Keytruda® (pembrolizumab) continues to outperform Yervoy® (ipilimumab) as initial treatment of patients with advanced melanoma. Updated results of the KEYNOTE 006 trial presented at the 2017 annual meeting of the American Society of Clinical Oncology (ASCO) report that Keytruda is now associated with a 30% improvement in survival when used as initial treatment for advanced melanoma.

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 clinical trial known as KEYNOTE-006, has been investigating Keytruda directly 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).

Initial results of KEYNOTE 006 published in 2015 demonstrated that Keytruda was significantly more effective than Yervoy in both progression-free and overall survival. With these outcomes, Keytruda became 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.

In the longer-term findings presented at ASCO, treatment with Keyturda was associated with a continued 30 percent improvement in survival.  Overall 50 percent of patients treated with Keytruda were alive nearly three years after starting treatment compared to 39 percent of patients treated with Yervoy. In addition, Keytruda nearly doubled the rate of progression-free survival at 33.9 months: 31 percent of patients in the Keyturda group were alive and their disease had not progressed, compared to 14 percent of patients treated with Yervoy.

References:

  1. 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.
  2. http://abstracts.asco.org/199/AbstView_199_187297.html

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