PHAROS
PHAROS showed that the melanoma combination encorafenib and binimetinib shrinks three quarters of untreated BRAF V600E lung cancers and nearly half of previously treated ones, giving a second approved BRAF plus MEK pair for lung cancer.
Overview
PHAROS treated 98 patients with metastatic BRAF V600E-mutant non-small-cell lung cancer with encorafenib 450 mg daily and binimetinib 45 mg twice daily, 59 of them treatment-naive and 39 previously treated. Dabrafenib plus trametinib had been approved for this population in 2017 on a similar single-arm design.
The response rate was 75 percent in treatment-naive patients and 46 percent in previously treated patients, with median durations of response of about 40 months and 16.7 months respectively. Nausea, diarrhoea, fatigue and vomiting were the main side effects; the fever that limits dabrafenib and trametinib was uncommon.
The FDA approved encorafenib with binimetinib for BRAF V600E lung cancer in October 2023. Non-V600 BRAF mutations, about half of BRAF-mutant lung cancers, do not respond to these drugs.
- 75 vs 46 out of 100 had their tumour shrink with Treatment-naive compared with Previously treated; 29 more per 100.
- Roughly one extra person helped for every 3 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Metastatic BRAF V600E-mutant non-small-cell lung cancer, treatment-naive or previously treated: encorafenib plus binimetinib. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (BRAF); the result should not be assumed for people whose cancer does not have it.
- Only 98 people took part, so the numbers are less certain than in a large trial.
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.
98 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate (independent review)primary | Treatment-naive | 59 | 75% | - | - | link |
| Previously treated | 39 | 46% |
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