Lilly announced that the Phase 2 study of Cyramza (ramucirumab) in combination with docetaxel met its primary endpoint, demonstrating a statistically significant increase in progression-free survival (PFS) for patients with locally advanced or metastatic urothelial carcinoma who failed prior platinum-based therapy.
The Phase 2 study was a three-arm trial evaluating 140 patients with advanced carcinoma of the urothelial tract (bladder, urethra, ureter, or renal pelvis) who, after a first-line platinum-based chemotherapy regimen, had relapsed up to one year following the initial treatment. Patients were randomized to receive either ramucirumab and docetaxel combination (n=46), docetaxel alone (n=45), or icrucumab and docetaxel combination (n=49). Treatment continued until disease progression or until treatment interruption due to drug toxicity. The primary endpoint was median PFS.
Patients treated in the ramucirumab-docetaxel arm showed a median PFS of 5.4 months (HR 0.389; 95% CI: 0.389 0.235–0.643; P<0.001) as compared to 2.8 months with docetaxel alone, and 1.6 months with icrucumab and docetaxel. Objective response rate (ORR) results also favored the ramucirumab combination arm with a significantly higher confirmed ORR (24%) compared to those on the docetaxel arm (9%) and the icrucumab combination arm (12%). Final results of the trial were presented at the European Cancer Congress 2015 in Vienna.
Based on these findings, Lilly recently initiated a Phase 3 trial (RANGE) comparing ramucirumab and docetaxel vs. placebo and docetaxel in patients with locally advanced or unresectable metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.
Cyramza is a vascular endothelial growth factor (VEGF) receptor 2 antagonist. It is FDA-approved as monotherapy or in combination with paclitaxel for the treatment of advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy; in combination with docetaxel for the treatment of metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy; and in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) for the treatment of metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
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