RATIONALE-302
The global trial in which tislelizumab beat chemotherapy for oesophageal cancer that had progressed after first treatment, which carried it to approval in the US, Europe and Japan.
Overview
512 patients from 11 countries. Median overall survival 8.6 versus 6.3 months (hazard ratio 0.70), with greater benefit at PD-L1 TAP 10% or more (10.3 versus 6.8 months). Because it enrolled outside China it underpinned the EU approval (2023), the first FDA approval of tislelizumab (March 2024) and Japanese approval, in contrast to the China-only PD-1 filings that failed in the US.
- Median 8.6 vs 6.3 months with Tislelizumab compared with Chemotherapy; about 2.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 30 percent lower chance of the event at any given time (hazard ratio 0.7).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Second-line advanced or metastatic oesophageal squamous cell carcinoma, global (Asia, Europe, North America): tislelizumab vs investigator's choice chemotherapy. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Pages like this
not linked directly; found by shared links- PersonJohn Oyler
Shares BeOne Medicines (formerly BeiGene), Tislelizumab and the tag china.
- InstitutionJiangsu Cancer Hospital
Shares Oesophageal cancer and the tag china.
- TrialJUPITER-06
Shares Oesophageal cancer, Immune checkpoint inhibitors and the tag china.
- InstitutionSichuan Cancer Hospital
Shares Oesophageal cancer and the tag china.
- TrialGEMSTONE-302
Shares Immune checkpoint inhibitors and the tag china.
- ProductSintilimab
Shares Oesophageal cancer, Immune checkpoint inhibitors and the tag china.
- TrialCameL
Shares Immune checkpoint inhibitors and the tag china.
- TrialORIENT-11
Shares Immune checkpoint inhibitors and the tag china.