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ASCO 2021

ASCO 2021: Association of C-Reactive Protein With Efficacy of Avelumab + Axitinib in Advanced Renal Cell Carcinoma: Long-Term Follow-Up Results From JAVELIN Renal 101

(UroToday.com)  There have been transformational changes in first-line therapy for patients with advanced renal cell carcinoma (RCC) in the past three years. Foremost among these is the move from monotherapy to combination approaches. While CheckMate 214 first brought combination therapy with dual checkpoint inhibition to the forefront, subsequent studies have examined combinations of immune checkpoint inhibitors and tyrosine-kinase inhibitors in the first-line setting. One such study was the phase 3 JAVELIN Renal 101 trial (NCT02684006), which demonstrated improvements in progression-free survival and increased objective response rates for patients treated with avelumab and axitinib compared to sunitinib. In the Kidney and Bladder Poster session at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, Dr. Tomita presented data from the JAVELIN Renal 101 trial assessing the association of C-reactive protein (CRP) levels at baseline and early after treatment with the efficacy of avelumab and axitinib compared to sunitinib.

To briefly summarize as JAVELIN Renal 101 has previously been presented and published, this trial accrued patients with advanced renal cell carcinoma and randomized them in a 1:1 fashion to avelumab and axitinib or sunitinib. In addition to clinical outcomes, blood samples were taken for biomarker analysis. Specifically focusing on CRP, levels were assessed at screening and day 1 of each 6-week cycle. Patients were categorized into three groups on the basis of CRP levels: CRP normal (baseline CRP < 10 mg/L), normalized (baseline CRP ≥10 mg/L and ≥1 CRP value decreased to < 10 mg/L during 6 weeks of treatment), and non-normalized (CRP ≥10 mg/L at baseline and during 6 weeks of treatment). The authors used multivariable regression models to assess the association between CRP with efficacy outcomes including progression-free survival (PFS), best overall response per independent central review (RECIST 1.1), and overall survival.

The minimum follow-up for progression-free survival and objective response rate was 13 months while for overall survival was 28 months. In analyses stratified by treatment approach (avelumab and axitinib or sunitinib), the authors demonstrated that PFS and OS were consistently higher among those in both the normal and normalized groups compared with the non-normalized group.

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Among patients treated with avelumab and axitinib, both the objective response rate (ORR) as well as the complete response rate was higher among those in the normalized group (11.8%) than the normal group (3.8%) or the non-normalized group (0.9%).

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In the multivariate analysis, the authors found that normalized or non-normalized CRP was an independent predictive factor of ORR and OS for patients treated with avelumab and axitinib.

Dr. Tomita concluded that baseline normal and normalized CRP levels were associated with improved outcomes for patients receiving avelumab and axitinib.


Presented by: Yoshihiko Tomita, MD, PhD, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan


Written by: Christopher J.D. Wallis, Urologic Oncology Fellow, Vanderbilt University Medical Center, Contact: @WallisCJD on Twitter at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Virtual Annual Meeting #ASCO21, June, 4-8, 2021