These is a statement from Genentech, which is a member of the Roche Group: ‘Upon receiving approvals from the U.S.
In addition, Food and Drug Administration (FDA), Tecentriq and Tecentriq Hybreza will be indicated for adjuvant treatment in adults with MIBC who have undergone cystectomy and are ctDNA MRD positive.
“Combining our cancer immunotherapy Tecentriq with state-of-the-art MRD testing allows more precise identification of patients who are candidates for intervention and those who might safely avoid unnecessary treatment,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We look forward to delivering this first of its kind ctDNA-guided regulatory approval to bladder cancer physicians and patients in the U.S.”
Was approved based on results from the Phase III IMvigor011 clinical trial. It was demonstrated that Tecentriq reducesthe risk of cancer recurrence or death by 36% and the risk of death by 41% in patients with circulating tumor DNA (ctDNA) MRD, measured by serial blood testing for ctDNA 12 months after cystectomy.
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Finally, this was the first prospective Phase III trial ever to show that a ctDNA driven approach of the use of adjuvant therapy could A lot improve survival in patients with muscle-invasive bladder cancer.
“For the patients and families, the ‘watch and wait’ period after a cystectomy is often defined by uncertainty. This ctDNA-guided approach can enable doctors to use serial ctDNA MRD testing to identify who is at a higher risk of recurrence and move quickly toward immunotherapy for those who may benefit from it, while allowing others to safely avoid additional treatment and its associated side effects,” said Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network.
Muscle-invasive bladder cancer is a highly fatal disease accounting for over 150,000 deaths per year worldwide from bladder extirpation. In fact, up to 50% of patients will die from disease following extirpative therapy, emphasizing the importance of improving treatment options following cystectomy. Until recently, cancer stage has been the main predictor in selecting who needs further treatment after surgery.
The IMvigor011 trial utilised the ability of the Signatera TM assay to molecularly detect residual cancer in the blood, before radiological evidence of recurrence in imaging scans. The use of a ctDNA-guided strategy to select patients most at risk for recurrence allows opportunities for targeted use of immunotherapy.
For those patients most likely to benefit from therapy, treatment can be provided rather than exposing other patients to the toxicities of treatment they may not need.
