As you know, lung cancer is the most common, or one of the most common, cancers in the world and a killer cancer, the first course of cancer. Due to the different advances we have the possibility to identify a subset of patients in which we offer a different option of treatment, particularly in patients with advanced disease. In this particular setting, the setting of patients with EGFR mutation, it’s true that this was the first predictive biomarker identified in this population. The number of patients with EGFR mutation varies according to, for instance, the region – in Europe in the Caucasian population it’s about 10-15% of patients while in some Asian countries the prevalence is close to 40%. So the relevance of these data are different depending on the population you are treating usually, but they are really relevant.
We demonstrated several years ago that using an oral drug, an oral TKI, instead of chemotherapy offered better results, better outcomes for patients in terms of quality of life, response, duration of response, progression free survival. According to all the guidelines the EGFR TKIs are the standard of care. We have first generation agents, erlotinib and gefitinib, second generation agents, afatinib and dacomitinib, and third generation agents – the newest one osimertinib.
This study was focussed on a face-to-face comparison between first generation versus third generation agents. The primary endpoint of the study was progression free survival, Dr Ramalingam mentioned, and this primary endpoint was met. The study was published and osimertinib is already one option of treatment for patients in some countries in the first line setting. But for clinicians, for patients and also for our health authorities the results in terms of overall survival are really relevant. This is why this study is also important now in this secondary endpoint from the statistical point of view.
The study is statistically significant and clinically relevant. It means that even having a longer exposure to the drug no new safety events have been shown; that is relevant for our patients. According to the course, more than 50% of patients located to osimertinib are still alive after a year and this is clinically relevant. So osimertinib demonstrated benefit in terms of progression free survival, safety profile, a very good safety profile, good penetration CNS and now more than six months of median survival time difference in comparison to the first generation agent. So these results are relevant.
The key point, apart from discussing the next step, how can we improve survival in coming years for this population that, of course, is really relevant for us, the key points are firstly we need to be sure that all patients are tested to look at the possibility of having an EGFR mutation. So a biomarker test is clearly relevant and, of course, to be sure that we can offer this kind of agent to our patients. We need to be sure that we can offer TKIs and probably osimertinib as the best one in the first line setting. This is my comment, thank you.