Phase III trial.
Biliary tract cancer is a type of rare cancer that occurs in the bile ducts and gallbladder. According to AstraZeneca, around 211,000 new patients are diagnosed with gallbladder and biliary tract cancer every year. One in five of patients diagnosed are in China.
Executive vice president of the Oncology business unit at AstraZeneca, Dave Frederickson, said: "With this approval for Imfinzi plus chemotherapy, physicians will now be able to offer this global standard-of-care treatment to patients in China, where nearly one in five patients with biliary tract cancer is diagnosed. This important milestone underscores our commitment to bring innovative medicines that transform survival outcomes to people across the globe living with aggressive gastrointestinal tumours such as biliary tract cancer."
Last week, AstraZeneca hailed results of Imfinzi, which in combination with bevacizumab and transarterial chemoembolisation in a phase III trial demonstrated statistically significant and clinically meaningful improvement in progression-free survival in patients with hepatocellular carcinoma eligible for embolisation. The trial was in comparison to solely transarterial chemoembolisation.
Shares in AstraZeneca were down 0.3% at 10,214.00 pence each in London on Tuesday morning.
By Sabrina Penty, Alliance News reporter
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