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, 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.