Ramucirumab: Phase III data

The double-blind, international Phase III REVEL trial in >1,200 NSCLC patients with disease progression after platinum-based chemotherapy showed that 10 mg/kg IV ramucirumab plus docetaxel on day 1 of each 21-day cycle met the primary endpoint of improving OS vs. placebo plus docetaxel. Ramucirumab plus docetaxel also met the secondary endpoint of improving PFS vs. placebo plus docetaxel. The most common grade >=3 adverse events reported at a higher rate in the ramucirumab arm were neutropenia/leukopenia, febrile neutropenia, fatigue/asthenia and hypertension. The trial included squamous and non-squamous NSCLC patients. Lilly said it plans to begin submitting regulatory applications for ramucirumab in NSCLC this year, including an application to FDA next half.

Last October, FDA accepted and granted Priority Review to a BLA for ramucirumab as monotherapy for second-line gastric cancer. The pharma said it expects a decision from the agency in 2Q14, but did not disclose a specific PDUFA date (see BioCentury, Oct. 28, 2013). Ramucirumab is also under review in Europe for the indication. This year, Lilly plans to submit regulatory applications for ramucirumab to treat second-line gastric cancer in combination with paclitaxel. ...