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Ramucirumab/Paclitaxel Combo Approved for Gastric Cancer

Ramucirumab now indicated as both single agent and chemotherapy support

The FDA has approved ramucirumab (Cyramza, Eli Lilly) in combination with paclitaxel (a type of chemotherapy) as a treatment for patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Ramucirumab now has two FDA approvals for these patients. The new decision follows the April approval of ramucirumab as a single agent –– the first approval of a treatment in the U.S. for patients in this setting.

Stomach cancer is the fifth most common cancer in the world and is the third-leading cause of cancer death. In the U.S., approximately 22,000 people will be diagnosed with stomach cancer in 2014. Cyramza (ramucirumab injection 10 mg/mL solution) is the only FDA-approved second-line treatment option for patients with advanced or metastatic gastric or GEJ adenocarcinoma whose disease has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

The new FDA approval of ramucirumab was based on results from the phase III RAINBOW trial, which compared ramucirumab plus paclitaxel with placebo plus paclitaxel. The study’s endpoints included the major efficacy outcome measure of overall survival (OS) and the supportive efficacy outcome measures of progression-free survival (PFS) and the objective response rate.

Initiated in 2010, the randomized, double-blinded, placebo-controlled RAINBOW study involved a total of 665 patients in 27 countries in North America, South America, Europe, Australia, and Asia. It was the first phase III study to demonstrate a survival benefit with a biologic used in combination with chemotherapy in patients with gastric or GEJ adenocarcinoma.

Ramucirumab plus paclitaxel significantly extended median OS compared with placebo plus paclitaxel (9.6 months vs. 7.4 months, respectively; hazard ratio [HR], 0.81; P = 0.017). Further, ramucirumab plus paclitaxel significantly delayed disease progression (PFS of 4.4 months for ramucirumab plus paclitaxel vs. 2.9 months for placebo plus paclitaxel; HR, 0.64; P < 0.001).

Significantly more patients responded to ramucirumab combined with paclitaxel than to placebo plus paclitaxel (28% vs. 16%, respectively; P < 0.001). The percentage of deaths at the time of the analysis was 78% (256 patients) and 78% (260 patients) in the ramucirumab -plus-paclitaxel and placebo-plus-paclitaxel treatment arms, respectively. The number of PFS events was 279 (85%) and 296 (88%) for the ramucirumab -plus-paclitaxel and placebo-plus-paclitaxel treatment arms, respectively.

The most common serious adverse events with ramucirumab plus paclitaxel in the RAINBOW trial included neutropenia (3.7%) and febrile neutropenia (2.4%); 19% of patients treated with ramucirumab plus paclitaxel received granulocyte colony-stimulating factors as a treatment for low white blood cell counts.

The labeling for ramucirumab contains a boxed warning regarding an increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. Ramucirumab should be permanently discontinued in patients who experience severe bleeding.

Ramucirumab is an antiangiogenic therapy. It is a vascular endothelial growth factor receptor-2 (VEGFR-2) antagonist that specifically binds to and blocks the activation of VEGFR-2 by interfering with the binding of the receptor ligands VEGF-A, -C, and -D.

Source: Eli Lilly; November 5, 2014.

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