Tislelizumab (5) – Tevimbra®

• Clinical trials
  • The RATIONALE 306 trial is a double-blind Phase III trial comparing tislelizumab in combination with platinum-based chemotherapy against placebo in combination with platinum-based chemotherapy (hereinafter: chemotherapy).

a) Adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus that is not amenable to curative treatment, whose tumours exhibit PD-L1 expression with a TAP score of ≥ 5 per cent and, in addition, tumour cellPD-L1 expression of ≥ 1 % or a Combined Positive Score (CPS) of ≥ 10; first-line treatment

• The additional benefit is not proven.
• No data were available for the benefit assessment in comparison with the appropriate comparator therapy.

b) Adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus that is not amenable to curative treatment, whose tumours exhibit PD-L1 expression with a TAP score of ≥ 5 % and, in addition, no tumour cellPD-L1 expression of ≥ 1% and no Combined Positive Score (CPS) of ≥ 10; first-line treatment

• An additional benefit is not proven.
• There are therefore no suitable data available to assess the additional benefit of tislelizumab in combination with platinum-based chemotherapy compared with the appropriate comparator therapy.
• In particular, due to the failure to take into account the tumour cell PD-L1 expression characteristic, the patient population from the RATIONALE 306 study submitted by the pharmaceutical manufacturer cannot be used for the benefit assessment.

Courtesy translation only, please refer to the German original.