British pharmaceutical firm AstraZeneca has initiated a Phase III programme for MEDI4736, a human monoclonal antibody, being developed as an immunotherapy for the treatment of non-small cell lung cancer (NSCLC) and other cancers.
The first study in the Phase III NSCLC programme is the PACIFIC trial and it is designed to assess progression free survival and overall survival of MEDI4736 compared with placebo in patients with stage III NSCLC following completion of treatment with chemoradiotherapy and no evidence of tumour progression.
The company said that PACIFIC clinical 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 tumour's immune-evading tactics.
The company is developing MEDI4736 to increase power in the patient's immune system and attack the cancer.
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 are expected to be randomised in the PACIFIC Phase III trial across more than 100 sites globally.
The Phase III NSCLC programme follows the assessment of clinical activity and the safety profile of MEDI4736 in a Phase I programme.
AstraZeneca's biologics research and development arm MedImmune is building a comprehensive immuno-oncology programme, including MEDI4736, tremelimumab, MEDI0680 and MEDI6469.
MedImmune is actively exploring both monotherapy and combination therapies across a range of tumour types.
Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.