Thursday, biotechnology company Amgen Inc. (AMGN), said its KRAS wild-type metastatic colorectal cancer or mCRC experimental drug Vectibix in combination with Folfox failed to meet secondary endpoint of overall survival in its prime 203 trial.
The analysis of the company's prime 203 trial showed that Vectibix in addition to a Folfox chemotherapy regimen in patients with metastatic colorectal cancer, or mCRC, resulted in a median overall survival of 23.9 months compared with 19.7 months for patients treated with Folfox alone, the difference of 4.2 months did not reach the statistical significance.
Commenting on the results, Roger Perlmutter executive vice president of Research and Development said, "As we previously announced, the 203 study met its primary endpoint of progression-free survival in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer."
The results showed overall survival appeared to be reduced in patients with KRAS mutant tumors receiving Vectibix. Though not statistically significant, the result emphasizes the importance of ensuring that patients receiving Vectibix do not bear tumors containing KRAS mutations.
Vectibix, the first human anti-EGFR antibody, was approved by the U.S. Food and Drug Administration in September 2006 for the treatment of mCRC. Vectibix was 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.
Patients enrolled in the trial were randomized to receive either 6.0 mg per kg of Vectibix and Folfox4 once every two weeks or Folfox4 alone once every two weeks.
Colorectal Cancer is a leading cause of cancer-related death in the Western world with highest incidence rates found in Japan, North America, parts of Europe, New Zealand, and Australia.
Thursday, AMGN closed at $54.05, up $1.93 or 3.70% on the Nasdaq.
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