We are presenting at the plenary session of the ESMO 2019 the results of the IMvigor130 trial. The IMvigor130 trial is the largest trial ever conducted, ever reported, in the field of metastatic urothelial tumours. We randomised patients in first line with metastatic urothelial carcinoma to one of these three arms – chemotherapy as a control arm, the combination of chemotherapy plus atezolizumab, a PD-L1 inhibitor, or atezolizumab as a single agent. Patients were stratified according to the PD-L1 status, according to the Bajorin risk factors group and also according to the investigator choice of chemotherapy. Because the investigators decided if the patients received cisplatin plus gemcitabine or carboplatin plus gemcitabine. The primary endpoints of the trial were progression free survival and overall survival in between the combination arm versus the standard chemotherapy arm and overall survival between the monotherapy arm with atezolizumab versus the standard chemotherapy arm.
The IMvigor130 trial met the primary endpoint of progression free survival with a hazard ratio of 0.82. The combination arm did better in terms of progression free survival than the standard chemotherapy arm. This is the first time that happens in a phase III randomised fashion that any combination or any drug is improving the activity versus cisplatin-based chemotherapy. In addition to the data that we have with the progression free survival the IMvigor130 trial is showing a promising but not a statistically significant trend to improve the overall survival which I think is important.
For the practice-changing of this trial I would suggest to take a look in depth to the subgroup of patients overexpressing PD-L1. When you are treating these patients in the monotherapy arm with atezolizumab as a single agent, it seems with a hazard ratio of 0.68 that the overall survival could be better than with chemotherapy. So I think it merits to test for PD-L1 status for all our patients, regardless if they are cis eligible or ineligible in clinical practice because maybe we should start to consider atezolizumab monotherapy as one treatment option for them.
The conclusions for the IMvigor130 trial is that we have a new player in the field of urothelial carcinoma. Atezolizumab either alone or in combination with chemotherapy may have a role and the challenge that we have is to select these patients – who are the patients that are going to benefit more from this combination or from this monotherapy strategy. I’m pretty convinced that we will have a lot of debate about the clinical utility of this trial, about what the additive effect of atezolizumab to the combination can offer and, of course, the quality of life of patients treated in the monotherapy arm.