Immunotherapy Combination Promising for Metastatic Melanoma

For people with metastatic melanoma, treatment with a combination of Yervoy® (ipilimumab) and Leukine® (sargramostim; GM-CSF) may result in better overall survival than treatment with Yervoy alone. These results, from a Phase II clinical trial, were presented at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO).

Of the more than one million new diagnoses of skin cancer each year, roughly 68,000 involve melanoma. More than 8,000 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.

Immunotherapy refers to treatments that activate the immune system to attack cancer cells. Yervoy, a drug approved in 2011 for the treatment of advanced melanoma, targets a molecule known as CTLA4. CTLA4 is found on the surface of T cells and is thought to inhibit immune responses. Leukine is a growth factor that is used to increase white blood cells counts after chemotherapy or stem cell transplantation.

To evaluate the effect of adding Leukine to Yervoy, researchers conducted a Phase II clinical trial among 245 patients with metastatic melanoma [i]. Study participants were treated with either Yervoy alone or Yervoy in combination with Leukine.

  • Tumor shrinkage rates were similar in the two study groups.
  • Overall survival was better among patients who received combination treatment: 69% of patients treated with both Yervoy and Leukine survived for at least a year, compared with 53% of patients treated with Yervoy alone.
  • Combination treatment also resulted in fewer serious side effects.

These results suggest that that adding Leukine to Yervoy may improve both the efficacy and the safety of treatment for patients with metastatic melanoma.

Reference:

Hodi FS, Lee SJ, MCDermott DF et al. Multicenter, randomized phase II trial of GM-CSF (GM) plus ipilimumab (Ipi) versus ipi alone in metastatic melanoma: E1608. Presented at the 49th Annual Meeting of the American Society of Clinical Oncology. May 31-June 4, 2013; Chicago, IL. Abstract CRA9007.


[i] Hodi FS, Lee SJ, MCDermott DF et al. Multicenter, randomized phase II trial of GM-CSF (GM) plus ipilimumab (Ipi) versus ipi alone in metastatic melanoma: E1608. Presented at the 49th Annual Meeting of the American Society of Clinical Oncology. May 31-June 4, 2013; Chicago, IL. Abstract CRA9007.

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