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, Nab-paclitaxel, Tremelimumab in patients with Non-Small Cell Lung Cancer.

The U.S. Food and Drug Administration granted approval to tremelimumab-actl in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. This indication is based on POSEIDON (NCT03164616), a randomized, open-label, multicenter, active-controlled trial where patients received one of the following chemotherapy regimens: 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 Food and Drug Administration:

IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

Citation

AstraZeneca AB. Imjudo (tremelimumab-actl) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf. Revised November 2022. Accessed October 30, 2024. AstraZeneca AB. Imjudo (tremelimumab-actl) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf. Revised November 2022. Accessed October 6, 2026.

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Contributions

Date Contributor Description
2025-01-10 Van Allen lab Additional FDA approvals for initial version
2022-11-10 Food and Drug Administration Indication received traditional approval.