Clinical trial results support ctDNA-guided therapy for bladder cancer, with the phase III IMvigor011 trial showing improved survival outcomes. Standardisation efforts are underway through position papers from professional societies and consensus guidelines. Nanotechnology advances and AI integration are poised to improve ctDNA detection sensitivity for liquid biopsy applications.
Recent studies and expert discussions highlight using ctDNA testing to guide surgery decisions for older ER-positive breast cancer patients and integrating FAST-Forward and PRIME II trial data to personalize radiation therapy and sequence with ADCs like T-DXd.
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.
FDA approval of daratumumab for high-risk smoldering multiple myeloma marks a shift from observation to early intervention. In a Phase II trial in earlier-stage disease, the overall response rate was 54% and the primary endpoint was not met.
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
Two studies show liquid biopsy can predict immunotherapy response in HER2-negative breast cancer and identify which patients with relapsed germ cell tumors may benefit from high-dose chemotherapy, advancing precision oncology.
Studies in gastroesophageal and locally advanced rectal cancers linked dynamic ctDNA monitoring to treatment response and prognosis. MRD clearance, more than 90% ctDNA declines, and early ctDNA clearance were associated with better outcomes.
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.
A new four-marker blood test detects pancreatic cancer with 91.9% accuracy across all stages and 87.5% accuracy for early-stage disease. The test combines two newly identified proteins with existing biomarkers and can differentiate cancer from non-cancerous conditions. While promising for pancreatic cancer, most cancers still cannot be reliably diagnosed with blood tests alone.
