An updated analysis of the phase III ADAURA trial revealed a median disease-free survival (DFS) of 5.5 years for early-stage, EGFR-positive non-small cell lung cancer (NSCLC) patients who received osimertinib (Tagrisso) in the postoperative setting, with nearly three in four patients treated with the adjuvant therapy free of disease at 4 years.
Results from the study were presented at the annual congress of the European Society for Medical Oncology (ESMO). In this exclusive ѻý video, investigator Roy S. Herbst, MD, PhD, of Yale Cancer Center in New Haven, Connecticut, discusses the impact of the new results.
Following is a transcript of his remarks:
On behalf of our team, Dr. [Masahiro] Tsuboi presented the updated results on ADAURA. And I think after 2 more years of follow-up -- which by the way would've been the original time for analysis, because ADAURA read out so early -- the hazard ratios are still in the 0.2 range, low 0.2 range. I would say that the DFS remains a consistent, positive, highly significant value across all the different subgroups, meaning that if you use osimertinib after chemo in EGFR-mutated patients with stage I-III disease, you prolong disease progression. And I think that's great. And the brain data showed the same thing, hazard ratios a little higher than it was with 2 more years of follow-up, but still it's preventing metastases to the brain at about a 10 to 1 rate.
The only thing I think, honestly, with the trial giving 3 years of drug, the curves do come together a little bit. You would understand that, based on EGFR biology, there are persister cells that survive even under the suppressive effect of Tagrisso. And those probably in some patients, not all, will rear their head when the drug stops.
The elephant in the room is what about survival? I think we'll see survival, I can't predict exactly when, but survival will occur. There's a preset endpoint for events to look at survival. And I would think that would probably happen within the next year. I think with the DFS curves, as we've seen them, it's hard to believe survival won't be positive, but we have to wait for that result. And then of course, further analysis of the data in the brain.
The other thing I'm very excited to think about is the biology behind all this. Can we look at blood tests of those early and late [recurrences], can we tell who was at more risk of recurrence versus not? Someday I think we're going to probably wanna give some people more than 3 years of Tagrisso. And some may be less. And that's gonna mean looking at liquid biopsies, understanding who has tumor cells in their circulation: are they still sensitive to Tagrisso or not?
So a lot still to go on, but I think right now, full speed ahead. We're gonna do an update of this, I'm actually going to Chicago on Saturday to give an update in the , and then stay tuned for survival sometime hopefully soon.