Also known as: urothelial
Three trials show ultra-low-dose checkpoint inhibitors retain efficacy with reduced toxicity and dramatically lower costs. DELII and Patil et al. trials tested low-dose nivolumab in solid tumors and HNSCC; NIVIPIT tested intratumoral low-dose ipilimumab in melanoma.
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
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.
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
The FDA approved KEYTRUDA and its subcutaneous QLEX formulation for platinum-resistant ovarian cancer, marking the first PD-1 inhibitor cleared for this patient population based on Phase 3 results.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07705035 |
DBC-664 in Adult Patients With Solid Tumors |
RECRUITING | PHASE1 |
| NCT07662863 |
Sacituzumab Tirumotecan vs MMAE-ADCs in Advanced Urothelial Carcinoma (FUSCC-SPARE-UC-01) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07623369 |
A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors |
RECRUITING | PHASE1 |
| NCT07532902 |
A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer |
RECRUITING | PHASE1 |
| NCT07526792 |
SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07506057 |
Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy |
RECRUITING | PHASE2 |
| NCT07492628 |
Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma |
RECRUITING | PHASE1 |
| NCT07460245 |
Maintenance AVElumab After SECond Line Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07421700 |
Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07416123 |
A Study of GEN1106 in Participants With Solid Tumors |
RECRUITING | PHASE1 |
