Roy Herbst, MD, PhD, FACP, FASCO, Yale University, New Haven, CT, updates us on the ADAURA study (NCT02511106), evaluating osimertinib adjuvant therapy in patients with resected EGFR mutated non-small cell lung cancer (NSCLC). Prof. Herbst discusses is the incidence of central nervous system (CNS) disease recurrence in patients. The study showed a clinically clinically meaningful improvement in CNS disease-free survival (DFS) with osimertinib: 82% reduction in risk of CNS disease recurrence or death. This interview was recorded via an online conference call with The Video Journal of Oncology (VJOncology).
Transcript (edited for clarity)
We’re so excited that the ADAURA study was presented at ESMO with the paper coming out in the New England Journal of Medicine. Dr. Subai on behalf of all the authors presenting an update of the data, showing as we saw at ASCO that for the primary endpoint. Patients with stage two and three disease who have completely resected tumors, the adjuvant osimertinib had a hazard ratio of 0...
We’re so excited that the ADAURA study was presented at ESMO with the paper coming out in the New England Journal of Medicine. Dr. Subai on behalf of all the authors presenting an update of the data, showing as we saw at ASCO that for the primary endpoint. Patients with stage two and three disease who have completely resected tumors, the adjuvant osimertinib had a hazard ratio of 0.17. And then in the secondary population, adding back the stage 1B patients actually the hazard ratio was even lower this time, 0.20. So even with more follow-up, the results continue to hold 80 plus percent improvement in disease-free survival. Other things that we’ve shown at the meeting where the local regional and metastatic sites of recurrence and one thing that was quite impressive was recurrence in the brain at the time. At the two years, 98% of patients who had osimertinib were disease-free in the brain, whereas only about 85% of patients on the placebo arm were free of brain metastasis.
So hazard ratio of 0.18, so a 92% improvement in preventing a recurrence to the brain. I think that this is another nail in the top of this data set, it really shows that not only do we improve disease-free survival, but we also improve morbidity because we keep patients from developing metastasis in such sensitive sites as the brain. This is very important and right now the ADAURA study will continue on to look at the other important secondary endpoints including survival.
That’s ongoing right now, patients remain blinded at the level of their drug, so we have many patients still on study. We’re following those data, and it’ll be interesting to see that in the future. But in the meantime, the disease-free survival being so dramatic along with the improvement in such a difficult to treat areas such as the brain, I think speaks that these are practice-changing data. Additionally, we’ve collected samples of blood and we’re going to be able to look at cell-free DNA and better understand mechanisms of resistance as well. Very compelling data and it’s great that we were able to present it again at another wonderful virtual meeting, the ESMO virtual meeting.