FDA Approves Atezolizumab in MIBC Post-Cystectomy with ctDNA MRD

The FDA has approved atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for the adjuvant treatment of muscle invasive bladder cancer (MIBC) after cystectomy in those with circulating tumor DNA (ctDNA) molecular residual disease (MRD), according to a press release from the FDA.¹

The Signatera CDx has also been approved as a companion diagnostic to identify patients with MIBC after cystectomy with ctDNA MRD who are eligible for atezolizumab, as well as atezolizumab and hyaluronidase-tqjs.

The FDA’s decision was supported by findings from the multi-center, randomized phase 3 IMvigor011 trial (NCT04660344), which evaluated adjuvant atezolizumab vs placebo in MIBC with ctDNA positivity and at a high risk of recurrence following cystectomy.²

Patients who received atezolizumab achieved a median disease-free survival (DFS) of 9.9 months (95% CI, 7.2-12.7) compared with 4.8 months (95% CI, 4.1-8.3) in those who received placebo (HR, 0.64; 95% CI, 0.47-0.87; P = .0047). Further, the median overall survival (OS) was 32.8 months (95% CI, 27.7-not estimable [NE]) vs 21.1 months (95% CI, 14.7-NE), respectively (HR, 0.59; 95% CI, 0.39-0.90; P = .0131).

The trial enrolled 250 patients with MIBC who had radical cystectomy with lymph node dissection. All patients also had MRD positivity detected by serial ctDNA MRD evaluation of blood during the subsequent 12 months, starting at least 6 weeks after cystectomy. Randomization was done at a 2:1 ratio, with patients either receiving atezolizuamb at 1680 mg or placebo intravenously every 4 weeks.

The primary end point of the trail was DFS, and OS was an additional efficacy outcome.

Recommended Dosage

Atezolizumab has been assigned a recommended dose of 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for up to 1 year, all administered intravenously. The recommended dose of atezolizumab and hyaluronidase-tqjs is 1875 mg of atezolizumab and 30,000 units of hyaluronidase subcutaneously every 3 weeks for up to a year.

The agency also noted that patients who receive a negative Signatera CDx test reading should continue with serial testing until a positive test result or completion of the recommended 12-month testing window.

Regarding safety, the prescribing information for both approved treatments includes warnings and precautions for immune-mediated adverse events, infusion-related reactions, complications of hematopoietic stem cell transplantation, and embryo-fetal toxicity.

References

1. FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease. News release. FDA. May 15, 2026. Accessed May 15, 2026. https://tinyurl.com/msrrrt9u
2. A study of atezolizumab versus placebo as adjuvant therapy in participants with high-risk muscle-invasive bladder cancer (MIBC) who are ctDNA positive following cystectomy (IMvigor011). ClinicalTrials.gov. Updated March 27, 2026. Accessed May 15, 2026. https://tinyurl.com/mse53sw2