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.
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.
This statement is based on a regulatory approval from the Health Canada:
OPDIVO (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.