Primary endpoint
HR 0.6195% CI 0.49–0.76 · stratified log-rank p < 0.001
Adding arbolitinib to standard care reduced the risk of progression or death by 39 percent. Median progression-free survival was not reached in the treatment arm against 21.4 months in the control arm.
Progression-free survival
Kaplan-Meier, 36 monthsArbolitinib + standard care — 52.9% Standard care — 31.2%
| At risk | 0 | 6 | 12 | 18 | 24 | 30 | 36 |
|---|---|---|---|---|---|---|---|
| Treatment | 428 | 401 | 372 | 339 | 301 | 268 | 241 |
| Control | 431 | 388 | 341 | 294 | 249 | 206 | 171 |
Enrollment
cumulative, 30 months- Randomised
- 859
- Sites
- 74
- Screen failure
- 18.2%
- Withdrawn
- 41
- Follow-up (median)
- 28.6 mo
Enrollment closed four months ahead of plan. The flattening after month twenty is the cap, not a recruitment failure.
Baseline
balance across arms| Characteristic | Treatment | Control |
|---|---|---|
| Median age | 64 | 63 |
| Female | 46.0% | 45.5% |
| Stage III | 54.9% | 54.5% |
| ECOG 0 | 61.2% | 60.3% |
| Prior lines (median) | 1 | 1 |
Randomisation balanced the arms on every stratification factor, so the hazard ratio does not need adjusting to be read.
Subgroup analysis
hazard ratio with 95% confidence intervalEvery interval sits left of 1.0, so no subgroup contradicts the overall result. Stage II is the widest and the closest to crossing; it is also the smallest stratum, which is the usual explanation.
Adverse events
treatment arm, by CTCAE grade| Event | Share of participants | G1 | G2 | G3 | G4 |
|---|---|---|---|---|---|
| Neutropenia | 18 | 11 | 6 | 1 | |
| Fatigue | 34 | 14 | 3 | — | |
| Nausea | 29 | 9 | 2 | — | |
| Rash | 16 | 6 | 1 | — | |
| Neuropathy | 12 | 7 | 3 | — | |
| Anaemia | 14 | 8 | 4 | 1 |
Grade 1Grade 2 Grade 3Grade 4
Grade 3 and 4 events are the right-hand end of each bar. Neutropenia is the only event where they exceed five percent, and it is managed by dose delay.