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Ramucirumab/Paclitaxel Improves Survival in Second-Line Gastric Cancer Patients

Phase III data support combination of biologic agent and chemotherapy

Positive results from a global phase III trial of ramucirumab (Cyramza, Eli Lilly) in combination with paclitaxel in patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma have been published online in The Lancet Oncology.

In the RAINBOW trial, the addition of ramucirumab to paclitaxel showed a statistically significant improvement in median overall survival (OS), meeting the study’s primary endpoint; the combination treatment also met secondary endpoints of progression-free survival (PFS) and the objective response rate (ORR).

RAINBOW was a global, randomized, double-blind study of ramucirumab and paclitaxel compared with placebo and paclitaxel in patients with advanced (i.e., locally advanced, unresectable, or metastatic) gastric cancer or GEJ adenocarcinoma that was refractory to or progressive after initial platinum- and fluoropyrimidine-containing chemotherapy.

Patients treated with ramucirumab plus paclitaxel had a median survival benefit of 9.6 months compared with 7.4 months for patients treated with placebo plus paclitaxel (stratified hazard ratio [HR], 0.807; P = 0.0169). Treatment with ramucirumab plus paclitaxel significantly reduced the risk of disease progression or death (by 37%), with a 52% increase in median PFS, compared with placebo plus paclitaxel (4.4 months vs. 2.9 months, respectively; stratified HR, 0.635; P P = 0.0001).

The following adverse events (grade 3 or higher) occurred at a higher rate and for more than 10% of patients in the ramucirumab/paclitaxel arm compared with the placebo/paclitaxel arm: neutropenia (41% vs. 19%, respectively); leukopenia (17% vs. 7%); hypertension (15% vs. 3%); and fatigue/asthenia (12% vs. 5%). The incidence of febrile neutropenia was low in both treatment arms (3% vs. 2%, respectively).

RAINBOW is the largest trial in second-line gastric cancer to date and the first phase III study to demonstrate a survival benefit with a biologic agent used in combination with chemotherapy in this setting. Data from the study were first presented at the Gastrointestinal Cancers Symposium (ASCO GI) in January 2014.

Ramucirumab has now demonstrated statistically significant improvements in both OS and PFS in two phase III gastric cancer trials. The first trial, REGARD, evaluated ramucirumab as monotherapy in patients with advanced or metastatic gastric or GEJ adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. These study results were published in 2013.

Data from the RAINBOW trial provided the basis for regulatory submission in the U.S.

Cyramza (ramucirumab) is approved for use as a single agent in the U.S. for patients with advanced gastric cancer or GEJ adenocarcinoma who have progressed after prior fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is a vascular endothelial growth factor (VEGF) receptor 2 antagonist that specifically binds and blocks activation of this receptor and prevents binding of the VEGF receptor ligands A, C, and D.

Source: Eli Lilly; September 18, 2014.

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