On May 8, 2014 AstraZeneca reported the start of the Phase III programme for MEDI4736, an immunotherapy in development for the treatment of non-small cell lung cancer (NSCLC) and other cancers (Press release AstraZeneca, MAY 8, 2014, View Source;astrazeneca-initiates-phase-iii-immunotherapy-study-MEDI4736 [SID:1234500517]). The goal of the PACIFIC trial, the first study in the Phase III NSCLC programme, is to evaluate progression free survival and overall survival of MEDI4736 compared to placebo in patients with locally advanced, unresectable NSCLC (Stage III) following completion of treatment with chemoradiotherapy and no evidence of tumour progression. The PACIFIC trial is the first pivotal study of an immunotherapy in this patient population.
MEDI4736 is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. MEDI4736 is being developed to empower the patient’s immune system and attack the cancer.
A total of 702 patients are anticipated to be randomised into the PACIFIC Phase III study across more than 100 sites globally. The Phase III programme follows the evaluation of clinical activity and the safety profile of MEDI4736 in a Phase I programme. Updated information from early stage studies (monotherapy and early combination data) will be presented at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
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