Comparing BIONIKK Data of Nivolumab With/Without Ipilimumab in mRCC

Yann-Alexandre Vano, MD, Georges-Pompidou European Hospital, Paris, France, explains some of the findings from the phase 2 BIONIKK trial (NCT02960906) which evaluated nivolumab (Opdivo) and ipilimumab (Yervoy) in metastatic renal cell carcinoma (RCC).

Vano explains some of the findings and demonstrates the feasibility of a prospective patient selection based on tumor molecular phenotype to determine what the most effective treatments for first-line RCC is when comparing nivolumab with or without ipilimumab and a VEGFR-tyrosine kinase inhibitor (TKI).

Transcription:

0:08 | The second part is treatment progression because we recorded the second-line treatment after progression. Nearly 67% of patients receive the second-line treatment and almost all 80% of these patients received the TKI, which is quite interesting to look at because most of these TKI’s are cabozantinib in 54% of the patients, which is the most effective TKI in the second-line or later. We see that the efficacy of the TKI seems to be higher plus nivolumab and ipilimumab in group 4 vs with nivolumab alone with a 33% objective response rate plus nivo/ipi in group 4, and an 11% response rate with nivo in group 4.

0:56 | So clearly there are some things that happened with nivolumab and ipilimumab with the TKI, particularly in group 4. In group 1, we had the same results. The median PFS was also consistent with a higher median PFS post nivo/ipi group for nearly 12 months vs 8 or 9 months in group 4. For group 2, the TKI plus TKI performed extremely well with more than 60% objective response rate, and the TKI plus nivolumab and ipilimumab group performed extremely well, also with a very high response rate and median PFS are nearly 12 months.

1:42 | These results suggest that the second-line is influenced or impacted by the first-line treatments and by the molecular group defined at the beginning. These are hypothesis generating data, but it demonstrates the feasibility of these kinds of biomarker driven trials and it opens a new way to think about new designs with biomarker-based clinical trials.