China-based development of PD(L)1 inhibitors grows in importance

Last week FDA approved Tislelizumab (Tevimbra), a PD-1 blocker made by BeiGene (now solely owned after returning rights from Novartis) for the treatment of unresectable or metastatic esophageal squamous cell carcinoma (ESCC) in patients that received prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. This is an important update for patients with ESCC and it is second China-made PD-1 inhibitor following following Junshi and Coherus’ Toripalimab (Loqtorzi), which was the first China-made PD-1 to gain FDA acceptance for the treatment of nasopharyngeal carcinoma?in the 1st and 2nd line.

Few things to highlight about Tevimbra approval that was based on results of the RATIONALE 302 trial. Although study had heavy Asian participation (79% of patients were in Asian countries) it was deemed sufficiently representative of diverse population (remaining 21% of patients were in EU and North America out of total 512 patients). Results for overall survival (OS) support Tevimbra use as a monotherapy in PDL-1 unselected population which is similar to indication approved for Opdivo and in contrast to Keytruda that is indicated for patients with PD-L1 expression of CPS ≥10.

While recent news evaluating China Biotech focuses on innovation around ADCs, inroads from China-based development within PD(L)1 inhibitors are likely to have greater impact upon treatment landscape in the US and globally considering number of indications leading products Keytruda and Opdivo currently have. Tevimbra already has 11 approvals in China and its sales grew by 27% year over year in 2023 to reach $537 million in 2023. BeiGene?has launched more than 17 potentially registration-enabling trials with Tevimbra, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.?For the frontline treatment of unresectable, recurrent, locally advanced, or metastatic ESCC the FDA is already reviewing a BLA for Tevimbra with a target action date in July 2024.

Tevimbra launch in the US is expected in the second half of 2024 thus it may come after approval in the ESCC 2+ line achieved last week and potential 1st line reached in July 2024. Also, BeiGene hasn’t launched the drug in Europe yet although it received EU approval last September for the same as ESCC indication as it waits for a final European Commission approval for three NSCLC indications.

How much access at the beadside in the US and EU Tevimbra reaches will be of high importance to patients considering both expanded treatment options and potentially favorable financial implications considering that Cohetus prices Loqtorzi at 20% discount to Keytruda. Considering large medical need all these events are certain to be highly followed by medical, patient and coverage communities.

https://ir.beigene.com/news/beigene-receives-fda-approval-for-tevimbra-for-the-treatment-of-advanced-or-metastatic-esophageal-squamous/20eb032c-15ce-456a-a852-39c88a28d811/