FDA approves Tecentriq for adjuvant muscle-invasive bladder cancer with ctDNA-guided treatment
The FDA approved Tecentriq and Tecentriq Hybreza for adjuvant muscle-invasive bladder cancer with ctDNA molecular residual disease after cystectomy. The Phase III IMvigor011 study showed a 36% reduction in recurrence or death and a 41% reduction in death.
The U.S. Food and Drug Administration has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer who have circulating tumor DNA molecular residual disease after cystectomy, as identified by Natera’s Signatera CDx personalized MRD assay. The approval marks the eleventh indication for Tecentriq in the U.S. and represents the first approval of a ctDNA-guided therapy.
The FDA decision was based on positive results from the Phase III IMvigor011 study, which showed that Tecentriq reduced the risk of disease recurrence or death by 36% and the risk of death by 41% in patients with detectable ctDNA molecular residual disease identified via serial testing within one year of cystectomy. The safety profile was generally consistent with previous studies of Tecentriq.
IMvigor011 is the first prospective Phase III study to demonstrate that a ctDNA-guided approach to adjuvant therapy can significantly improve survival in muscle-invasive bladder cancer. The Signatera CDx test received simultaneous authorization by the FDA for use as a companion diagnostic to Tecentriq.
The surveillance phase of IMvigor011 included 761 people who underwent serial ctDNA testing for up to a year after surgery. Of these, 250 people who tested positive for ctDNA joined the treatment phase, where they received either Tecentriq or placebo. The primary endpoint is investigator-assessed disease-free survival. Secondary endpoints include overall survival and tolerability, amongst others.
Each year, over 150,000 people worldwide are diagnosed with muscle-invasive bladder cancer and undergo bladder removal surgery to treat this aggressive disease. Even after surgery, nearly half of these patients see their cancer return. Historically, doctors have relied on tumor staging to determine who needs treatment after surgery, while the IMvigor011 study utilized the Natera Signatera personalized ctDNA assay to identify molecular evidence of cancer in the blood before it becomes visible with standard imaging.