European approval for Amgen cancer drug Imlygic
pharmafile | December 18, 2015 | News story | Sales and Marketing | Amgen, European Commission, Imlygic, melanoma, skin cancer, t-vec, talimogene laherparepvec
The European Commission has approved the use of Amgen’s Imlygic for adults with advanced melanoma, making it the first drug in its class to be approved in the European Union.
Imlygic (talimogene laherparepvec) is approved for people whose tumour is unresectable and regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral disease.
It is an oncolytic immunotherapy derived from the herpes (cold sore) virus, which has been modified to replicate within cancer tumours and stimulate an immune response, causing the death of tumour cells. It is the first in this class of therapy to demonstrate therapeutic benefit for patients with metastatic melanoma in a Phase III clinical trial.
Sean Harper, executive vice president of research and development at Amgen, says: “As the first oncolytic immunotherapy authorised in the European Union, the approval of Imlygic is an important milestone for this new class of drugs, bringing patients with a rare and deadly form of skin cancer a much needed new treatment option. By igniting the body’s own immune system, Imlygic can initiate an anti-tumour immune response, providing meaningful and durable response rates in the early stage metastatic melanoma patient.”
There are an estimated 22,000 deaths from melanoma in the EU each year. While the disease is curable when detected in the early stages, metastatic melanoma continues to be one of the most difficult-to-treat cancers, due to its highly aggressive and complex nature. Even with recent new options in immune-oncology, a large number of patients with metastatic melanoma still do not respond to treatment.
The Commission approved Imlygic based on a review of exploratory subgroup analyses of the OPTiM study, in which the drug showed a durable response rate (DRR) in 25.2% of patients with Stage IIIB, IIIC and IVM1a disease. It came after the drug was recommended by the EMA, just days before it was approved in the US by the FDA. In the study, patients with Stage IIIB, IIIC and IVM1a disease achieved an overall response rate (ORR) of 40.5% and a median overall survival rate of 41.1 months.
Professor Kevin Harrington, professor of biological cancer therapies at The Institute of Cancer Research London, and consultant at The Royal Marsden – who led the UK-arm of the T-VEC Phase III trial, says he is ‘really excited’ by the decision.
“Today [Imlygic has] become the first viral immunotherapy to gain a licence in Europe, and is not only effective but also has relatively mild side-effects compared with other types of immunotherapy on the market.
“It is an important first step that paves the way for it being made available for patients with metastatic melanoma – a cancer that has largely been regarded as untreatable for the majority of patients. NICE has already started evaluating the treatment, and I hope there are no delays in making it available to patients on the NHS.”
Joel Levy
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