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.
FDA approves Genentech's Tecentriq as first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, and Venclexta plus acalabrutinib as first all-oral fixed-duration regimen for CLL.
Studies in muscle-invasive bladder cancer found ctDNA predicted metastatic risk after bladder-sparing treatment, while urine tumor DNA was more sensitive for residual bladder disease. Data from RETAIN-2 and a PNAS study support molecular testing to help select patients for bladder preservation.
Durvalumab has been approved for rollout on the NHS for muscle-invasive bladder cancer. In a trial of more than 1,000 patients, it cut the risk of progression by 32% versus standard care.
Pembrolizumab-based regimens demonstrated significant survival improvements in two separate trials: KEYNOTE-B15 for muscle-invasive bladder cancer and KEYNOTE-B96 for platinum-resistant ovarian cancer, with FDA approval granted for the ovarian cancer indication.
Merck announced multiple data presentations at the 2026 ASCO GU Cancers Symposium, including results from trials evaluating pembrolizumab combinations in muscle-invasive bladder cancer and renal cell carcinoma.
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
Phase III KEYNOTE-B15 trial demonstrates enfortumab vedotin plus pembrolizumab significantly improves event-free survival and pathologic complete response rates compared with cisplatin-based chemotherapy in muscle-invasive bladder cancer.
The 2026 ASCO GU Symposium featured significant trial results in renal cell carcinoma, urothelial carcinoma, and prostate cancer, including data from LITESPARK-022, KEYNOTE-B15, SunRISE-2, and PEACE-3 studies.
Ultrasensitive testing of tumor DNA in blood and urine may identify muscle-invasive bladder cancer patients who can safely forgo radical cystectomy, with 69% achieving 3-year bladder-intact survival after systemic therapy.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07578233 |
Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Muscle Invasive Bladder Cancer |
COMPLETED | |
| NCT07318051 |
Sample Collection for Ongoing Research and Product Evaluation Study |
RECRUITING | |
| NCT07202819 |
Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy |
RECRUITING | NA |
| NCT07008833 |
Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer |
NOT_YET_RECRUITING | NA |
| NCT06916494 |
Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer |
RECRUITING | PHASE1 |
| NCT06807008 |
A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI |
COMPLETED | |
| NCT06623162 |
Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients |
NOT_YET_RECRUITING | PHASE2 |
| NCT05979740 |
RC48 Combined With Toripalimab and Radiotherapy for Bladder Sparing Treatment in MIBC |
UNKNOWN | PHASE2 |
| NCT05860543 |
Clinical Performance Evaluation of the C2i Test |
WITHDRAWN | |
| NCT05236218 |
To Better Understand the Most Important Factors for Patients When They Decide on the Type of Treatment They Receive for Muscle Invasive Bladder Cancer (MIBC). |
UNKNOWN |
