Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that Wild type ALK, Wild type EGFR status confers therapeutic sensitivity to Cisplatin, Durvalumab, Pemetrexed, Tremelimumab in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to durvalumab in combination with tremelimumab-actl 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) mutations or anaplastic lymphoma kinase (ALK) genomic aberrations. This indication is based on POSEIDON (NCT03164616), 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 Food and Drug Administration:
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with tremelimumab-actl 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) mutations or anaplastic lymphoma kinase (ALK) genomic aberrations.