Natera reports results from IMvigor011 clinical trial

Natera (NTRA) announced results from the randomized, double-blind, phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer. The findings demonstrate that Signatera can expand the adjuvant treatment window and guide the use of adjuvant atezolizumab in MIBC, resulting in improved disease-free survival and overall survival. Results will be presented during a Presidential Symposium at the European Society for Medical Oncology Congress. 761 patients were enrolled in surveillance, of whom half tested Signatera-positive and 250 were randomized to atezolizumab vs. placebo. Signatera-patients treated with atezolizumab experienced a greater than2x increase in median DFS compared to placebo. Median DFS was 9.9 months for patients treated with atezolizumab vs 4.8 months for placebo. Signatera-positive patients in the treatment arm also had a statistically significant and clinically meaningful improvement in OS. Signatera-negative patients had excellent outcomes without adjuvant immunotherapy. Patients who remained persistently Signatera-negative during surveillance without adjuvant treatment had very low recurrence risk. OS outcomes were also incredibly strong, sparing patients from unnecessary treatment and potentially associated toxicity. Data from IMvigor011 will support Natera’s premarket approval application to the FDA for Signatera as a companion diagnostic for the selection of patients with MIBC to be treated with atezolizumab after cystectomy.