Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that Wild type ALK, Wild type EGFR status confers therapeutic sensitivity to Carboplatin, Durvalumab, Tremelimumab in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized tremelimumab in combination with durvalumab and platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) and no sensitizing EGFR mutations or ALK positive mutations. This indication is POSEIDON (NCT03164616), a randomized, multicenter, active-controlled, and open-label study where the specific chemotherapy regime used was based on the histology of the patient's NSCLC.

This statement is based on a regulatory approval from the European Medicines Agency:

IMJUDO in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Citation

AstraZeneca AB. Imjudo (tremelimumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf. Revised March 2024. Accessed March 13, 2024.