Amgen skin cancer drug gets European approval
pharmafile | October 23, 2015 | News story | Research and Development | Amgen, Imlygic, melanoma, skin cancer
Amgen’s Imlygic (talimogene laherparepvec) has been approved by the scientific committee of the European Medicines Agency (EMA) for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.
If approved by the European Commission, as anticipated, Imlygic- which is administered via intralesional injection- would be the first in a class of novel agents known as oncolytic immunotherapies. The drug is based on a modified version of the cold sore virus, HSV-1, and destroys tumour cells by initiating an anti-tumour immune response.
“We are pleased that Imlygic has received a positive opinion from the CHMP, and if approved by the European Commission, we look forward to continuing to work with European regulatory authorities to bring this innovative therapy to patients,” says Sean Harper, executive vice president of research and development at Amgen.
“Metastatic melanoma continues to be one of the most difficult-to-treat cancers, often requiring the use of multiple treatment modalities. Despite recent advances, the five-year survival rate for patients who cannot be cured with surgery remains unacceptably low, demonstrating the critical need for additional approaches to control this disease.”
The positive CHMP opinion was based on a global, randomised, open-label Phase III trial evaluating the safety and efficacy of IMLYGIC in patients with Stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor.
In the 436-patient study, Imlygic was shown to significantly improve durable response rate (the percentage of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of six months).
A key secondary endpoint was overall survival (OS). The positive CHMP opinion reflects subgroup analyses where the effect on OS was largest in patients with unresectable melanoma that has not spread beyond the skin or lymph nodes.
The most commonly-reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness and injection-site pain. Overall, 98 percent of these adverse reactions reported were mild or moderate in severity. The most common grade 3 or higher adverse reaction was cellulitis.
Following this CHMP opinion, California-based Amgen expects a decision on the Marketing Authorisation from the European Commission in the coming months. Imlygic is also currently under review by the US Food and Drug Administration.
Joel Levy
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