ADAURA
Showed a targeted pill after lung cancer surgery halves the risk of death, the first such result for a targeted therapy.
DFS HR 0.20 (stage II-IIIA); OS HR 0.49 (5-year OS 88% vs 78%).
- Median 19.6 months with Placebo.
- Osimertinib: Median DFS not reached with osimertinib at the primary analysis.
- "Not reached" means that, when the data were analysed, more than half of that group had not yet had the event, which is good news for that group.
- A median is a midpoint: half the people did better than this and half did worse.
- Put another way, the treated group had about 83 percent lower chance of the event at any given time (hazard ratio 0.17, likely range 0.11 to 0.26).
- 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.
- 85 vs 73 out of 100 alive at 5 years with Osimertinib compared with Placebo; 12 more per 100.
- Roughly one extra person helped for every 8 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 51 percent lower chance of the event at any given time (hazard ratio 0.49, likely range 0.33 to 0.73).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 88 vs 78 out of 100 alive at 5 years with Osimertinib compared with Placebo; 10 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 51 percent lower chance of the event at any given time (hazard ratio 0.49, likely range 0.34 to 0.7).
- 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: Adjuvant osimertinib 3 years after resection of stage IB-IIIA EGFR-mutant NSCLC. 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.
682 participants enrolled.
Median DFS not reached with osimertinib at the primary analysis
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival, stage II–IIIAprimary | Osimertinib | 233 | Median DFS not reached with osimertinib at the primary analysis | 0.17 (0.11–0.26) | <0.001 | link |
| Placebo | 237 | 19.6 months | ||||
| Overall survival at 5 years, stage II–IIIA | Osimertinib | — | 85% | 0.49 (0.33–0.73) | <0.001 | link |
| Placebo | — | 73% | ||||
| Overall survival at 5 years, stage IB–IIIA | Osimertinib | — | 88% | 0.49 (0.34–0.7) | — | link |
| Placebo | — | 78% |
Every resected non-squamous lung cancer should be tested for EGFR mutations, because patients who carry one live longer if they take osimertinib for three years after surgery. The trial does not tell us whether adjuvant chemotherapy can be omitted, nor what happens on relapse after osimertinib, and the three-year duration was chosen empirically.
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.
Pages like this
not linked directly; found by shared links- ProductGefitinib
Shares EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), Guangdong Provincial People's Hospital, EGFR, Non-small-cell lung cancer.
- PersonJean-Charles Soria
Shares FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer, Osimertinib, EGFR, Non-small-cell lung cancer.
- ProductErlotinib
Shares EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), Guangdong Provincial People's Hospital, EGFR, Non-small-cell lung cancer.
- TrialFLAURA2
Shares Guangdong Provincial People's Hospital, FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer, Osimertinib, Non-small-cell lung cancer.
- ProductAlectinib
Shares ALINA, Prevention trials aimed only at brain metastasis, Non-small-cell lung cancer.
- ProductSunvozertinib
Shares EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), EGFR, Non-small-cell lung cancer.
- TermSegmentectomy (sublobar resection)
Shares Lobectomy, Non-small-cell lung cancer.
- TrialLAURA
Shares Osimertinib, EGFR, Non-small-cell lung cancer.