Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Carboplatin, Nivolumab, Paclitaxel 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, followed by nivolumab as monotherapy as adjuvant treatment, of patients with resectable non-small cell lung cancer at high risk of recurrence whose tumors have PD-L1 expression >= 1%. This indication is based on CA20977T, randomised, double-blind study consisting of 461 patients. Platinum-based chemotherapy consisted of paclitaxel and carboplatin (any histology); pemetrexed and cisplatin (non-squamous histology); pemetrexed or carboplatin (non-squamous histology); or cisplatin and docetaxel (squamous histology).
This statement is based on a regulatory approval from the European Medicines Agency:
OPDIVO in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression >= 1%.