"The main highlight of this trial was the complete response rate, which was around 22%," says , Guru P. Sonpavde, MD.
In this video, Guru P. Sonpavde, MD, highlights findings from the phase 3 CheckMate 901 trial (NCT03036098) in patients with metastatic urothelial carcinoma, which were presented at the 2023 European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain. Sonpavde is the GU oncology director at AdventHealth Cancer Institute and a professor of medicine at the University of Central Florida in Orlando, Florida.
The Checkmate 901 trial looked at the combination of gemcitabine/cisplatin plus nivolumab. So, this is a trial dedicated to cisplatin eligible patients. This trial is positive overall. [There were] 608 patients randomized 1:1. As you may have seen, the survival and PFS both improved with a hazard ratio 0.78 and 0.72. The main highlight of this trial was the complete response rate, which was around 22%. Especially the duration or complete response was very long, the median duration of 37 months is more than 3 years, which is very impressive.
I wanted to highlight that this regimen is a regimen in which the cisplatin/gemcitabine goes up to 6 cycles and then stops. Then the nivolumab continues until progression or toxicities. There was a limit of 2 years of nivolumab. What this means is the patient's quality of life is much better after the chemotherapy stops. There is this difference in the way it is given compared to the EV pembrolizumab regimen where EV and pembrolizumab both continue until toxicity or progression. Stopping for neuropathy is a frequent event in the setting of EV pembrolizumab, which overall, of course, is a great advance. But I did want to highlight this.
One of the things is given that the CR is very impressive in gem-cis-nivo and we have this quality of life benefits and the finite duration of chemotherapy, we might want to consider a role for gem-cis-nivo in patients who have lymph node only disease perhaps as 1 group, because we know that this group has a higher CR rate with the cisplatin based chemotherapy. So, could we select gem-cis-nivo in patients with lymph node only disease? Could we identify a biomarker which predicts for better response to cisplatin-based chemotherapy? One that comes to mind is the ERCC2, which has been validated in the neoadjuvant setting to correlate very strongly with pathologic complete remission. This needs more work in the metastatic disease setting. But I think that lymph node only disease, maybe with the help of a biomarker, maybe some other markers, which could be looked at in the Checkmate 901 trial to identify the group of patients who has a high chance of enjoying CR. And the CRs, to remind you, were very durable, the median duration of 37 months. I think they could still be a role for the CheckMate 901 regimen despite the arrival of EV pembrolizumab, which clearly is an impressive regimen with a high CR rate, 29%. The median survival of 31.5 months. I would say that even in this context, the gem-cis-nivo regimen could play a role.
Also remember that in terms of societal costs, the gem-cis-nivo regimen is much cheaper, obviously, because cisplatin/gemcitabine is available much more cheaply, and there is a finite duration of cisplatin/gemcitabine in this CheckMate 901 regimen.
This transcription has been edited for clarity.