FDA Approves Cyramza™ in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

The U.S. Food and Drug Administration(FDA) has approved Cyramza™ (ramucirumab) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma. Cyramza was approved in April 2014 as a single agent for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma refractory to or progressive following first-line therapy with platinum or fluoropyrimidine chemotherapy.

The approval of Cyramza in combination with paclitaxel was based on the demonstration of improved overall survival in a multicenter, double-blind, placebo-controlled study (I4T-IE-JVBE) that enrolled 665 patients with previously treated advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Cyramza significantly improved both progression-free and overall survival, when added to paclitaxel in second-line therapy for metastatic gastric cancer, according to the results of a study presented at the 2014 Gastrointestinal Cancers Symposium.

Gastric cancer refers to cancer of the stomach. Though gastric cancer has a relatively low incidence in the United States, it is the second leading cause of cancer death worldwide. The incidence of gastric cancer is quite high in Asian countries such as Korea, China, Taiwan, and Japan. Treatment of gastric cancer typically involves surgical removal of the cancer followed by the use of chemotherapy with or without radiation therapy.

Cyramza is a type of targeted agent known as a monoclonal antibody. It blocks VEGFR-2 and starves tumors of nutrients needed to grow.

The RAINBOW trial was a randomized, double-blind, placebo-controlled, phase III study that included 665 patients with metastatic gastroesophageal junction or gastric adenocarcinoma who had disease progression while on or within 4 months after a standard first-line chemotherapy regimen. Patients in the study were randomly assigned to receive Cyramza plus paclitaxel or paclitaxel alone until disease progression or intolerable toxicity. The primary endpoint was overall survival.

The results showed an advantage with the addition of Cyramza. Median overall survival was 9.6 months for patients who received Cyramza/paclitaxel compared with 7.4 months for those who received paclitaxel alone. This reflected a 19 percent reduction in the risk of death with Cyramza/paclitaxel. Median progression-free survival was 4.4 months with Cyramza/paclitaxel, compared to 2.9 months with paclitaxel alone. Median time to progression was 5.5 months and 3.0 months, respectively.

The objective response rate with Cyramza/paclitaxel was 28 percent compared to 16 percent with paclitaxel alone and the disease control rate was 80 percent and 64 percent, respectively.

Grade 3 or higher adverse events were more common in the Cyramza/paclitaxel group (82% vs 63%) and these included neutropenia, leukopenia, hypertension, and fatigue. Grade 3 and 4 neutropenia occurred more frequently in the Cyramza/paclitaxel, but the incidence of febrile neutropenia was comparable between the two groups.

The researchers concluded that Cyramza significantly improved both progression-free and overall survival, when added to paclitaxel in second-line therapy for metastatic gastric cancer. They note that “A statistically significant and clinically meaningful overall survival benefit of more than 2 months was observed for Cyramza™ plus paclitaxel versus paclitaxel alone.”

The recommended dose and schedule for Cyramza in combination with paclitaxel for advanced gastric or gastroesophageal junction adenocarcinoma is Cyramza at 8 mg/kg intravenously administered every 2 weeks and paclitaxel at 80 mg/m2 intravenously once a week for 3 weeks of every 28-day cycle. Treatment should continue until disease progression or unacceptable toxicity.

Reference:

Wilke H, Van Cutsem E, Oh SC, et al: RAINBOW: A global, phase III, randomized, double-blind study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in the treatment of metastatic gastroesophageal junction (GEJ) and gastric adenocarcinoma following disease progression on first-line platinum- and fluoropyrimidine-containing combination therapy rainbow IMCL CP12-0922 (I4T-IE-JVBE). Presented at the 2014 Gastrointestinal Cancers Symposium. Journal of Clinical Oncology. 2014; 32 (supplement 3; abstract LBA7).

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