BIONIKK Trial: Second-line Efficacy, Survival Results

Updated overall survival (OS) and efficacy results of second-line treatment in patients with metastatic renal cell carcinoma (mRCC) treated in the randomized, phase 2 BIONIKK trial were presented at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium.

To date, no biomarker or efficacy data on nivolumab plus ipilimumab or anti-vascular endothelial growth factor tyrosine kinase inhibitor (TKI) have been prospectively validated in mRCC. BIONIKK—a French, multicenter, noncomparative, phase 2 trial—showed promising objective response rate (ORR) and progression-free survival (PFS) with these treatments in the first line after selection by tumor molecular group (clear cell RCC 1-4). In the study, 199 patients with mRCC were randomized to receive nivolumab (n=58), nivolumab plus ipilimumab (n=101), or TKI (N=40) as first-line treatment.

Yann-Alexandre Vano, MD, PhD, and colleagues reported on OS from randomization and from the start of second-line treatment, as well as ORR and PFS with a TKI in second-line treatment by molecular group. The additional follow-up time from the first-line results was at least 20 months.

After a median follow-up of 42.1 months, 43% (n=86) of patients died: 46.5% (n=27), 39% (n=39), and 50% (n=20) in the nivolumab, nivolumab plus ipilimumab, and TKI arms, respectively. Median OS was 43.4 months (95% CI, 31.4-not reached), 52.7 months (95% CI, 46-not reached), and 38.1 months (95% CI, 33.2-not reached), respectively.

Researchers noted the most frequent second-line treatment after nivolumab or nivolumab plus ipilimumab was a TKI, including cabozantinib, sunitinib, pazopanib, axitinib, and lenvatinib. Nivolumab was the most frequent second-line treatment after TKI.

ORR with second-line TKI was 28.5% after nivolumab, 39% after nivolumab plus ipilimumab, and 80% after TKI. Median PFS with second-line TKI was 8.2 months, 11.4 months, and 12.1 months, respectively.

Conversely, ORR and median PFS with second-line nivolumab after TKI was 12.5% and 5.4 months, respectively.

“These results, together with those reported in [first-line treatment], can inform clinicians on the best treatment sequence in [the first and second lines],” researchers concluded.