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New Amgen data in melanoma and metastatic colorectal cancer to be presented at ESMO 2016 Congress
Thousand Oaks, California | Friday, October 7, 2016, 13:00 Hrs  [IST]

Amgen announced that new data on Imlygic (talimogene laherparepvec) in combination with an immune checkpoint inhibitor and results from retrospective analyses on Vectibix (panitumumab) will be presented at the European Society for Medical Oncology (ESMO) 2016 Congress, October 7-11, 2016, in Copenhagen.

Imlygic presentations include interim results from a phase 2 trial evaluating Imlygic in combination with ipilimumab versus ipilimumab alone in patients with unresected stage IIIB-IV melanoma. Vectibix abstracts include retrospective analyses of the first-line phase 3 PRIME and PEAK studies, evaluating the association between tumour site of origin and treatment efficacy in patients with RAS wild-type metastatic colorectal cancer (mCRC).

"We look forward to sharing our research into the combination of a checkpoint inhibitor and Amgen's oncolytic immunotherapy in metastatic melanoma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Additionally, we are excited about our data around tumour site of origin as one of a number of potential factors that may inform treatment decisions for patients with metastatic colorectal cancer."

Imlygic is an oncolytic immunotherapy that is derived from HSV-1, which is commonly called the cold sore virus. Imlygic has been modified to replicate within tumours and to produce the immune stimulatory protein human GM-CSF. Imlygic causes the death of tumor cells and the release of tumour-derived antigens. It is thought that, together with GM-CSF, it will promote a systemic anti-tumour immune response and an effector T cell response.

Vectibix is a fully human anti-epidermal growth factor receptor (EGFR) antibody approved by the European Medicines Agency (EMA) for the treatment of mCRC. The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment. Vectibix was approved in Europe in December 2007 as a monotherapy for the treatment of patients with EGFR-expressing mCRC with non-mutated (wild-type) KRAS genes after failure of standard chemotherapy regimens.

In April 2015, the European Commission (EC) approved a new use of Vectibix as first-line treatment in combination with FOLFIRI for the treatment of adult patients with RAS wild-type mCRC. In November 2011, the EC expanded the marketing authorization to include indications for the treatment of patients with KRAS wild-type mCRC in first-line in combination with FOLFOX and in second-line in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

Globally, over 240,000 patients have been treated with Vectibix and more than 6,000 patients have participated in Amgen-sponsored panitumumab clinical trials.

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