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, Gemcitabine, 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) with no sensitizing EGFR mutations or ALK-positive mutations. This indication is based on POSEIDON, a randomized, open-label, and multicenter study where patients received one of the following chemotherapy regimes: Pemetrexed in combination with carboplatin or cisplatin for patients with non-squamous NSCLC, gemcitabine with cisplatin or carboplatin for patients with squamous NSCLC, and nab-paclitaxel with carboplatin for either non-squamous or squamous NSCLC.

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

Tremelimumab AstraZeneca 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. Tremelimumab AstraZeneca (tremelimumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tremelimumab-astrazeneca-epar-product-information_en.pdf. Revised September 2023. Accessed March 25, 2024.