Dr Pal on the Rationale for Evaluating Atezolizumab in High-Risk Localized RCC

“The IMmotion010 study is a randomized phase 3 trial comparing atezolizumab [with] placebo in patients at high risk for recurrence with high-risk localized kidney cancer. In this particular trial, there weren’t any improvements seen in disease-free survival with atezolizumab.”

Sumanta Pal, MD, FASCO, the codirector of the Kidney Cancer Program and a professor in the Department of Medical Oncology & Therapeutics Research at the City of Hope, detailed the design of the phase 3 IMmotion010 trial (NCT03024996) that evaluated adjuvant atezolizumab (Tecentriq) compared with placebo for the treatment of patients with high-risk localized renal cell carcinoma (RCC).

Patients included in the IMmotion010 analysis all had high-risk localized RCC, Pal began. Specifically, patients included on the study had T2 grade 4 disease, T3a grade 3/4 disease, T3b/c or T4 any-grade disease, and M1 with no evidence of disease. Patients included on the study also had a clear cell histology and/or a sarcomatoid component. Patients were then stratified based on their disease stage, PD-L1 expression on tumor-infiltrating immune cells, and geographical region. Patients who were enrolled (n = 778) were randomly assigned 1:1 to be treated with either atezolizumab at 1200 mg intravenously every 3 weeks for 16 cycles or 1 year or placebo every 3 weeks for 16 cycles or 1 year.

Results from the trial revealed that there were no improvements regarding disease-free survival with atezolizumab compared with placebo, Pal continued. Nevertheless, data from the study were valuable, particularly those stemming from the specimens that were collected, he asserted. At baseline, there were specimens derived from tissue, and blood samples were also collected at baseline as well as the time of recurrence, he explained. Previous data from the study suggested that KIM-1 is a unique biomarker that could help predict outcomes with immunotherapy, specifically in the adjuvant setting, he added. Furthermore, the study included a detailed genomic analysis that evaluated the tumor at baseline and whether its potential evolution over time was associated with KIM-1, according to Pal.