ASCO GU 2019: Subgroup Analysis from JAVELIN Renal 101: Outcomes for Avelumab plus Axitinib versus Sunitinib in Advanced Renal Cell Carcinoma

San Francisco, CA ( In this podium presentation, Dr. Choueiri explained that avelumab, an anti PD-L1 monoclonal antibody and axitinib, a VEGF tyrosine kinase inhibitor, have demonstrated activity as monotherapy for advanced renal cell carcinomas (aRCC).  In a previous phase 1b trial, combination avelumab + axitinib therapy had an objective response rate of 68% and a favorable safety profile in a phase 1b study.  Furthermore, previous data also demonstrated improved progression-free survival and objective response rate (13.8 vs 8.4 mo, HR 0.69, p=0.0001; 51% vs 26% with avelumab + axitinib compared to sunitinib in patients with previously untreated advanced renal cell carcinoma (aRCC).

Dr. Choueiri discussed the JAVELIN Renal 101 trial, focusing on progression-free and overall responses, subsequent anticancer therapy, progression-free survival after next line therapy, duration of response, and safety.  In this study, patients had been randomized to receive avelumab 10mg/kg IV Q2 weeks + axitinib 5mg PO BID or sunitinib 50mg PO daily for 4 weeks.  Endpoints included progression-free survival and overall survival and subgroup analyses were performed in patients with PD-L1 positive tumors, MSKCC and IMDC risk groups.

Of the 886 patients randomized, 63% were PD-L1 positive tumors with a median follow up of approximately 12 months for both PD-L1 positive and negative cohorts.  Amongst all subgroups (MSKCC and IMDC favorable, intermediate, and poor risk, and PD-L1 status) avelumab with axitinib had superior (and statistically significant) improvement in progression-free survival and overall response rate compared to sunitinib alone.  Moreover, PFS2 was not reached in the combination cohort compared to 18.4 months in sunitinib alone (HR 0.56, 95%CI 0.421-0.735).  Patients who received avelumab + axitinib had > 4 months longer median duration of response compared to sunitinib alone. 

In conclusion, JAVELIN Renal 101 demonstrated longer progression-free survival and overall response rate for combination avelumab + axitinib compared to sunitinib for previously untreated aRCC.  Dr. Choueiri stated that this data supports avelumab + axitinib combination therapy for new first line standard of care for patients with aRCC.  Of note, this practice changing data was also published in the New England Journal of Medicine.

Presented by: Toni K. Choueiri, MD, Dana Farber Cancer Institute, Boston, Massachusetts


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