Amgen (AMGN) Announces Additional Data from Vectibix in mCRC; Increased OS Observed

October 10, 2016 9:11 AM EDT

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Amgen (Nasdaq: AMGN) announced results from new retrospective analyses of key studies with Vectibix (panitumumab) in metastatic colorectal cancer (mCRC) patients. The retrospective analysis of the PEAK study in mCRC patients with RAS wild-type primary tumors of left-sided origin showed that patients receiving Vectibix plus FOLFOX6 as first-line treatment achieved 43.4 months median overall survival (OS), an increase of 11.4 months when compared to FOLFOX6 plus bevacizumab. Additionally, for this patient population, the retrospective analysis of the PRIME study showed Vectibix plus FOLFOX4 increased OS by 6.7 months when compared to FOLFOX4 alone. These data were presented today at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen (Abstract #89P).

The PEAK and PRIME retrospective analyses, respectively, also showed that mCRC patients with RAS wild-type tumors of left-sided origin receiving Vectibix plus FOLFOX chemotherapy achieved median progression-free survival (PFS) of 14.6 months, an increase of 3.1 months when compared to FOLFOX plus bevacizumab, and 12.9 months, an increase of 3.7 months when compared to FOLFOX chemotherapy alone.

The retrospective analyses found that approximately 80 percent of tumors originate in the left side of the colon. Additionally, tumors originating in the right side of the colon are currently associated with a poorer prognosis than tumors originating in the left side of the colon. In patients with RAS wild-type mCRC with tumors originating on the right side, a subgroup of patients responded to Vectibix and chemotherapy, achieving numerically higher response rates over chemotherapy with or without bevacizumab. However, no final conclusions can be made regarding the ability to differentiate treatment regimens for patients with right-sided tumors. The safety profile of the use of Vectibix in combination with FOLFOX-based chemotherapy in mCRC has been previously reported (see summary of EU product safety information below). The aggregate safety data is unchanged by this retrospective analysis of outcomes based on CRC tumor site of origin.

"Data from these retrospective analyses are helping Amgen make important connections between tumor biology and treatment outcomes," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Tumor sidedness is a surrogate for differences in tumor biology and mutation load, potentially providing physicians with another means to help inform the treatment decisions for patients with metastatic colorectal cancer."

Colorectal cancer is the second most common cancer in women and the third in men worldwide, with approximately 1.4 million new cases occurring globally each year. In Europe, it is the second most common cancer, with more than 470,000 new cases each year.1 Approximately 80 percent of all colorectal cancers originate in the left side of the colon and 20 percent originate in the right side.2

Abstracts are currently available on the ESMO website.



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