Eli Lilly and Company (Lilly) has reported new positive top-line results from its RANGE trial, a Phase III placebo-controlled study.
The trial is designed to investigate the combination of CYRAMZA (ramucirumab) and docetaxel to treat patients with locally advanced, unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.
The additional findings of the trial have demonstrated a positive trend in the secondary endpoint of overall survival (OS), which did not reach statistical significance.
An improvement in objective response rate (ORR) was also reportedly observed.
The trial did not observe any new safety signals and demonstrated a consistent safety profile of CYRAMZA with the previous results of the trial.
It enrolled a total of 530 patients across the globe. Patients whose disease progressed following adjuvant and/or neoadjuvant therapy as well as after first-line therapy for metastatic disease were included in the trial.
Additionally, patients who had received prior platinum-based and immune checkpoint inhibitor regimens were enrolled in the trial.
Primary endpoints of the trial include investigator-assessed progression-free survival, while other secondary endpoints are overall survival, objective response rate, disease control rate and patient-reported outcomes.
Eli Lilly global development and medical affairs senior vice-president Levi Garraway said: “People with advanced urothelial carcinoma who experience disease progression urgently need treatment options that can control the disease – to help stop or slow the cancer from growing and spreading.
“Although this study didn’t reach statistical significance for overall survival, we are encouraged by the totality of the RANGE results and look forward to reviewing the data with internal and external experts to determine next steps.”
Urothelial cancer comprises carcinomas that arise in the urothelial or transitional cells that line the urinary collecting system such as the bladder, the most common site for this type of tumour.