Therapeutic Response

PD-L1 >= 1% status confers therapeutic sensitivity to Carboplatin in combination with Nivolumab and Paclitaxel in patients with Non-Small Cell Lung Cancer.

Statements

Source and description
Opdivo (nivolumab) [product information]. EMA. 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.
Opdivo (nivolumab) [product information]. EMA. 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).
CARBOplatin (AUC 6) and PACLitaxel 200mg/m2 Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved paclitaxel (200mg/m^2) in combination with carboplatin (AUC 6) and nivolumab for reimbursement as a treatment option for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1% (3 cycles only). The regimen further states that this combination is available in NCIS (00849.1).
Nivolumab 360mg and Chemotherapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved 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 have PD-L1 expression >= 1%. The treatment regimen contians five treatment schedules: (1) nivolumab 360 mg, CARBOplatin (AUC6), and PAClitaxel (200 mg/m^2); (2) nivolumab 360mg, gemcitabine (1000 mg/m^2), and CARBOplatin (AUC5); (3) nivolumab 360 mg, gemcitabine 1250 mg/m^2, and CISplatin 75 mg/m^2; (4) nivolumab 360 mg, PEMEtrexed, and CARBOplatin with folic acid or multivtamin containig 350-1000 micrograms of folic acid; and (5) nivolumab 360 mg, PEMEtrexed, and CISplatin along with folic acid or multivitamin containig 350-1000 mg of folic acid.