"The median survival of the combination arm was 16.1 months versus 13.4 months in the standard chemo arm," says Enrique Grande, MD.
In this video, Enrique Grande, MD, discusses findings from the IMvigor130 trial, which were presented at the 2023 ASCO Genitourinary Cancers Symposium in San Francisco, California. Grande is a medical oncologist at MD Anderson Cancer Center in Madrid, Spain.
IMvigor130 was a phase 3 trial in first-line metastatic urothelial carcinoma, that were risk stratified according to the expression of PD-L1 according to the binary and risk factors, and according to the investigator choice of chemotherapy. Patients were randomized into one of these 3 arms. Arm A was those patients who received gemcitabine or gemcitabine plus carboplatin plus atezolizumab with a PD-L1 inhibitor. Arm B, those patients who receive singular atezolizumab. And Arm C, those patients who receive gemcitabine plus carboplatin or gemcitabine plus placebo, that was the comparator arm.
There were 2 co-primary end points and there was a hierarchy, a statistical design here, progression free survival according to the investigator, and overall survival, this is objective according to the investigator, of overall survival for those patients who were treated with the combination that should be a standard chemotherapy arm.
I was lucky and fortunate to present on behalf of the rest of the investigators the results of a combination arm versus a standard chemo arm. The final OS analysis was released here at this ASCO GU 2023. Unfortunately, the hazard ratio was 0.85, not statistically significant. The P value was 0.023, and unfortunately, it didn't meet the P boundary threshold for statistical significance of 0.021.
Despite of that, numerically speaking, the median survival of the combination arm was 16.1 months versus 13.4 months in the standard chemo arm. I think it is relevant from the clinical perspective that the last patient was recruited for 18 months after the analysis was performed. At that time, while 24% of the patients were still alive in the combination arm. This threshold of long-lasting activity I think this is clinically relevant and important. In addition to these findings, and I think also relevant, the group analysis of those patients treated with gemcitabine plus atezolizumab was better than gemcitabine alone, particularly when we compare with the data with carboplatin plus gemcitabine plus atezolizumab, which did not really observe any significant relevance difference in between the 2 arms.
This is because of the immunogenicity induced by cisplatin and not by carboplatin. While there is a huge molecular effort in terms of trying to see what is the translation behind this data, trying to see the molecular background behind this more immunogenicity that cisplatin may induce instead of carboplatin.
Another relevant finding from this group analysis or from this trial, is that unfortunately, the combination is not really helping us to make that more patients are not relapsing or not progressing as best response than when we were using chemotherapy alone.
This transcription was edited for clarity.