FDA Clears Imfinzi/Imjudo Combination for Lung Cancer

The FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy to treat adult patients with metastatic non-small cell lung cancer (NSCLC). Imjudo is a monoclonal antibody that targets the activity CTLA-4; Imfinzi is a PD-L1 inhibitor.

In the United States, lung cancer is the second most commonly diagnosed cancer, with more than 236,000 patients expected to be diagnosed in 2022. For patients with metastatic NSCLC, prognosis is particularly poor, as only about 8% will live beyond five years after diagnosis.

Melissa Johnson, M.D.

“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,” lead investigator Melissa Johnson, M.D., director of Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology in Nashville, said in a press release. “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 approval was based on the results from the POSEIDON phase 3 trial. 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% reduction in the risk of death versus a range of chemotherapy options. An estimated 33% of patients were alive at two years versus 22% for chemotherapy. This treatment combination also reduced the risk of disease progression or death by 28% compared with chemotherapy alone.

Related: FDA Clears Novel Liver Cancer Combo Treatment

Last month, the FDA approved the combination of Imjudo and Imfinzi to treat patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. Imfinzi is approved in the United States and several other countries in combination with chemotherapy for the treatment of locally advanced or metastatic biliary tract cancer based on the TOPAZ-1 Phase III trial.