Amgen revealed results of an interim pooled, blinded safety data from two phase III trials examining Vectibix (panitumumab) in combination with chemotherapy in first- and second-lines of metastatic colorectal cancer (mCRC) treatment.
The respective independent Data Monitoring Committee's reviews of the pooled, or combined, safety data from both arms of these randomised, multi-centre trials endorsed the continuation of these studies per protocol.
Vectibix was approved as a monotherapy in the United States in September 2006 for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
"We continue to make progress in elucidating the potential utility of Vectibix in the treatment of colorectal cancer," said David Chang, M.D., vice president, oncology clinical development, Amgen. "These phase III studies will provide important information about the efficacy of Vectibix when used in combination with conventional chemotherapy regimens."
The "PRIME" (Panitumumab Randomized trial In combination with chemotherapy for Metastatic colorectal cancer to determine Efficacy) or "203" trial is a global phase III study investigating Vectibix in combination with FOLFOX chemotherapy as a first-line treatment for patients with mCRC. Patients enrolled in the study were randomised to receive either 6.0 mg/kg of Vectibix and FOLFOX4 once every two weeks (Q2W) or FOLFOX4 alone Q2W. The primary endpoint is progression-free survival and other endpoints include overall survival, objective response rate, time to progression, duration of response and safety.
Vectibix is approved as a monotherapy for the treatment of patients with EGFr-expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix as a single agent for the treatment of EGFr-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. In December 2007, the European Medicines Agency (EMEA) granted a conditional marketing authorization for Vectibix as monotherapy for the treatment of patients with EGFr-expressing mCRC with non-mutated (wild-type) KRAS genes after failure of standard chemotherapy regimens. Regulatory applications in the rest of the world are still pending.