A phase I/II study of nivolumab and axitinib in patients with advanced renal cell carcinoma.

• DOI: 10.1200/jco.2022.40.6_suppl.291
• Publication Date: 2022-02-16T21:35:25Z
• Authors: Matthew R. Zibelman; Michael Anthony C...; Yasser Ged; Ana M. Molina; Rahul Ravilla; David R. Shaffer; Courtney Lambert; Mahvish Tafseer; Rachel Basiura; Danielle Weismann; Rutika Kokate; Karthik Devarajan; Karen Ruth; R. Katherine Alpaugh; Fern Anari; Pooja Ghatalia; Daniel M. Geynisman; Elizabeth R. Plimack
• Keywords: Axitinib; Clinical endpoint

291 Background: Combination systemic therapy with tyrosine kinase inhibitors (TKIs) and an immune checkpoint inhibitor (IO) are established standard of care for patients metastatic renal cell carcinoma (mRCC). We performed a phase I/II study to investigate the safety efficacy combining TKI axitinib (axi) IO agent nivolumab (nivo). Methods: This investigated combination axi nivo in initial dose finding I portion 3+3 design determine recommended 2 (RP2D) axi. The II included parallel arms: treatment naïve mRCC previously treated TKIs alone or IO/IO (NCT03172754). presenting results from arm only. Included had have histology any clear component, ECOG performance status 0-1, no known symptomatic brain metastases, history autoimmune disease. RP2D was 5 mg BID could be up years. primary endpoint objective response rate (ORR) per investigator assessment. Results: Forty-four were accrued arm. One withdrew consent replaced but is analysis, while 42 evaluable efficacy. median age 65 yrs (range: 42-84 yrs) group predominantly male (83.7%) white (95.3%). Using IMDC risk grading, 18 (41.9%) favorable risk, 22 (51.2%) intermediate 3 (7 %) poor risk. Median follow-up 11.5 months. Best data shown table notable ORR 69.0%, only 1 patient (2.4%) experiencing progressive disease, disease control 97.6%. progression free survival 16.4 months (95% CI: 10.6 - 21.9 mo), overall (OS) not reached. OS at 12 86.7%. Adverse event (AE) similar published IO/TKI combinations, grade 4-5 AEs. Twenty-nine experienced AE (70.7%), most common which hypertension, 14.0% discontinued due treatment-related toxicity. Conclusions: axi/nivo demonstrated comparable available combinations profile. Clinical trial information: NCT03172754. [Table: see text]