Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Ipilimumab, Nivolumab in patients with Esophageal Squamous Cell Carcinoma.

Health Canada approved nivolumab, in combination with ipilimuab, for the treatment of adult patients with unresectable or metastatic ESCC, with tumour cell PD-L1 expression ≥ 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC.

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

OPDIVO (nivolumab), in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic ESCC, with tumour cell PD-L1 expression ≥ 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC.

Citation

Bristol-Myers Squibb Canada. Opdivo (nivolumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00076152.PDF. Revised June 2024. Accessed June 2025.