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 in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration (FDA) granted approval to durvalumab in combination with platinum-containing chemotherapy for the neoadjuvant treatment, followed by durvalumab as a single agent as adjuvant treatment after surgery, of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This indication is based on AEGEAN (NCT03800134), a randomized, double-blind, placebo-controlled, multicenter trial where the choice of platinum-containing chemotherapy was dependent on tumor histology. Specifically, patients with squamous tumor histology received either carboplatin with paclitaxel or cisplatin with gemcitabine, and patients with non-squamous tumor histology received either pemetrexed with carboplatin or pemetrexed with cisplatin.
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 platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.