Clinicaltrials.gov identifier:
Sponsor:
Eli Lilly and Company
Enrollment:
530
Study Design:
This is a Phase III, randomized double-blind, clinical trial comparing docetaxel to docetaxel and RAM in patients with progressive advanced or metastatic UC after platinum-based chemotherapy with the primary endpoint being PFS. Secondary endpoints included OS and objective response rate (ORR). Of note, patients were allowed to have received previous immune checkpoint inhibitor treatment.
Rationale:
Again, given the limited options for platinum-refractory advanced or metastatic UC, this phase III trial evaluates the addition of ramucirumab (RAM) to docetaxel in these patients. Ramucirumab is a monoclonal antibody directed against VEGFR-2. In a previous phase II trial, the combination significantly improved median PFS over docetaxel alone.
Comments:
This trial demonstrated the first statistically significant improvement in PFS in patients that have received previous platinum-based chemotherapy and possibly a previous immune-checkpoint inhibitor.
Results:
Median PFS was slightly prolonged in the combination group compared to docetaxel plus placebo (4.1 vs. 2.8 months; HR 0.76, p=0.0118). The data were immature for OS determination but ORR was higher in the combination arm (24.5% vs. 14.0%). Finally, grade 3 adverse events were similar between the arms.
