Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that Wild type ALK and Wild type EGFR status confers therapeutic sensitivity to Cisplatin, Pembrolizumab, Pemetrexed in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. This indication is based on KEYNOTE-189 (NCT02578680), a randomized, multicenter, double-blind, active-controlled trial conducted in 616 patients where the choice of platinum-containing chemotherapy was either carboplatin or cisplatin.
This statement is based on a regulatory approval from the Food and Drug Administration:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.