Ahead of overall survival data reveal from PACIFIC, AstraZeneca's Imfinzi gains EU clearance for locally-advanced, unresectable NSCLC

AstraZeneca said Monday that the European Commission approved Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small-cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1 percent of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy. The company noted that the clearance is based on results from the Phase III PACIFIC trial.  

Dave Fredrickson, head of AstraZeneca's oncology business, remarked "Imfinzi is the only immunotherapy to be approved in this curative-intent setting." Last year, the company reported that in the PACIFIC study, Imfinzi significantly prolonged progression-free survival (PFS) by more than 11 months versus placebo in patients with Stage III unresectable NSCLC who did not progress following platinum-based chemotherapy plus radiation therapy.  

Results showed that for the co-primary endpoint, PFS in the Imfinzi group was 16.8 months, compared to 5.6 months in the placebo arm. At the time, AstraZeneca indicated that overall survival (OS), the other co-primary goal, remained under analysis in the trial, later reporting that this endpoint had also been achieved. The drugmaker is scheduled to present OS data from the study at the World Conference on Lung Cancer (WCLC) on September 25.  

Approval for this indication comes after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion backing approval of the drug in July.  

Imfinzi was initially granted accelerated approval in the US for the treatment of certain patients with advanced or metastatic urothelial carcinoma. The therapy has additionally been authorised for the treatment of unresectable Stage III non-small-cell lung cancer in patients who did not experience disease progression after concurrent platinum-based chemotherapy and radiation therapy. 

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