GHP October 2016

8 | ghp October 2016 Data on Amgen’s Vectibix® Presented at ESMO 2016 New Retrospective Analyses Confirm Vectibix® (Panitumumab) Treatment Provided Survival Benefit Over Chemotherapy with or Without Bevacizumab in Metastatic Colorectal Cancer Patients with Tumours of Left-Sided Origin Additionally, for this patient population, the retrospec- tive analysis of the PRIME study showed Vectibix plus FOLFOX4 increased OS by 6.7 months when com- pared to FOLFOX4 alone. These data were presented 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 tumours 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 chemother- apy alone. The retrospective analyses found that approximately 80% of tumours originate in the left side of the colon. Additionally, tumours originating in the right side of the colon are currently associated with a poorer prognosis than tumours originating in the left side of the colon. In patients with RAS wild-type mCRC with tumours 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 regard- ing the ability to differentiate treatment regimens for patients with right-sided tumours. 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 tumour site of origin. “Data from these retrospective analyses are helping Amgen make important connections between tumour biology and treatment outcomes,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Tumour sidedness is a surrogate for differences in tumour 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% of all colorectal cancers originate in the left side of the colon and 20% origi- nate in the right side.2 Abstracts are currently available on the ESMO website, here: http://www.esmo.org/Conferences/ES- MO-2016-Congress/Abstracts Amgen on 10th October announced results from new retrospec- tive 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 tumours 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. news

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