by Dr. C.H. Weaver M.D. 2/2018
The US Food and Drug Administration (FDA) approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose cancer is unresectable and has not progressed after chemoradiation.
About Stage III NSCLC
Stage III NSCLC represents approximately one third of NSCLC’s and was estimated to affect around 100,000 individuals worldwide.2 About half of these patients have cancers that cannot be removed by surgery. For patients with stage III lung cancer that cannot be removed surgically, the current standard treatment is chemoradiation. Although a small number of patients may be cured with the chemoradiation, the cancer will typically progress. New treatment approaches are needed in order to improved the outcome of these individuals.
Imfinzi is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 can be expressed by tumors to evade detection by the immune system through binding to PD-1 on cytotoxic T lymphocytes. Imfinzi blocks the PD-L1 interaction with PD-1, countering the tumor’s immune-evading tactics. Imfinzi is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer. Imfinzi is already FDA approved for certain patients with locally advanced or metastatic bladder cancer.
About PACIFIC Clinical Trial
The PACIFIC clinical evaluated Imfinzi as sequential treatment in patients with locally-advanced, unresectable, stage III NSCLC. Patients received placebo or sequential treatment with Imfinzi for up to 12 months if they had not progressed following standard platinum-based chemotherapy concurrent with radiation.
The new approval in NSCLC was based on these results from the 173-patient PACIFIC trial, in which all of the patients that had non progressive cancer after chemoradiation were treated with Imfinzi or placebo. Imfinzi significantly improved progression-free survival (PFS) compared with placebo; Imfinzi treated patients survived on average 16.8 months without cancer progression compared to only 5.6 months for those treated with placebo.
- Kantar, other market research based on 2016 patient numbers; Globocan 2012. G7 countries include the US, Japan, Germany, the UK, France, Italy and Canada.
- AstraZeneca news release. (2016.) Retrieved from:
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