ALTA-1L
ALTA-1L showed that brigatinib more than doubled the time ALK-positive lung cancer stayed under control compared with crizotinib, with strong activity against brain metastases.
Overview
ALTA-1L randomised 275 patients with untreated advanced ALK-positive non-small-cell lung cancer to brigatinib or crizotinib, allowing up to one prior line of chemotherapy. Brigatinib had been approved in 2017 for patients who had progressed on crizotinib.
In the final analysis median progression-free survival by blinded independent review was 24.0 months with brigatinib against 11.1 months with crizotinib (hazard ratio 0.48); among patients with brain metastases at baseline the intracranial response rate was much higher with brigatinib. Early pulmonary events in the first week, seen in a small minority, are the drug's distinctive toxicity and are managed by a lower starting dose.
The FDA approved brigatinib for first-line use in May 2020, giving a third first-line option alongside alectinib and lorlatinib.
- Median 24 vs 11.1 months with Brigatinib compared with Crizotinib; about 12.9 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 52 percent lower chance of the event at any given time (hazard ratio 0.48).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Untreated advanced ALK-positive non-small-cell lung cancer: brigatinib versus crizotinib. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (ALK); 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.
275 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (blinded independent review, final)primary | Brigatinib | 137 | 24 months | 0.48 | - | link |
| Crizotinib | 138 | 11.1 months |
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