Amgen Announce Positive AMG145 Results & EU Approval for Vectibix

Amgen is the most recent drug maker to present data for a cholesterol drug that blocks the PCSK9 pathway.

Phase I data presented at the American Heart Association meeting in Orlando showed that a single dose of Amgen’s AMG145, a monoclonal antibody, reduced levels of low density lipoprotein or ‘bad’ cholesterol by up to 64% compared to placebo in healthy people.

The study randomised 56 people aged between 18-45 who did not have elevated cholesterol levels and were not taking other drugs, to receive a single injection or intravenous administration of one of five doses of AMG145 or placebo.

Amgen observed that with increasing doses of AMG145, blood tests revealed less of the active form of PCSK9, lower levels of bad cholesterol, total cholesterol and apo-B (the primary protein component of bad cholesterol). It also showed no effect on triglycerides, high density lipoprotein (“good” cholesterol) or a protein associated with good cholesterol.

Clapton Dias, medical sciences director of clinical pharmacology and early development at Amgen, noted that PCSK9 is the first target in lipid metabolism to be inhibited using a monoclonal antibody “and it appears to be a promising way to lower [LDL] cholesterol”. Speaking about the trial, he added that the more PCSK9 was lowered, “the more bad cholesterol levels went down. With higher doses, bad cholesterol stayed lower for a longer period.”

The US biotech major has some ground to make up on Sanofi and Regeneron’s REGN727, the organisation’s antibody which also blocks the PCSK9 pathway. Other companies testing anti-PCSK9 treatments include Pfizer, Merck & Co and Bristol-Myers Squibb.

Vectibix Granted EU Approval for Expanded Indications

Amgen have announced today that the European Commission have approved a variation to the marketing authorization for Vectibix to include indications for the treatment of patients with wild-type KRAS metastatic colorectal cancer 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).

The approval applies to all 27 European Union member states. Prior to this approval, Vectibix had received conditional approval in the EU as monotherapy.

Colorectal cancer is the second most common cancer in women internationally and the third most common cancer in men. Approximately 1.2 million cases of colorectal cancer are predicted to occur globally. With more than 630,000 deaths worldwide per year, it is the third leading cause of cancer-related death in the Western world.

Professor Jean-Yves Douillard, director of Clinical and Translational Research, ICO Centre R Gauducheau, France, commented that “colorectal cancer can have a devastating impact on the lives of patients affected by this disease.”  “This European Commission approval for Vectibix earlier in the treatment continuum marks a welcome and important addition of treatment choice in an area where few targeted agents have shown to be effective when used with chemotherapy.”

Data from studies 20050203 (PRIME) and 20050181 (‘181) showed that adding Vectibix to either FOLFOX or FOLFIRI chemotherapy improved progression-free survival versus chemotherapy alone. Additionally, the overall response rate of Vectibix plus chemotherapy was higher than chemotherapy alone.

The PRIME and ‘181 studies were among the first Phase 3 studies to prospectively analyse the effect of an anti-epidermal growth factor receptor (EGFR) inhibitor based on KRAS status in patients with metastatic colorectal cancer.

Willard H. Dere, M.D., senior vice president and international chief medical officer at Amgen, commented that “today’s decision by the EC to extend the therapeutic indications for Vectibix marks a promising step forward for those patients facing an aggressive disease where limited treatment options are available.”

Vectibix is already approved and established in over 40 countries as a monotherapy treatment for patients with wild-type KRAS metastatic colorectal cancer, when standard chemotherapy is no longer effective.


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