FLAURA2
Adding chemotherapy to osimertinib extended both progression-free and, in 2025, overall survival.
PFS 25.5 vs 16.7 months (HR 0.62); OS HR 0.77 (2025).
- Median 25.5 vs 16.7 months with Osimertinib + chemotherapy compared with Osimertinib; about 8.8 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 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.49 to 0.79).
- 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.
- Median 47.5 vs 37.6 months with Osimertinib + chemotherapy compared with Osimertinib; about 9.9 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 23 percent lower chance of the event at any given time (hazard ratio 0.77, likely range 0.61 to 0.96).
- 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 EGFR-mutant NSCLC: osimertinib + chemotherapy vs osimertinib. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (EGFR); 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.
557 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (investigator)primary | Osimertinib + chemotherapy | 279 | 25.5 months | 0.62 (0.49–0.79) | <0.001 | link |
| Osimertinib | 278 | 16.7 months | ||||
| Overall survival | Osimertinib + chemotherapy | — | 47.5 months | 0.77 (0.61–0.96) | 0.02 | link |
| Osimertinib | — | 37.6 months |
Patients newly diagnosed with EGFR-mutated advanced lung cancer now have a first-line option that improves survival over osimertinib, particularly if they have high-risk features. The trade-off is intravenous (now subcutaneous) infusions and considerably more skin, nail and clotting toxicity, so osimertinib alone remains reasonable for those who prioritise convenience and tolerability. Both this regimen and osimertinib plus chemotherapy (FLAURA2) are approved; there is no direct comparison.
Anyone diagnosed with advanced lung cancer should have EGFR testing before treatment, because osimertinib as the first drug gives the longest disease control, protects the brain, and is well tolerated. Chemotherapy is not the first step for these patients. The remaining questions are whether to intensify upfront (adding chemotherapy or amivantamab) and how to treat resistance when it develops.