Therapeutic Response

Wild type ALK and Wild type EGFR status confers therapeutic sensitivity to Cisplatin in combination with Durvalumab and Pemetrexed in patients with Non-Small Cell Lung Cancer.

Statements

Source and description
Imfinzi (durvalumab) [package insert]. FDA.

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.
Imfinzi (durvalumab) [product information]. EMA.

The European Medicines Agency (EMA) has authorized durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no EGFR mutations or 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.