Medicine Matters oncology

So BIONIKK is a randomized phase 2 trial on kidney cancer, metastatic kidney cancer, first-line treatment. It's a French academic trial. And in this trial, we randomized patients according to their molecular group. Previously, we identified patients treated with sunitinib in four distinct molecular groups. And given their immunofiltration and their response to sunitinib, we designed the BIONIKK trial.

Briefly, patients were not previously pre-treated, were molecularly grouped in a reference platform between 1, 2, 3, and 4. Patients with groups 1 and 4 were randomized between nivolumab and ipilimumab. And patients with groups 2 and 3 were randomized between nivolumab, ipilimumab, and TKI.

So the main results of the BIONIKK study, this clinical part, was that we found the group 4 with IO-based treatment performed very well, particularly nivolumab, with 50% of objective response rate, which is quite high. And group 2, where TKI performed very well, with more than 50% of objective response rates.

So we identify patients, the best candidates for each treatment arm. And besides that, we have a huge ancillary translational program which is currently ongoing, including transcriptomic analysis on the frozen tumor samples, on FFP archived tumor samples, an artificial intelligence program on FFP slides, as well as a huge program on separating biomarkers, including immunophenotyping. So we hope to see this as a result probably next year. And for now, we already identified the best candidate to receive this treatment, nivolumab, nivolumab- ipilimumab, or TKI.

It's a signature used in BIONIKK. I didn't mention that we used a 35 gene signature, and based on frozen tumor sample. That's something very important, because it's difficult right now to get frozen samples from patients in our daily routine. So we can not extrapolate and we cannot use it right now for our patients.

This trial is a first step and the high number of ancillary projects in this trial I think will answer many questions. And how can we recapitulate this molecular group? For example, by immunohistochemistry, we have nearly 15 markers, which are currently ongoing.

And are we able to recapitulate this molecular group by very simple markers such as immunohistochemistry? And can we perform this signature on paraffin embedded tumor samples? This is a key question that we are currently addressing.

And regarding these results, we will see if we are able to extrapolate and to use it in the clinic. It is too early right now. This is the first, preliminary data. And so we have to improve our data.