TISLELIZUMAB-JSGR INJ,SOLN

Clinical Criteria Summary

First-line treatment, in combination with a platinum-containing regimen, for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (> 1)
Subsequent therapy as a single agent for unresectable or metastatic ESCC if no prior immune checkpoint inhibitor has been used
First-line treatment, in combination with platinum- and fluoropyrimidine-based chemotherapy, for unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (> 1)
Population includes patients with unresectable, recurrent, or metastatic ESCC; untreated, unresectable, or metastatic HER2-negative gastric/GEJ adenocarcinoma
Exclusions: Active or uncontrolled CNS disease, active autoimmune disease, medical condition requiring systemic corticosteroids or immune suppressants, fistula or esophageal obstruction (ESCC), prior ICI therapy (for subsequent ESCC therapy)

150 mg IV every 2 weeks, 200 mg IV every 3 weeks, 300 mg IV every 4 weeks, or 400 mg IV every 6 weeks
Dosage form: Injection, 100 mg/10 mL (10 mg/mL) solution in a single dose vial

Monitor for severe and fatal immune-mediated adverse reactions
Monitor for infusion-related reactions (occur in 5% of patients; > grade 3 in 0.2%)
Manage infusion-related reactions by slowing and/or interrupting the infusion rate
Assess risk for complications of allogeneic hematopoietic stem cell transplantation (GVHD, hepatic veno-occlusive disease)
Assess embryo-fetal toxicity; can cause fetal harm when administered to a pregnant woman

VA Oncology Clinical Pathways for Esophageal Cancer (v7.2025) and Gastric Cancer (v4.2025) do not include tislelizumab
Preferred 1L regimens per NCCN/UpToDate direct to nivolumab or pembrolizumab-containing regimens based on PD-L1 CPS thresholds (> 1, > 5, > 10) and histology (adenocarcinoma vs. squamous cell carcinoma)
FDA ODAC meta-analysis indicates survival benefit for ICI addition in advanced ESCC only with CPS > 1, not CPS < 1
Assessment indicates tislelizumab does not appear to provide additional benefit over the current ICI landscape for ESCC or gastric/GEJ adenocarcinoma

Autoimmune disease
Immunosuppression requiring a corticosteroid equivalent to > 10 mg per day of prednisone
Primary Immunodeficiency
History of allogeneic hematopoietic stem cell or solid organ transplant
Known pregnancy
Lactating

Care is provided by a VA/VA Community Care oncology or hematology provider
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Goals of care and role of Palliative Care consult have been discussed and documented

For females who can become pregnant: Pregnancy must be excluded prior to receiving tislelizumab
For females who can become pregnant: Counseling provided on potential risks vs. benefits of treatment and the use of effective contraception during therapy and for 4 months after stopping treatment