by Dr. C.H. Weaver M.D. 2/2018
The US Food and Drug Administration (FDA) today 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
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.
The new approval in NSCLC is based on 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 5.6 months for those treated with placebo.
The findings were previously published online in the New England Journal of Medicine.
This is an important advance for individuals with stage III NSCLC. Numerous previous trials have attempted to improve outcomes in this patient population, and all have failed. Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation,
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