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, Paclitaxel in patients with Non-Small Cell Lung Cancer.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.