As seen in previous analyses of these data, the Vectibix group showed a statistically significant improvement in progression-free survival versus those who received BSC alone yielding a 46 percent decrease in the relative progression rate. The mean progression-free survival was 96 versus 60 days.
A blinded central review showed that 10 percent of patients in the Vectibix group had an objective response, while no patients in the BSC group demonstrated an objective response. Median time to response was 7.9 weeks and median duration of response was 17 weeks.
In the BSC group 174 (75 percent) patients received Vectibix under the crossover protocol. In those patients that crossed over, the objective response rate was 10 percent. The median time to crossover was 7.0 (6.6, 7.3) weeks. The median follow-up after crossover was 27 (4-69) weeks.
In the primary analysis of overall survival, there was no significant difference between the groups. The median follow-up time was 72 weeks for all patients.
A broadly-based clinical development program designed to examine the utility of Vectibix in the first- and second-line treatment of metastatic colorectal cancer, as well as head and neck cancer is ongoing.
Important Product Safety Information
As described below, the Vectibix Prescribing Information includes warning language:
Dermatologic toxicities, related to Vectibix blockade of EGF
binding and subsequent inhibition of EGFr-mediated signaling
pathways, were reported in 89 percent of patients and were severe
(NCI-CTC grade 3 and higher) in 12 percent of patients receiving
Vectibix monotherapy. The clinical manifestations included, but
were not limited to, dermatitis acneiform, pruritus, erythema,
rash, skin exfoliation, paronychia, dry skin, and skin fissures.