Natera says IMvigor011 bladder cancer trial achieves positive results

Natera (NTRA) announced positive topline results from the randomized, phase III IMvigor011 clinical trial in muscle-invasive bladder cancer. The trial is sponsored by Genentech, a member of the Roche Group (RHHBY). IMvigor011 utilizes the Signatera ctDNA test in patients with MIBC to detect molecular residual disease in the bloodstream after surgery and predict who will benefit from adjuvant treatment with the cancer immunotherapy atezolizumab. Approximately 760 patients were enrolled in the surveillance phase of the trial and underwent serial Signatera testing for up to 12 months post surgery. Patients were randomized to treatment with atezolizumab or placebo if they tested Signatera-positive and remained free of cancer recurrence on imaging with treatment administered every 4 weeks for 12 cycles or up to one year. Patients who consistently tested Signatera-negative were not randomized to treatment but continued to be followed up with radiographic imaging and ctDNA MRD testing. Topline results from IMvigor011 demonstrated a statistically significant and clinically meaningful improvement in disease-free survival and overall survival for Signatera-positive patients treated with atezolizumab. Natera expects trial data to be presented at an upcoming medical conference. “The results of IMvigor011 are very significant, opening the door for a new treatment paradigm for bladder cancer patients who are positive for recurrence on a molecular level but have no evidence of disease on imaging,” said Professor Thomas Powles, MBBS, MRCP, M.D., lead principal investigator of the study; Barts Cancer Institute QMUL. “We look forward to presenting the positive results later this year.”