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Phase III Immunotherapy Study Evaluates MEDI4736 in Patients With Lung Cancer

Monoclonal antibody counters tumors’ immune-evading tactics

A phase III clinical trial program has been initiated to investigate the immunotherapy agent MEDI4736 (MedImmune/AstraZeneca) in the treatment of non–small-cell lung cancer (NSCLC) and other cancers.

The goal of the PACIFIC trial — the first study in the program — is to evaluate progression-free survival and overall survival with MEDI4736 compared with placebo in patients with locally advanced, unresectable NSCLC (stage III) following completion of treatment with chemoradiotherapy and with no evidence of tumor progression. The PACIFIC trial is the first pivotal study of an immunotherapy in this population.

MEDI4736 is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumor’s immune-evading tactics.

A total of 702 adult patients (aged 18 years or older) are expected to be enrolled into the PACIFIC trial at more than 100 sites worldwide. The estimated study completion date is July 2019.

The new phase III program follows the evaluation of the clinical activity and safety profile of MEDI4736 in a phase I program. Updated information from early-stage studies (monotherapy and early combination data) will be presented at this year’s American Society of Clinical Oncology (ASCO) annual meeting.

According to the latest statistics from the World Health Organization (WHO), lung cancer was responsible for 1.59 million deaths (nearly 20% of all deaths from cancer) in 2012. NSCLC is the most common form of lung cancer, and the National Comprehensive Cancer Network guidelines estimate that approximately one-third of patients are at stage III of the disease when diagnosed. While most NSCLC patients initially benefit from chemoradiotherapy, their cancer eventually progresses, and they die of metastatic disease.

Sources: AstraZeneca; May 8, 2014; and ClinicalTrials.gov; April 2014.

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