Updated Data From the Phase 2 BIONIKK Trial in RCC


Yann-Alexandre Vano, MD, discusses the main findings from the phase 2 BIONIKK trial that were presented at the 2023 Genitourinary Cancers Symposium.

Yann-Alexandre Vano, MD, Georges-Pompidou European Hospital, Paris, France, discusses the main findings from the phase 2 BIONIKK trial (NCT02960906) that were presented at the 2023 Genitourinary Cancers Symposium.

In the phase 2 BIONIKK trial, 199 patients with metastatic renal cell carcinoma (RCC) were randomized to receive nivolumab (Opdivo; n = 58), nivolumab and ipilimumab (Yervoy; n = 101), or an or anti-VEGFR tyrosine kinase inhibitor (TKI; n = 40) in the frontline.

Some of the findings reported by Vano showed that at a median follow-up of 42.1 months, the median overall survival was 43.4 months in the nivolumab arm (95% CI, 31.4-not reached [NR]), 52.7 months with nivolumab and ipilimumab (95% CI, 46-NR), and 38.1 months (95% CI, 33.2-NR) with TKI. A total of 86 patients (43%) died, including 27 given nivolumab (46.5%), 39 given nivolumab and ipilimumab (39%), and 20 (50%) with TKI.

Using the full findings from the trial, experts will be able to better assist when providing recommendations on the best treatment sequence in the first-line and second-line settings for patients with RCC.


0:08 | The main findings discussed the overall survival. At the time of the publication last year, we had a median follow-up of 18 months. So, we had only 20% appearance. Now with mature data, we have over 43% appearance. If we look at overall survival by treatment arm, the median was not reached with nivolumab/ipilimumab, and it was 35 months with nivolumab, clearly inferior to nivolumab/ipilimumab. It was 45 months with VEGFR TKI, which is quite high.

0:39 | When we look at it by moleculer group tumor, we saw that in group 1, nivolumab/ipilimumab provided a higher overall survival, 45 months for nivolumab/ipilimumab and 35 months for nivolumab alone. In group 4, the difference is bigger. With nivolumab/ipilimumab the median OS was not reached and was 35 again for nivolumab alone, and in group 2, this particular group that was sensitive to VEGFR TKI, both treatment arms, TKI and nivolumab/ipilimumab, the median was not reached, and the curve looked like very similar. That's the first result.

1:29 | The second result is the update of overall response rate. Again, we showed that nivolumab/ipilimumab provided a higher response rate in group 4, better than nivolumab, where we reached 55% objective response
and in group 2, we had a high response rate, almost the same, at 54% with nivolumab/ipilimumab, and 58% with VEGFR TKI. Again, we confirmed that VEGFR TKI is a very effective treatment in ccrcc2, and nivolumab/ipilimumab is very effective in ccrcc4, but also in ccrcc2.

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