BioCentury
ARTICLE | Clinical News

Lilly submitting ramucirumab as gastric cancer combo

September 27, 2013 2:15 AM UTC

Eli Lilly and Co. (NYSE:LLY) said it will submit regulatory applications for ramucirumab in combination with paclitaxel to treat gastric cancer but will not submit an application for the VEGFR-2 antagonist to treat recurrent or metastatic HER-2 negative breast cancer. Lilly announced Phase III data in both indications Tuesday. The ramucirumab and paclitaxel combination met the primary endpoint of improving overall survival (OS) in the Phase III RAINBOW trial in 665 patients with advanced gastric cancer refractory to, or progressive after, first-line chemotherapy containing platinum and fluoropyrimidine.

Ramucirumab missed the primary endpoint of improving progression-free survival (PFS) in the Phase III ROSE/TRIO-012 trial in 1,144 patients with unresectable, locally recurrent or metastatic HER2-negative breast cancer. ...