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news.ImClone Systems and Bristol-Myers Squibb Company have announced positive five-year overall survival data from the pivotal Phase III study examining Erbitux combined with radiation in patients with locally or regionally advanced squamous cell carcinoma of the head and neck.
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Analysis of these five-year data demonstrates that the addition of Erbitux to radiation therapy resulted in a significant increase in median overall survival for patients with squamous cell carcinoma of the head and neck, when compared to radiation therapy alone [49 versus 29.3 months, respectively; p=0.018, Hazard Ratio (HR)=0.725, 95% CI (0.556-0.946)].
The overall survival rate at five years was 45% versus 36%, respectively (p=0.018); survival rate at three years was 55% versus 45% (p=0.05), respectively. These data are consistent with results in the current head and neck labeling for Erbitux, which include the median overall survival rate [49 versus 29.3 months, respectively; p=0.03, HR=0.74, 95% CI (0.57-0.97)].
The international, randomized study (IMCL-9815), conducted by ImClone and its partner Merck KGaA, Darmstadt, Germany, enrolled 424 previously untreated patients with locally or regionally advanced squamous cell carcinoma of the oropharynx (area of the throat at the back of the mouth), larynx (voice box) or hypopharynx (cavity at the back of the mouth that opens into the esophagus) that has spread through the head and neck region.
Patients were randomly assigned to receive Erbitux plus radiation (n=211) or radiation alone (n=213) for six to seven weeks. Erbitux was dosed weekly, starting one week before radiation and for the duration of radiation therapy. The median number of Erbitux doses administered in the clinical study was eight (1-11 infusions). As part of this pre-specified analysis, patients were evaluated during semi-annual follow-up exams during years three through five.
Maurizio Voi, executive director, oncology global medical affairs, Bristol-Myers Squibb, said: “These updated five-year overall survival data further support our belief in Erbitux as the first biologic approved to treat head and neck cancer in more than 30 years, and are part of a comprehensive clinical development program designed to fully understand the potential uses of Erbitux for cancer patients.”