TEVIMBRA (tislélizumab) - Metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma

The clinical benefit of TEVIMBRA (tislelizumab) 100 mg concentrate for solution for infusion is substantial in the two MA indication extensions.

Considering:

• evidence of superiority in a randomised comparative study (RATIONALE 305) of TEVIMBRA plus chemotherapy compared to chemotherapy alone in the PD-L1 ≥ 5% population (population of the MA) in terms of overall survival; a stratified HR of 0.74 CI95%: [0.59, 0.94], was demonstrated, with a median OS of 17.2 months versus 12.6 months in the chemotherapy group,
• a superiority compared to chemotherapy alone in the ITT population in terms of overall survival, with a stratified HR of 0.80 CI95%: [0.70, 0.92],
• a superiority for progression-free survival (ranked endpoint) with a stratified HR of 0.67 [0.55, 0.83] in the ITT population,
• exploratory data relative to quality of life,
• the safety profile, marked by immune-mediated adverse effects (primarily dysthyroidism),

the Transparency Committee considers that TEVIMBRA (tislelizumab) in combination with platinum and fluoropyrimidine-based chemotherapy, provides a moderate clinical added value (CAV III) compared to chemotherapy alone, in the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5%.