Elvina Almuradova, Associate Professor at Medicana Health Group, posted on LinkedIn:
“The FDA has approved tislelizumab-jsgr (Tevimbra) in combination with chemotherapy as a first-line treatment for patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1.
Phase 3 RATIONALE 305 trial showed that tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone in patients with PD-L1 tumor expression.
- Median OS was 17.2 months with tislelizumab + chemo vs. 12.6 months with chemo alone (HR 0.74, P = .006)
- 18-month survival rates were 42% with tislelizumab + chemo vs. 33% with chemo alone.
- 24-month survival rates were 33% with tislelizumab + chemo vs. 23% with chemo alone.
TRAEs: Grade 3/4 TRAEs were common in both arms (tislelizumab: 54%, placebo: 50%).
Serious AEs: Occurred in 23% of the tislelizumab arm and 15% of the placebo arm.”