Bloomberg News

Glaxo Two-Drug Melanoma Combo Slows Cancer in Study

September 29, 2012

GlaxoSmithKline Plc (GSK)’s combination of two experimental melanoma medicines slowed the cancer’s progress longer than a single-drug treatment, a study found.

Patients taking Glaxo’s dabrafenib and trametinib together delayed tumors from progressing for 9.4 months, compared with 5.8 months for patients taking dabrafenib alone, according to the study of 162 patients. The trial was part of the second of three phases of human testing usually required by regulators.

Dabrafenib works by blocking BRAF, a mutant gene that spurs cancer-cell growth in about half of melanoma patients, while trametinib thwarts a related protein called MEK, which helps tumors resist an assault on BRAF. The study, funded by London- based Glaxo, was released today at the European Society for Medical Oncology meeting in Vienna and simultaneously published in the New England Journal of Medicine.

“The BRAFi/MEKi combo will attain a dominant position in the BRAF-mutant melanoma setting,” Andrew Baum, an analyst at Citigroup Inc. in London, said in a report earlier this week.

The company has begun a late-stage study of the combination therapy. On Aug. 3, Glaxo said it submitted the medicines individually to regulators in the U.S. and Europe for approval. If cleared for marketing, they would compete with Roche Holding AG’s Zelboraf, a targeted therapy approved last year for sale in the U.S.

The study tested two doses of trametinib. Among patients who received both drugs at the higher dose, 41 percent hadn’t progressed 12 months after treatment began, compared with 9 percent in the single-drug arm of the study.

Side Effects

In an early-stage study presented in May, patients taking the two medicines together had a lower incidence of rash and skin lesions than previously reported with Roche (ROG)’s Zelboraf.

Adding the MEK drug may reduce a signature side effect of BRAF drugs like Zelboraf -- the development of non-melanoma skin cancer -- while possibly boosting efficacy, according to Jeffrey Weber, a study leader and oncologist at the H. Lee Moffitt Cancer Center in Tampa, Florida.

About 15 to 30 percent of melanoma patients treated with Zelboraf and other BRAF inhibitors develop non-melanoma skin cancers, scientists at the Institute of Cancer Research said in an article published in the New England Journal of Medicine in January. The drugs speed a type of skin malignancy known as squamous-cell carcinoma in patients who may have gotten the cancer anyway, they said.

Melanoma will strike more than 76,000 Americans this year, according to estimates from the National Cancer Institute. While patients with early stage disease respond well to treatment, the five-year survival rate for those with cancer that has spread is about 15 percent, according to the American Cancer Society.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net


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