Results of the IMvigor011 Phase III trial show that more than 90 percent of muscle invasive bladder cancer patients with a negative circulating tumor DNA (ctDNA) test following surgery, that remained negative at follow up, did not relapse. The results of the trial, presented today at the European Association of Urology Congress in Paris, indicate that using a liquid biopsy ctDNA test could allow some patients to be spared additional treatment, with limited risk.
IMvigor011 is a global, double-blind randomized trial testing the efficacy of the immunotherapy drug atezolizumab (Tecentriq) versus placebo in patients with high-risk muscle-invasive bladder cancer (MIBC). MIBC is an advanced form of bladder characterized by its spread into the bladder wall. Treatment usually involves bladder removal and roughly half of all patients experience a return of the cancer within two-to-three years, usually in the lungs. All patients are currently offered follow-up treatments that can include chemotherapy or immunotherapy to attempt to prevent disease recurrence. But these treatments have a host of potentially serious side effects that can significantly alter the wellbeing of the patient.
“This is where the findings from the IMvigor011 trial could really make a difference, by allowing us to select patients at highest risk who will benefit the most from treatment while sparing others for whom it isn’t needed,” said Joost Boormans, professor of Urology at Erasmus University Medical Centre in Rotterdam, who is chaired the session where these results were presented. “At a time when healthcare resources are under pressure, this kind of innovation is really needed.”
Testing for the trial was provided via Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera.
Commenting on the new data, John Simmons, vice president, Biopharma at Natera noted: “IMvigor011 is an important randomized study that is designed to address a critical unmet need for the more than 35,000 patients a year diagnosed with muscle-invasive bladder cancer,” said John Simmons, vice president, BioPharma at Natera. “We believe the results of this trial will further demonstrate how Signatera can help personalize treatment decisions and improve outcomes for bladder cancer patients.”
The trial is continuing to recruit patients post-surgery to test their blood for ctDNA. Those with a positive ctDNA were randomized to receive atezolizumab or placebo. Patients with negative result (no presence of ctDNA) were provided with no further treatement, but followed for two years with scans and additional ctDNA testing. The results presented in Paris included results from 171 patients with a negative ctDNA result.
Of that total, only 17 patients (9.9%) experienced a return of cancer in two years, irrespective of the tumor stage at treatment or whether it showed elevated levels of PD-L1. Atezolizumab is an anti-PD-L1 immunotherapy from Genentech/Roche.
“These results are even better than we were hoping,” added trial leader Prof. Thomas Powles of Barts Cancer Institute, London. “The risk of relapse in this ctDNA group of patients is just one in ten. It appears this test can effectively filter patients into two groups: those who are likely to relapse and those at much lower risk.
“Focusing treatment on those at risk and sparing the very low risk group potentially life-altering treatment-related side effects is attractive. Hopefully these data will allow patients to remain treatment free with the reassurance they need, that they’re unlikely to see their cancer return.”
