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This study reports that C-reactive protein levels at baseline and after treatment may contribute to predicting the therapeutic efficacy of avelumab plus axitinib in patients suffering from advanced renal cell carcinoma.

C-reactive protein (CRP) is an important predictive and prognostic marker in the case of advanced renal cell carcinoma (aRCC). In this clinical trial, the patients were divided into normalized, non-normalized, and normal groups based on baseline CRP levels within sunitinib and avelumab plus axitinib treatment arms. The study concluded that baseline and treatment-related levels of CRP in aRCC patients can help predict the efficacy of avelumab plus axitinib. The study findings are published in the journal ESMO Open.

Efficacy of Sunitinib and Avelumab Plus Axitinib 

The follow-up duration of the second interim analysis (IA2) and third interim analysis (IA3) was 13 and 28 months, respectively. The objective response rate (ORR) of both treatment arms was found to be favorable in normalized and normal CRP groups compared to the non-normalized CRP group. The ORRs were 56.0%, 66.7%, and 45.4% in normal, normalized, and non-normalized CRP groups, respectively, in the avelumab plus axitinib treatment arm. On the contrary, the ORRs were 30.6%, 41.7%, and 19.5% in normal, normalized, and non-normalized CRP groups, respectively, in the sunitinib treatment. Moreover, compared to the sunitinib treatment arm, the progression-free survival (PFS) was longer in duration in the normalized CRP group.

 Survival of Patients in Sunitinib and Avelumab Plus Axitinib Treatment Arms

There was a higher risk of death in normalized and non-normalized CRP groups compared to that in the normal CRP group in the avelumab plus axitinib treatment arm. A similar trend was observed in the respective CRP groups in the sunitinib treatment arm. According to the study results, there were better efficacy outcomes with avelumab plus axitinib treatment compared to sunitinib in CRP groups.

Treatment Efficacy and Baseline Characteristics of Patients

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According to the analysis of the OS of aRCC patients, it was found that there was a significantly higher risk of death in patients with 1, 2, 3, and 4–6 International Metastatic RCC Database Consortium (IMDC) risk factors and in patients with 2 or 3 target tumor sites.

The current study demonstrated that avelumab plus axitinib treatment has greater efficacy outcomes in aRCC patients compared to sunitinib treatment in all the CRP groups.


Tomita, Y., Larkin, J., Venugopal, B., Haanen, J., Kanayama, H., Eto, M., Grimm, M. O., Fujii, Y., Umeyama, Y., Huang, B., Mariani, M., di Pietro, A., & Choueiri, T. K. (2022). Association of C-reactive protein with efficacy of avelumab plus axitinib in advanced renal cell carcinoma: long-term follow-up results from JAVELIN Renal 101. ESMO Open, 7(5), 100564. https://doi.org/10.1016/j.esmoop.2022.100564