Trial Evaluating Nivolumab Plus Ipilimumab for Localized RCC Misses Endpoint
The CheckMate -914 trial included patients with localized RCC who underwent radical or partial nephrectomy and who were at high risk of relapse.
The CheckMate -914 trial included patients with localized RCC who underwent radical or partial nephrectomy and who were at high risk of relapse.
The investigational product targets CD70, which is highly expressed in renal cell carcinoma with limited normal tissue expression.
The sBLA submissions are supported by data from the phase 3 KEYNOTE-564 trial and the phase 2 KEYNOTE-158 trial.
The approval was based on data from the phase 3 CheckMate-274 trial which evaluated nivolumab as an adjuvant treatment in 699 adults who have undergone radical surgery for invasive urothelial carcinoma at high risk of recurrence.
Vicineum is an investigational locally administered recombinant fusion protein that targets EpCAM antigens on the surface of tumor cells to deliver Pseudomonas Exotoxin A.
The approval was based on data from an open-label phase 2 study which evaluated the efficacy and safety of Welireg in patients with von Hippel-Lindau-associated renal cell carcinoma and other VHL-associated tumors.
Full approval was granted based on overall survival data from a confirmatory trial.
Devimistat targets the mitochondrial tricarboxylic acid cycle selectively in cancer cells.