US FDA Approves Imfinzi and Imjudo with Chemotherapy for Lung Cancer

Imfinzi and Imjudo for Lung CancerAstraZeneca’s Imfinzi in combination with Imjudo plus platinum-based chemotherapy has been approved for treatment of patients with Stage IV non-small cell lung cancer (NSCLC). The approval has been made by the Food and Drug Administration (FDA) based on the results from the POSEIDON Phase III trial. Melissa Johnson, MD, Director of Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology in Nashville, Tennessee, and a lead investigator in the POSEIDON Phase III trial, said: “Metastatic non-small cell lung cancer remains a significant treatment challenge because many patients’ tumors do not respond well to standard therapies, including checkpoint inhibitors. The approval of this dual immunotherapy regimen with chemotherapy introduces a new, generally well-tolerated treatment option for patients with this devastating disease and gives them the chance to benefit from the long-term survival advantage seen with CTLA-4 inhibition.”

The updated results from the POSEIDON Phase III trial have been published in the Journal of Clinical Oncology demonstrated sustained survival benefit and improved overall survival by 25% as comparison to chemotherapy alone. About 25% of patients treated with the combination were alive at three years as compared to 13.6% who were treated with chemotherapy alone. Imfinzi is the only approved immunotherapy and global standard of care in unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiation therapy. It is approved in the US and several other countries in combination with chemotherapy for treatment of locally advanced or metastatic biliary tract cancer based on the TOPAZ-1 Phase III trial.

The trial population included patients with either squamous, or non-squamous disease, and full range of PD-L1 expression levels.  The patients were treated with dose of Imfinzi, Imjudo with up to four cycles of chemotherapy every three weeks. This was then followed by maintenance treatment where doses were increased and pemetrexed maintenance treatment was allowed in all arms in patients with non-squamous disease if given during the induction phase.

The information shared in this blog is for educational purposes only. You should consult your healthcare professional for any medical needs.

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