RATIONALE-306
RATIONALE-306 is the trial behind tislelizumab's US approval for squamous oesophageal cancer, with the biggest gains in PD-L1-positive tumours.
OS 17.2 vs 10.6 months overall (HR 0.66; Lancet Oncology 2023); PD-L1 ≥1%: 16.8 vs 9.6 months. FDA approval 4 March 2025 restricted to PD-L1 ≥1% (TAP). Also approved in EU (2024).
- Median 17.2 vs 10.6 months with Tislelizumab + chemotherapy compared with Placebo + chemotherapy; about 6.6 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 34 percent lower chance of the event at any given time (hazard ratio 0.66).
- Median 16.8 vs 9.6 months with Tislelizumab + chemotherapy compared with Placebo + chemotherapy; about 7.2 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.
- 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: First-line advanced oesophageal squamous cell carcinoma: tislelizumab + platinum chemotherapy vs placebo + 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.
649 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, all patientsprimary | Tislelizumab + chemotherapy | 326 | 17.2 months | 0.66 | — | link |
| Placebo + chemotherapy | 323 | 10.6 months | ||||
| Overall survival, PD-L1 ≥1% | Tislelizumab + chemotherapy | — | 16.8 months | — | — | link |
| Placebo + chemotherapy | — | 9.6 months |
Pages like this
not linked directly; found by shared links- TrialKEYNOTE-590
Shares Oesophageal cancer, PD-1.
- TrialHERIZON-GEA-01
Shares Tislelizumab, Oesophageal cancer, PD-1.
- TrialCheckMate 648
Shares Oesophageal cancer, PD-1.
- PersonShun Lu
Shares Tislelizumab, PD-1.
- TrialESCORT-1st
Shares Oesophageal cancer, PD-1.
- TrialCheckMate 577
Shares Oesophageal cancer, PD-1.
- IdeaBiomarker-directed first-line quadruplets in gastric cancer
Shares Tislelizumab, PD-1.
- PersonYelena Y. Janjigian
Shares Oesophageal cancer, PD-1.