Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that Wild type ALK and Wild type EGFR status confers therapeutic sensitivity to Cisplatin, Nivolumab, Pemetrexed 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.