SPOTLIGHT & GLOW
Two trials that made Claudin 18.2 the third biomarker in stomach cancer, adding about two to three months of survival with an antibody against it.
SPOTLIGHT: PFS 10.6 vs 8.7 months, OS 18.2 vs 15.5 months. GLOW: PFS 8.2 vs 6.8, OS 14.4 vs 12.2 months. About 38% of screened patients were CLDN18.2-positive at the ≥75% threshold. FDA approval 18 October 2024 (Vyloy), first CLDN18.2-directed therapy. Nausea and vomiting, on-target from gastric mucosa, are frequent and front-loaded.
Setting
First-line CLDN18.2-positive (≥75% of cells), HER2-negative advanced gastric/GEJ adenocarcinoma: zolbetuximab + mFOLFOX6 (SPOTLIGHT) or CAPOX (GLOW) vs chemotherapy
Phase
Phase 3
Sponsor
Astellas
Registry
Headline result
SPOTLIGHT OS 18.2 vs 15.5 months; GLOW OS 14.4 vs 12.2 months.
Reported
2023
Replication
Two independent phase 3 trials with different chemotherapy backbones agree.
In plain words
What these results mean for people, not percentages
Overall survival (SPOTLIGHT)survival endpoint
- Median 18.2 vs 15.5 months with Zolbetuximab + mFOLFOX6 compared with Placebo + mFOLFOX6; about 2.7 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 (GLOW)survival endpoint
- Median 14.4 vs 12.2 months with Zolbetuximab + CAPOX compared with Placebo + CAPOX; about 2.2 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.
Be careful
- 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 CLDN18.2-positive (≥75% of cells), HER2-negative advanced gastric/GEJ adenocarcinoma: zolbetuximab + mFOLFOX6 (SPOTLIGHT) or CAPOX (GLOW) vs chemotherapy. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (CLDN18.2); the result should not be assumed for people whose cancer does not have it.
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.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (SPOTLIGHT) | Zolbetuximab + mFOLFOX6 | — | 18.2 months | — | — | link |
| Placebo + mFOLFOX6 | — | 15.5 months | ||||
| Overall survival (GLOW) | Zolbetuximab + CAPOX | — | 14.4 months | — | — | link |
| Placebo + CAPOX | — | 12.2 months |
Replication
Two independent phase 3 trials with different chemotherapy backbones agree.