Therapeutic Response

Wild type ALK and Wild type EGFR 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 monograph]. HC.

Health Canada approved nivolumab in combination with platinum-doublet chemotherapy, the neoadjuvant treatment of adult patients with resectable Stage II (>4 cm), IIIA, IIIB (T3-4N2) NSCLC and no known epidermal growth factor Opdivo (nivolumab) receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by OPDIVO as a single agent in the adjuvant setting after surgical resection. This approval is based on CHECKMATE-816, a randomized, open label trial where patients were offered platinum-doublet chemotherapy consisting of either paclitaxel and carboplatin; pemetrexed and cisplatin for non-squamous histology; or gemcitabine and cisplatin for squamous histology.
Opdivo (nivolumab) [package insert]. FDA.

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.