FDA Approves Imjudo With Imfinzi and Chemo for Metastatic NSCLC Without Certain Genetic Mutations

The Food and Drug Administration (FDA) approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

This FDA approval was based on findings from the POSEIDON study, which assessed the efficacy of Imjudo in patients with metastatic NSCLC who were not previously treated. In particular, the study analyzed the effectiveness of Imjudo, Imfinzi and platinum-based chemotherapy compared with platinum-based chemotherapy alone.

The groups also received some combination of maintenance chemotherapy. Patients received treatment until disease progression or unacceptable side effects, according to a news alert from the FDA.

Imjudo plus Imfinzi and chemotherapy significantly improved overall survival (the time from treatment when a patient with cancer is still alive) compared with chemotherapy alone, with a median overall survival of 14 months in the combined treatment group and 11.7 months in the chemotherapy alone group.

Progression-free survival (the time during and after treatment when a patient with cancer lives with the disease without worsening) was also improved in the patients treated with Imjudo, Imfinzi and chemotherapy. In particular, the median progression-free survival was 6.2 months compared with 4.8 months in those treated with chemotherapy alone.

Patients assigned Imjudo, Imfinzi and chemotherapy had an overall response rate (percentage of patients with a partial or complete response to treatment) of 39% versus 24% in patients assigned chemotherapy alone. The median duration of response (the time during which a patient achieves a complete or partial response to therapy) was 9.5 months in the combined treatment group compared with 5.1 months in the chemotherapy alone group.

The most common side effects that occurred in at least 20% of patients in the study included fatigue, nausea, musculoskeletal pain, decreased appetite, diarrhea and rash, according to the news alert.

Severe or life-threatening laboratory abnormalities that occurred in at least 10% of patients were anemia, neutropenia (low levels of neutrophils, a type of white blood cells), lymphocytopenia (low levels of white blood cells called lymphocytes), leukopenia (decrease in disease-fighting cells), hyponatremia (low levels of sodium in blood), increased lipase (potentially indicating acute pancreatitis) and thrombocytopenia (low platelet counts).

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