Amgen, a biotechnology company developing innovative human therapeutics, has announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for talimogene laherparepvec as a treatment for adults with melanoma that is regionally or distantly metastatic.
Melanoma is the most aggressive type of skin cancer, accounting for 132,000 new cases every year worldwide, and with numbers expected to increase to 279,000 by 2020.
Disease outcomes are significantly worse for patients diagnosed with regional and distantly metastatic disease, a stage where cancer cells from the primary tumor site have already spread to other organs such as the lymph nodes or lungs, carrying a particularly high risk of recurrence for Stage IIIB, IIIC, and IV melanoma.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to specifically replicate in tumors but not in healthy, normal tissue. This leads to an immune response directed towards cancer cells that have acquired the capacity to metastasize. This drug is injected directly into the tumor microenvironment, were it can multiply and induce tumor cells to burst and die, causing them to release tumor-derived antigens, along with granulocyte macrophage colony stimulating factor (GM-CSF). This in turn stimulates a systemic immune response responsible for the targeting and elimination of cancer cells that have already spread throughout the body.
The MAA for talimogene laherparepvec is based on data from a global, randomized, open-label, Phase 3 trial evaluating the safety and efficacy of talimogene laherparepvec compared to control GM-CSF therapy in more than 400 patients diagnosed with stage IIIB, IIIC or IV melanoma when surgical resection was not recommended.
Patients were randomized to receive either talimogene laherparepvec intralesionally every two weeks or GM-CSF subcutaneously for the first 14 days of several 28-day cycles. The results showed that among the 26% of patients who achieved an overall response in the talimogene laherparepvec arm, 40% achieved a complete response. Furthermore, significant improvement in durable response rate was observed in 16% of the talimogene laherparepvec arm versus 2% in the controls.
“The submission of the Marketing Authorization Application in Europe for talimogene laherparepvec brings us a step closer to helping address an unmet medical need for patients with metastatic melanoma. This regulatory milestone, on the heels of our Biologics License Application submission to the U.S. FDA, represents an important step for our pipeline and we look forward to working with the European Medicines Agency as it conducts its review of talimogene laherparepvec.” Sean E. Harper, M.D., executive vice president of Research and Development at Amgen said in a company’s press release.