The novel drug ramucirumab significantly improved survival compared with placebo among patients with metastatic refractory gastric or gastroesophageal junction cancer, according to results of the phase 3 REGARD study presented at the Gastrointestinal Cancers Symposium.
VEGF and VEGF-receptor 2 mediated signaling, as well as angiogenesis, may contribute to the development of gastric cancer. Ramucirumab (IMC-1121B, ImClone Systems) is a human monoclonal antibody that targets VEGF-receptor 2.
Charles S. Fuchs, MD, MPH, professor in the department of medicine at Harvard Medical School, and colleagues conducted a placebo-controlled, double-blind, international trial to evaluate the safety and efficacy of ramucirumab in patients with metastatic gastric or gastroesophageal junction adenocarcinoma that progressed on first-line platinum and/or fluoropyrimidine therapy.
Researchers randomly assigned 355 patients to receive ramucirumab (n=238) or placebo (n=117) every 2 weeks until disease progression, unacceptable toxicity or death. All patients also received best supportive care.
Eligible patients had disease progression within 4 months after first-line therapy or within 6 months after adjuvant therapy.
OS served as the primary endpoint. Secondary endpoints included PFS, 12-week PFS, overall response rate and safety.
Patients assigned to ramucirumab experienced significantly longer median OS (5.2 months vs. 3.8 months; HR=0.776; 95% CI, 0.603-0.998) and PFS (2.1 months vs. 1.3 months; HR=0.483; 95% CI, 0.376-0.620) than patients assigned to placebo.
Patients in the ramucirumab group also had a higher rate of 12-week PFS rate (40% vs. 16%), a higher overall response rate (3.4% vs. 2.6%) and higher disease control rate (49% vs. 23%) compared with those in the placebo arm (P<.0001).
The most frequent grade 3 or higher adverse events reported by patients assigned to ramucirumab were hypertension, anemia, abdominal pain, ascites, fatigue, decreased appetite and hyponatremia.
For more information:
Fuchs CS. Abstract #LBA5. Presented at: Gastrointestinal Cancers Symposium; Jan. 24-26, 2013; San Francisco.
Disclosure: The researchers report serving as consultants/advisers for, as well as receiving research funding and honoraria from, Amgen, Bayer, Bristol-Myers Squibb, Genentech, Infinity Pharmaceuticals, ImClone Systems, Lilly, Merck KGaA, Novartis, Pfizer, Roche and other pharmaceutical companies.