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Imfinzi approved in Japan for Stage III nsclc
Imfinzi approved in Japan for Stage III nsclc.
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[{"type":"text","content":"\n \nRNS Number : 1163T AstraZeneca PLC 02 July 2018 \n\n02 July 2018 07:00 BST\n \nImfinzi approved in Japan for unresectable Stage III non-small cell lung cancer\n \nImfinzi is the only immunotherapy approved for unresectable Stage III NSCLC\n \nApproval is based on the Phase III PACIFIC trial\n \nAstraZeneca and MedImmune, its global biologics research and development arm, today announced that the Japanese Ministry of Health, Labour and Welfare approved Imfinzi (durvalumab) as maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC).\n \nDave Fredrickson, Executive Vice President, Head of the Oncology Business Unit said: \"Non-small cell lung cancer is a leading cause of death in Japan, and we are dedicated to bringing new treatment options to patients as quickly as possible. As the only immunotherapy approved in the curative-intent, Stage III lung cancer setting, Imfinzi has the potential to change the treatment paradigm for patients diagnosed with this disease.\"\n \nThe approval of Imfinzi is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial in unresectable Stage III NSCLC. In the trial, Imfinzi demonstrated an improvement in median PFS of 11.2 months compared to placebo. Imfinzi improved other meaningful outcomes such as time to distant metastasis or death and overall response rates. Detailed results of the PACIFIC trial were published in the New England Journal of Medicine (NEJM).\n \n\n\n\nPFS (first primary endpoint)1\n\n\nImfinzi\n(N=476)2\n\n\nPlacebo\n(N=237)2\n\n\n\n\nMedian in months\n(95% CI)\n\n\n16.8\n(13, 18.1)\n\n\n5.6\n(4.6, 7.8)\n\n\n\n\nHazard ratio\n(95% CI)3, 4\n\n\n0.52 (0.42, 0.65)\n\n\n\n\np-value3, 5\n\n\n<0.0001\n\n\n\n1 Blinded Independent Central Review (BICR).\n2 Among the ITT population, 7% in the Imfinzi arm and 10% in the placebo arm had non-measurable disease as assessed by BICR according to RECIST v1.1.\n3 Stratified by sex, age, and smoking history.\n4 Pike estimator.\n5 Compared with allocated α of 0.0104 (Lan DeMets spending function approximating O'Brien Fleming boundary) for interim analysis.\n \nThe incidence and severity of adverse events were comparable for patients receiving Imfinzi vs. patient...