Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Cisplatin, Gemcitabine, Nivolumab in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of adult patients with resectable non-small cell lung cancer at high risk of recurrence whose tumors haev PD-L1 expression >= 1%. This indication is based on CA209816, a randomized, open-label, phase 3 study where the selection of platinum-based chemotherapy was investigator's choice of paclitaxel and carboplatin, pemetrexed and cisplatin, or gemcitabine and cisplatin.
This statement is based on a regulatory approval from the European Medicines Agency:
OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1%.