Recent findings reported in The Lancet indicate that the investigational drug pembrolizumab may be effective in patients with advanced melanoma that has progressed after treatment with Yervoy® (ipilimumab).[1] These findings build on previous research showing promise for pembrolizumab in advanced melanoma.

Of the more than one million new diagnoses of skin cancer each year, roughly 76,000 involve melanoma. More than 9,000 people die of melanoma each year in the United States. Melanoma is dangerous because it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body. Yervoy is an immunologic therapy that can be effective against advanced melanoma; patients whose disease progresses on Yervoy, however, may have limited treatment options.

Pembrolizumab is a drug known as an anti-PD-1 drug. These drugs are designed to block PD-1, a protein that inhibits certain types of immune responses. Drugs that block PD-1 may enhance the ability of the immune system to fight cancer.

Pembrolizumab has already shown promising results in patients with advanced melanoma. In 2013, researchers with a Phase I study reported that the drug effectively shrank tumors in almost 40% of participants and that these responses showed promise of continuing.[2],[3]

These latest positive results for pembrolizumab were based on a cohort study of the Phase I trial. Researchers assessed two different doses of pembrolizumab among patients with advanced melanoma that had progressed after Yervoy: 2 mg/kg and 10 mg/kg every three weeks.

A total of 173 patients were included in the study; 89 received the 2 mg/kg dose, and 84 received the 10 mg/kg dose.

  • At an eight-month median follow-up, 26% of patients in both dosage groups had responded to pembrolizumab, meaning that disease had not progressed and/or tumors had shrunk.
  • Both groups also tolerated the treatment well, with fatigue, itching, and rash being the most common reported side effect; none tended to be severe.

With two different doses of pembrolizumab appearing effective, these findings help researchers build on their understanding of how this drug may be used against advanced melanoma that has progressed after Yervoy—an instance where additional treatment options are very much in need.


[1] Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. The Lancet [early online publication]. July 15, 2014.

[2] Ribas A, Robert C, Daud A, et al. Clinical efficacy and safety of lambrolizumab (MK-3475, Anti-PD-1 monoclonal antibody) in patients with advanced melanoma. Presented at the 49th Annual Meeting of the American Society of Clinical Oncology. May 31-June 4, 2013; Chicago, IL. Abstract 9009.

[3] Hamid O, Robert C, Daud A, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. New England Journal of Medicine [early online publication]. June 2, 2013.

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