Medicine Matters oncology

So during the 2020 virtual ASCO, I had the honor, my co-investigators and I, to present results from a FRACTION-RCC-- 46 patients treated with nivolumab/ipilimumab but after immune checkpoint inhibitor.

So first, just let's take a seat back, talk about this FRACTION program-- very interesting program out of Bristol-Myers Squibb that looks at the patients that are I-O-- Immuno-Oncology-- drugs naive or experienced and try to test, let's say, with a backbone nivolumab the PD-1 inhibitor, several assets-- let's say several immuno-oncology assets-- fast, so to pick the winner. So based on the whole program, this program also done in lung cancer and kidney cancer. It's done-- we zeroed on I-O experienced 46 patients with nivolumab and the other asset ipilimumab, the CTLA-4 inhibitor.

Interesting enough, this is important because the combination of nivolumab/ipilimumab has shown to prolong survival versus sunitinib in untreated patient. We really do not have prospective data out of a trial from patient who has been I-O experienced in kidney cancer-- so someone that end up progressing on pembrolizumab/axitinib, avelumab/axitinib, someone that has sunitinib followed by nivolumab followed by cabozantinib-- then they would like to do an immune checkpoint inhibitor. What's the data for nivolumab/ipilimumab, which has significant presence in untreated patient?

So we treated 46 patients. The response rates were 15%. These are, you know, RECIST defined response rate, 15%. So this is different. We also did not see a complete response. So this is different from the data in untreated patients overall, where we see 10%, 11% response rate-- sorry, complete responses, and 42% overall response rate by result. Here we saw 15%, but that's important in a subset of patients, you know, who had prior immune checkpoint inhibitor.

The good thing is that the toxicity was manageable. And perhaps in part that these patient are I-O experienced-- so we didn't enroll anyone-- we didn't enroll in anyone that had bad immune related side effects, severe immune related side effects, in the past. So this was actually manageable.

These responses were good responses. Median duration of response was not reached. So that, I think, is important, you know, overall for that-- to have that gap, you know, answered. These are all, just to let you know, clear cell-- the patient with renal cell with a clear cell component. Thank you.