Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that Wild type ALK, Wild type EGFR status confers therapeutic sensitivity to Cisplatin, Gemcitabine, Nivolumab in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to nivolumab in combination with platinum-doublet chemotherapy for the neoadjuvant treatment, followed by single-agent nivolumab as adjuvant treatment after surgery, of adult patients with resectable (tumors >= 4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements. This indication is based on CHECKMATE-816 (NCT02998528), a randomized, open label trial where patients received either: carboplatin with paclitaxel for either histology, cisplatin with pemetrexed for non-squamous histology, or cisplatin with gemcitabine for squamous histology.
This statement is based on a regulatory approval from the Food and Drug Administration:
OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adult patients with resectable (tumors >=4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery.