“The RAISE study met its primary endpoint,” Dr. Tabernero said in a press briefing held before the symposium. “The combination of ramucirumab and FOLFIRI was well tolerated, and overall, the adverse events that patients presented with were manageable.”
“The RAISE study clearly demonstrates that sustained inhibition of the angiogenesis pathway from first-line to second-line metastatic colorectal cancer improves survival in a clinically representative metastatic colorectal cancer population,” he added. “Therefore, ramucirumab is an effective new treatment option for second-line treatment, including patients with poor prognosis.”
“This is the first randomized study indicating activity for ramucirumab in colorectal cancer,” noted press briefing moderator Dr. Smitha S. Krishnamurthi of Case Western Reserve University, Cleveland. “It’s always exciting to have a new active drug for our patients.”
Ramucirumab now adds to the options of continuing bevacizumab and switching to ziv-aflibercept (Zaltrap) as a component of second-line therapy when patients have a failure of bevacizumab-containing first-line therapy, she said. Oncologists in the United States typically continue bevacizumab, likely because patients are familiar with this agent and presumably tolerating it, but emerging data may establish differing safety and/or efficacy profiles that could shift practice patterns.
“All of these approaches have had a similar increase in survival. It will be interesting to see the effect of ramucirumab in other randomized studies and settings for colorectal cancer,” she added.
Dr. Krishnamurthi acknowledged that the absolute gain in survival with ramucirumab in RAISE was modest. “We’d like the results to be even stronger, but what we find with our patients with colorectal cancer is that as they get exposed to all of our active drugs; it does translate into them living longer,” she said. “So I understand 1.5 months is not a long time, but we want to offer everything that we can to our patients, especially because these agents tend to be well tolerated and can be easily combined with chemotherapy.”