Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that Wild type ALK and 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 durvalumab in combination with tremelimumab 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:

IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.

Citation

AstraZeneca AB. Imfinzi (durvalumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf. Revised July 2025. Accessed August 29, 2025.