Roche, Bristol-Myers Melanoma Therapies Lead to Longer Lives

An experimental drug from Roche Holding AG and Daiichi Sankyo Co. boosted survival of patients with melanoma in a study, a result that may lead to a second new treatment to fight deadly skin cancer.

The treatment, vemurafenib, slashed death risks by 63 percent in advanced melanoma patients with a gene mutation carried by half of those with the disease, according to a report today at the American Society of Clinical Oncology meeting in Chicago. If cleared for sale, vemurafenib -- from Basel, Switzerland-based Roche, and Daiichi, of Tokyo -- would compete with Bristol-Myers Squibb Co.’s Yervoy, approved in March.

Yervoy may reach $1.5 billion in sales by 2015 while vemurafenib may generate $796 million, analysts have said. These two drugs may be heralds to a revolution in treating melanoma, which kills 8,700 Americans a year, and has long challenged efforts to develop an effective treatment. The new medicines are followed by at least a dozen more in advanced testing.

“The field of metastatic melanoma treatment is moving faster these last two years than in all the past several decades,” said Antoni Ribas, an oncologist at the University of California in Los Angeles.

The plethora of new drugs will also provide opportunities to combine treatments that could further improve the prognosis for patients, with an initial trial combining Yervoy and vemurafenib slated to start later this year, said Patrick Hwu, chair of melanoma oncology at M.D. Anderson Cancer Center in Houston, in an interview.

“One drug has an excellent response, but a short duration of benefit,” Hwu said in an interview. “The other has a miraculous response in just a few patients. Hopefully by combining them we can get the best of both worlds.”

Glaxo Drug Combination

GlaxoSmithKline Plc is starting studies needed for approval of its combination of two novel drugs, after the cocktail helped almost all of the patients in its first human trial, said Paolo Paoletti, president of London-based company’s oncology unit.

In the vemurafenib trial, 675 patients with advanced melanoma who had a mutation in a gene called BRAF received either the experimental drug or chemotherapy. The BRAF gene mutation drives the disease in about half of patients with advanced skin cancer.

After six months, 84 percent of the patients taking vemurafenib were still alive, compared with 64 percent of the patients who got chemotherapy, according to results that were also published today in the New England Journal of Medicine.

The difference was so striking that researchers stopped the trial early before median survival had been calculated. The drug shrank tumors in 48 percent of patients compared with 5 percent for those on chemotherapy. Earlier studies suggest tumors develop resistance to the drug in about seven months.

Yervoy Study

In a second trial presented at the meeting and published in the journal, led by researchers from Memorial Sloan-Kettering Cancer Center showed that New York-based Bristol-Myers’ Yervoy improved survival when given with chemotherapy as an initial treatment by a median of 2.1 months. The drug has previously been proven to extend survival in patients who failed previous therapy.

While not everyone responds to treatment, those who do can benefit for years, studies show. Almost half of patients taking Yervoy with the chemotherapy dacarbazine were alive after a year, compared with one-third given the chemotherapy alone. Twenty-one percent of patients taking Yervoy survived at least three years, compared with 12 percent on dacarbazine only.

If the trend toward better survival continues, some melanoma patients may live as long as their healthy peers, said Renzo Canetta, vice president of oncology clinical research, said in an interview.

Side Effects

The new medicines weren’t without side effects. Patients taking vemurafenib reported joint pain, diarrhea, and headaches. There was also had a higher incidence of another less serious type of skin cancer called squamous-cell carcinoma.

Yervoy can cause life-threatening inflammation of the intestines and other organs. In the Yervoy trial presented today, researchers reported a lower rate of the most serious types of these side effects than had been seen previously.


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