The FDA approves Cyramza (ramucirumab) in combination with paclitaxel for the treatment of advanced gastric cancer or GEJ adenocarcinoma.
Cyramza (ramucirumab) used in combination with paclitaxel was approved by the Food and Drug Administration for treatment of patients previously treated for advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma (where the esophagus meets the stomach). The approval was based on data from the phase 3 RAINBOW trial.
In the trial, the combination of Cyramza and paclitaxel improved overall survival by 2.3 months over paclitaxel alone, representing a 19 percent improvement. The FDA initially approved Cyramza earlier this year as a treatment for patients with unresectable gastric cancer or GEJ adenocarcinoma following fluoropyrimidine- or platinum-containing therapy, based on the phase 3 REGARD trial. In that analysis, survival was improved by 1.4 months with Cyramza as a single agent compared with placebo.
[FDA approves new drug for gastric cancer, April 22]
In the RAINBOW trial, 665 patients with GEJ and gastric adenocarcinoma received either Cyramza plus paclitaxel or placebo plus paclitaxel. Participants had been previously treated with fluoropyrimidine- or platinum-containing therapy. In the study, survival was 9.6 months with Cyramza compared with 7.4 months for paclitaxel alone. The median progression-free survival was 4.4 months compared with 2.9 months for the Cyramza and placebo arms, respectively.
“The survival difference in favor of ramucirumab plus paclitaxel was 9.7 versus 7.4 months, and this differences of 2.3 months is an astonishingly good result in such a challenging patient population,” lead study author Hansjochen Wilke, director of the department of oncology, Hematology and Center of Palliative Care at Kliniken Essen-Mitte in Essen, Germany, said when results of the RAINBOW trial were announced at the 2014 ASCO Gastrointestinal Cancers Symposium. “This difference was not only statistically significant but also clinically meaningful.” Side effects reported in the trial included neutropenia, febrile neutropenia and high blood pressure.
Results from a number of large studies exploring Cyramza have been announced in the past year. Most recently, the phase 3 RAISE trial showed the combination of Cyramza and FOLFIRI significantly improved survival and progression-free survival compared with chemotherapy alone as a second-line treatment for patients with metastatic colorectal cancer. Data from the RAISE trial is expected to be announced in 2015. The drug is also being explored in lung cancer.