Tislelizumab (6) – Tevimbra®

• Clinical trials
  • The completed, double-blind Phase IIIRCT RATIONALE 305, patients with locally advanced, unresectable or metastatic HER-2-negative adenocarcinoma of the stomach or the gastro-oesophageal junction, whose disease had not previously been treated with systemic therapy, were enrolled.
  • As first-line treatment, 501 patients received tislelizumab and 496 patients received a placebo – each in combination with platinum- and fluoropyrimidine-based chemotherapy consisting of either oxaliplatin and capecitabine or cisplatin and 5-fluorouracil.

Adults with locally advanced, unresectable or metastatic HER2-negative adenocarcinoma of the stomach or the gastro-oesophageal junction with tumour PD-L1 expression of ≥ 5 % (Tumour Area Positivity; TAP score); first-line treatment

• The additional benefit is not proven.
• As the data submitted do not allow for a comparison with the appropriate comparator therapy, no evaluable data are available.
• Consequently, the G-BA concludes that, for tislelizumab in combination with platinum- and fluoropyrimidine--based chemotherapy for the first-line treatment of locally advanced, unresectable or metastatic HER-2-negative adenocarcinoma of the stomach or the gastro-oesophageal junction (G/GEJ) in adult patients whose tumours exhibit PD-L1 expression with a TAP score (Tumour Area Positivity) of ≥ 5 per cent, an additional benefit is not proven.
• Conclusion
  • Consequently, the G-BA concludes that no additional benefit is proven for tislelizumab in combination with platinum- and fluoropyrimidine-based chemotherapy.

Courtesy translation only, please refer to the German original.