Amgen today announced top-line results from a randomized Phase 3 trial evaluating Vectibix (panitumumab) as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer. The data showed the addition of Vectibix to platinum-based chemotherapy did not result in a statistically significant improvement in overall survival, the primary endpoint, compared to chemotherapy alone median 11.1 months versus 9.0 months, hazard ratio 0.87 (95% CI: 0.73, 1.05). Therefore, the study did not meet its primary endpoint. Secondary endpoints of progression-free survival median 5.8 months versus 4.6 months, hazard ratio 0.78 (95% CI: 0.66, 0.92) and objective response rate (36 percent versus 25 percent) were numerically improved but were not tested for statistical significance.
“The outcome of this study is disappointing. However, Vectibix remains an important monotherapy treatment option for patients with metastatic colorectal cancer whose disease has progressed on other therapies,” said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.