First study in the Phase III NSCLC programme, the PACIFIC trial is designed to evaluate progression free survival and overall survival of MEDI4736 compared to placebo in patients with stage III NSCLC after completion of treatment with chemoradiotherapy and no evidence of tumor progression.
According to the company, PACIFIC trial is the first pivotal trial of an immunotherapy in this patient population.
MEDI4736 is directed against programmed cell death ligand 1 (PD-L1) and it blocks signals from PD-L1, countering the tumor’s immune-evading tactics.
AstraZeneca executive vice president of Global Medicines Development and chief medical officer Briggs Morrison said this is a significant milestone for the company and MedImmune.
"MEDI4736 is an important molecule in our immuno-oncology portfolio and its entry into Phase III clinical trials is further evidence of our commitment to invest in distinctive science in our core therapy areas, and to rapidly progress our immuno-oncology pipeline," Morrison said.
"Lung cancer is still the leading cancer killer; there is a clear need for more treatment options to provide patients with a better chance of beating the disease. We believe MEDI4736, and immunotherapies more broadly, hold the potential to shape the future of cancer treatment."
A total of 702 patients will be randomised in the PACIFIC Phase III trial across more than 100 sites globally.
The Phase III NSCLC program follows the evaluation of clinical activity and the safety profile of MEDI4736 in a Phase I program.
MedImmune, the biologics research and development arm of AstraZeneca, is building a comprehensive immuno-oncology program including MEDI4736, tremelimumab, MEDI0680 and MEDI6469.
Image: A total of 702 patients will be randomised in the PACIFIC Phase III trial of MEDI4736 to treat NSCLC. Photo: courtesy of Praisaeng/ freedigitalphotos.net.