Ramucirumab/Paclitaxel Combo Approved for Gastric Cancer

Zosia Chustecka

November 06, 2014

The new antiangiogenesis agent ramucirumab (Cyramza, Lilly) has been granted an indication extension by the US Food and Drug Administration (FDA).

Ramucirumab was approved earlier this year for use as a single agent; now it is also approved for use in combination with paclitaxel (Taxol, Bristol-Myers Squibb). Both are used to treat advanced or metastatic gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma in patients whose cancer has progressed during or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Gastric cancer is the fifth most common cancer in the world and is the third-leading cause of cancer death, the manufacturer noted in an announcement. In the United States, gastric cancer will be diagnosed in approximately 22,000 people in 2014.

Ramucirumab is the only FDA-approved second-line treatment option for patients with advanced or metastatic gastric or GEJ adenocarcinoma whose disease has progressed during or after prior fluoropyrimidine- or platinum-containing chemotherapy, the company notes. It has orphan drug designation for this indication.

The FDA approval for use of the drug in combination with paclitaxel is based on the results from the phase 3 RAINBOW trial, which compared the combination with paclitaxel alone. The results showed a significant improvement in overall survival (9.6 vs 7.4 months; hazard ratio [HR], 0.87; P = .0169), as reported earlier this year at the 2014 Gastrointestinal Cancers Symposium. The results were highlighted at a press briefing, at which Smitha S. Krishnamurthi, MD, associate professor of medicine at Case Western Reserve University in Cleveland, Ohio, said, "This is the only study to date to demonstrate a 2-month improvement in survival in this setting, and with a relatively high 28% response rate for the combination therapy." 

The ramucirumab and paclitaxel combination was associated with better median progression-free survival than was monotherapy (4.4 vs 2.8 months; HR, 0.635; P < .0001). In addition, patients treated with the combination also had a significantly better median time to progression (5.5 vs 3.0 months; P < .0001) and a better objective response rate (28% vs 16%; P = .0001).

However, adverse events increased with the combination. Most adverse events of grade 3 or greater occurred at least twice as often with the combination as with paclitaxel alone, including neutropenia  (40.7% vs 18.8%), leukopenia (17.4% vs 6.7%), hypertension (14.1% vs 2.4%), fatigue (7.0% vs 4.0%), abdominal pain (5.5% vs 3.3%), and asthenia (5.5% vs 3.3%). Febrile neutropenia was reported more often with the combination than with monotherapy (3.1% and 2.4%). In contrast, anemia  was slightly less common with the combination (9.2% vs 10.3%).

Ramucirumab carries a boxed warning about the increased risk for hemorrhage, including severe and sometimes fatal hemorrhagic events.

The RAINBOW trial was funded by the manufacturer, Lilly.

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