Results from the JAVELIN-Renal 101 clinical trial to assess avelumab plus axitinib in untreated patients with advanced renal cell carcinoma (RCC) with sarcomatoid characteristics were presented at the European Society for Medical Oncology (ESMO) conference in Barcelona over the weekend.
Sarcomatoid RCC is an uncommon but highly aggressive form of RCC, which tends to have worse survival outcomes with VEGF-targeted therapy compared to more common subtypes of RCC, such as clear cell RCC. JAVELIN-Renal 101 was a randomised phase III trial of first-line axitinib plus avelumab, a PD-L1 immunotherapy, versus sunitinib for metastatic RCC. A post-hoc analysis of the patients in the JAVELIN-Renal 101 study with sarcomatoid histology was carried out to look at the response to combination immunotherapy and VEGF-targeted therapy in this group of patients, and to identify predictive biomarkers.
In the study, 108 patients were identified as having sarcomatoid RCC (of a total of 886 in the study overall) and 47 of these patients were randomised to receive avelumab plus axitinib, while 61 received sunitinib. Despite lower PD-L1 positivity, the avelumab plus axitinib arm achieved a statistically significant improvement in objective response rate (46.8%) relative to sunitinib (21.3%), and 2 sarcomatoid RCC patients had a complete response to the combination. Also, treatment with the avelumab plus axitinib combination resulted in a clinically significant 3.0-month improvement in progression-free survival and statistically significant 2.4-month improvement in duration of response for sarcomatoid RCC patients.
In summary, results from the JAVELIN-Renal 101 study clearly suggest a benefit to patients with sarcomatoid RCC of immunotherapy and immunotherapy plus VEGF-targeted therapy combinations.