British drug major AstraZeneca PLC (AZN.L) announced Friday that the U.S. Food and Drug Administration has approved Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy for the treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer or NSCLC.
The approval was based on the results from the POSEIDON Phase III trial. The company noted that patients treated with a limited course of five cycles of the anti-CTLA-4 antibody Imjudo added to Imfinzi plus four cycles of platinum-based chemotherapy experienced a 23 percent reduction in the risk of death versus a range of chemotherapy options.
An estimated 33 percent of patients were alive at two years versus 22 percent for chemotherapy. The treatment combination also reduced the risk of disease progression or death by 28 percent compared to chemotherapy alone.
The updated results from the trial demonstrated sustained survival benefit, improving overall survival or OS by 25 percent compared to chemotherapy alone.
AstraZeneca presented the updated results from the POSEIDON Phase III trial after approximately four years of follow-up at the European Society of Medical Oncology (ESMO) Congress 2022. It has also been published in the Journal of Clinical Oncology.
Regulatory applications are also currently under review in Europe, Japan and several other countries for this indication based on the POSEIDON results.
The company noted that Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial.
Imfinzi is also approved in various countries for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial.
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