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Results from the JAVELIN Renal 101 study to evaluate avelumab plus axitinib in untreated sarcomatoid renal cell carcinoma (RCC) were presented at the European Society for Medical Oncology (ESMO) conference in Barcelona over the weekend.
Sarcomatoid differentiation can occur in all subtypes of renal cell carcinoma (RCC) and is an aggressive form of RCC.
JAVELIN Renal 101 demonstrated a significant improvement in progression-free survival with avelumab plus axitinib versus sunitinib (13.8 vs 8.4 months) in patients with previously untreated clear cell metastatic RCC. The researchers conducted a post-hoc analysis of the patients in the JAVELIN Renal 101 study looking at efficacy and biomarker results from patients who had sarcomatoid RCC.
Of 886 patients with metastatic RCC enrolled in JAVELIN Renal 101, 108 (12.2%) had sarcomatoid RCC; 47 were treated with the avelumab plus axitinib combination, 61 with sunitinib.
Avelumab plus axitinib improved progression-free survival compared to sunitinib in patients with sarcomatoid RCC (7.0 months versus 4.0 months). The 12-month overall survival rate was 83.0% with the combination and 67.0% with sunitinib and objective response rate was higher (46.8% versus 21.3%). Furthermore, patients in the combination arm had 2.4 months longer median duration of response than those in the sunitinib arm.
Biomarker analysis showed that patients with sarcomatoid RCC tumours had an immunosuppressive tumour microenvironment and higher CD274 and CD8A gene expression. Also, about half of the sarcomatoid RCC had m3 tumours, which are associated with poor survival. Patients with m3 tumours who were also CD8- or CD8A-positive had longer median progression-free survival with avelumab plus axitinib than sunitinib.
In conclusion, this study found that the avelumab plus axitinib combination improved progression-free survival and objective response rate in patients with sarcomatoid RCC and provides insight into the biology of an aggressive subtype of RCC.