SUNLIGHT
Adding the old blood-vessel antibody to a late-line chemotherapy pill extended survival by three months in patients who had exhausted standard options.
OS 10.8 vs 7.5 months (HR 0.61, NEJM 2023). FDA approval August 2023. Now the preferred third-line option ahead of regorafenib or fruquintinib in many guidelines.
Setting
Refractory metastatic colorectal cancer: trifluridine/tipiracil + bevacizumab vs trifluridine/tipiracil
Phase
Phase 3
Sponsor
Taiho / Servier
Registry
Headline result
OS 10.8 vs 7.5 months, HR 0.61.
Reported
2023
Enrolled
492
Replication
Consistent with the Danish phase 2 (Pfeiffer, Lancet Oncology 2020).
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 10.8 vs 7.5 months with Trifluridine/tipiracil + bevacizumab compared with Trifluridine/tipiracil; about 3.3 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 39 percent lower chance of the event at any given time (hazard ratio 0.61, likely range 0.49 to 0.77).
- 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: Refractory metastatic colorectal cancer: trifluridine/tipiracil + bevacizumab vs trifluridine/tipiracil. 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.
492 participants enrolled.
Overall survivalprimary
HR 0.61 (0.49–0.77)
Trifluridine/tipiracil + bevacizumab
10.8 mo
Trifluridine/tipiracil
7.5 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Trifluridine/tipiracil + bevacizumab | 246 | 10.8 months | 0.61 (0.49–0.77) | — | link |
| Trifluridine/tipiracil | 246 | 7.5 months |
Replication
Consistent with the Danish phase 2 (Pfeiffer, Lancet Oncology 2020).