Regulatory approval
Published by the European Medicines Agency.
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 is written in the approval document as:
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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Durvalumab, Pemetrexed, Tremelimumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Cisplatin, Durvalumab, Pemetrexed, Tremelimumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Cisplatin, Durvalumab, Gemcitabine, Tremelimumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Durvalumab, Gemcitabine, Tremelimumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Durvalumab, Nab-paclitaxel, Tremelimumab |