FDA expands approval of Imfinzi in non-small cell lung cancer

FDA expands approval of Imfinzi in non-small cell lung cancer

FDA expands approval of Imfinzi in non-small cell lung cancer

Bristol-Myers Squibb, Roche and Merck all have approved products for treating certain patients with advanced lung cancer - but AstraZeneca is now in a position to carve out a niche in treating earlier stage III patients.

The approval is for the expanded use of Imfinzi to treat NSCLC patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT). "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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"Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting".

The approval of Imfinzi is based on the positive PFS data from the phase 3 PACIFIC trial in which Imfinzi improved median PFS of 11.2 months compared to placebo, representing a 48% reduction in relative risk of progression or death vs. placebo in all patients, regardless of PD-L1 status. Detailed interim results of the PACIFIC trial were published online in the New England Journal of Medicine (NEJM). Common adverse events associated with durvalumab in patients with NSCLC include cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash. The trial met one of its primary endpoint of progression-free survival (PFS) in patients with locally-advanced, stage three NSCLC. "Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress", Dr Pazdur said. This differentiates it from Stage IV disease, when the cancer has spread (metastasised) to distant organs. Currently, these patients have no options other than chemotherapy and radiotherapy. The prognosis remains poor and long-term survival rates are low.

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Imfinzi has already received accelerated approval in the United States for the treatment of patients with locally-advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. The drug blocks the interaction of PD-L1 with PD-1 and CD80 proteins, thereby working against the immune-evading tactics of the tumor and releasing the inhibition of immune responses.

AZ is also expecting read-outs from The KESTREL and EAGLE trials of Imfinzi with and without tremelimumab in head and neck cancer.

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