Keytruda® (pembrolizumab) appears to outperform Yervoy® (ipilimumab) at initial treatment of patients with advanced melanoma. Pharmaceutical company Merck announced these Phase III clinical trial findings in a press release in March 2015.
Melanoma is less common than non-melanoma skin cancer, but tends to be much more aggressive. What makes melanoma so dangerous is that it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body. Melanoma can occur anywhere on the body. The first signs of melanoma may be a mole that changes in appearance, bleeds, or has more than one color or an irregular shape.
Keytruda works by blocking the action of a protein called PD-1. Because PD-1 inhibits certain types of immune responses, drugs that block it may enhance the ability of the immune system to fight cancer. In earlier studies Keytruda has demonstrated anticancer activity in advanced melanoma, including disease that has progressed with other therapy.
A recent Phase III study, known as KEYNOTE-006, has been investigating Keytruda compared with Yervoy as first-line treatment of patients with advanced melanoma that can’t be removed with surgery. Yervoy is a monoclonal antibody approved for the treatment of advanced melanoma. It may enhance the immune system’s response against tumor cells and was approved in 2011 for the treatment of melanoma that has spread to other sites or cannot be surgically removed. The 834 patients included in KEYNOTE-006 had no more than one previous systemic therapy (such as chemotherapy or biological agents).
Keytruda appeared significantly more effective than Yervoy in both progression-free and overall survival. With these outcomes, Keytruda is the first anti-PD-1 therapy to demonstrate a survival advantage compared to the standard of care for the first-line treatment of advanced melanoma. Keytruda appeared so much more effective than Yervoy (and acceptably tolerable and safe) that the study’s independent Data Monitoring Committee has recommended that the KEYNOTE-006 trial be stopped early.
According to Dr. Roger Perlmutter, president, Merck Research Laboratories, Keytruda’s strong performance against advanced melanoma will help guide future treatment. “Evidence from our clinical program for Keytruda will help to define the appropriate treatment of advanced melanoma,” he said.
Reference: Merck’s Pivotal KEYNOTE-006 Study in First-Line Treatment for Advanced Melanoma Met Co-Primary Endpoints and Will Be Stopped Early [press release]. Merck website. Available at: http://www.mercknewsroom.com/news-release/oncology-newsroom/mercks-pivotal-keynote-006-study-first-line-treatment-advanced-melano. Accessed April 8, 2015.
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