EU backs Tevimbra's stomach restriction – and then some

While BeiGene awaits US Tevimbra approvals for front-line oesophageal squamous cell and gastric/gastroesophageal junction cancers, it has a pretty good idea that the FDA will limit these to PD-L1-expressing patients. That view has been more than endorsed by the EU regulator, which has just greenlit Tevimbra chemo combos in these two settings, backed by the Rationale-306 and 305 trials respectively, in patients whose cancers express PD-L1 with a tumour area positivity (TAP) score of ≥5%. The precise PD-L1 cutoff the FDA will apply is unknown. The issue was debated at length during a September adcom, as a result of which Tevimbra missed its July 2024 PDUFA date for the Rationale-306 indication (the other use has a December 2024 PDUFA date). The adcom's upshot was that PD-(L)1 drug approvals in these cancers should be restricted to PD-L1-expressers – but at 1% rather than the 5% the EMA has opted for. Matters aren't helped by the fact that Rationale-306 subgroup data provided analysis for neither cutoff, but rather for ≥10% PD-L1 expression. And, to complicate things further, TAP is just one of three PD-L1 scoring methods being used, with no agreement on future uniformity.

Selected Tevimbra + chemo approvals

Source: OncologyPipeline.