Top-line results of Ph III head and neck cancer trial with Amgen's Vectibix disappoint

Leading US biotechnology firm Amgen announced disappointing top-line results from a randomized Phase III trial evaluating Vectibix (panitumumab) as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer. The news saw Amgen's shares, down 13% so far this year, dip 2.2% to $54.47 in morning trading yesterday.

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% versus 25%) were numerically improved but were not tested for statistical significance, the company noted.

"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 Perlmutter, executive vice president of R&D at Amgen.