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June 5 (Bloomberg) -- GlaxoSmithKline Plc’s combination of two experimental drugs for advanced melanoma helped almost all patients in its first human study, leading it to launch the therapy directly into large trials needed for U.S. approval.
The pills target two genetic variations that drive growth of melanoma, the deadliest skin cancer. Both drugs had been shown to help combat the disease in those with a mutation known as BRAF, found in about half of patients, though each carried side effects and had limited benefit when given separately.
All but one of 109 study patients tolerated full-strength doses of the combination and had fewer side effects, including rash, warts and milder forms of skin cancer, said Jeffrey Infante, director of drug development at the Sarah Canon Research Institute in Nashville. GlaxoSmithKline plans to move the combination directly into the final and third stage of testing generally required for regulatory approval, said Paolo Paoletti, president of London-based Glaxo’s oncology unit.
“The majority of patients have clinical benefit from the regimen, very quickly,” Infante said during a news conference at the American Society for Clinical Oncology meeting in Chicago, where the data was presented. “We have had five complete responders so far,” where the tumor, once easily visible studding the skin, disappears entirely, he said.
“You don’t have to be an oncologist to know you are helping people,” he said.
While the two drugs making up the new combination have helped patients individually, the gain isn’t long-lasting, Infante said. The goal of the mixing the two is to lengthen the time the disease can be kept at bay. The latest data didn’t cover a long enough time period to find that out, he said.
Cancer Cell Targets
One drug works by blocking BRAF, a mutation that spurs cancer cell growth. The other works by blocking a protein called MEK, which helps tumors resist an assault on BRAF.
The study included 109 patients, including 7 who didn’t have melanoma. The analysis didn’t include about 30 patients who were previously treated with a similar experimental drug that targets the BRAF mutation or hadn’t been in the study long enough to get a follow up scan. Of the remainder, 80 percent are still taking both drugs.
Melanoma strikes 68,000 Americans each year, according to the American Cancer Society. While patients with early stage disease respond well to treatment, the five-year survival rate for those with cancer that has spread is 15 percent.
Glaxo’s phase 3 trial will start by year end, Paoletti said. Details have not been finalized.
Paoletti said that Glaxo officials met with the U.S. Food and Drug Administration and also with European regulators “about a month ago” to discuss the possibility of moving two experimental drugs directly into phase 3 together.
”They are extremely interested” in the combination trial, he said in an interview. ”A few years ago this was not on the radar screen. The science is moving at the speed of light.”
The combination drug is just one of several promising candidates to help defeat skin cancer, said Stephen Hodi, director of the melanoma center at Dana-Farber Cancer Institute in Boston, in a telephone interview last month.
The Glaxo findings are the first in a wave of studies coming out at the meeting about malignant melanoma, which kills 8,700 Americans each year. Roche and Daiichi Sankyo Co. of Tokyo, will provide additional data on their similar BRAF inhibitor, dubbed vemurafenib, while Bristol-Myers Squibb Co. will outline the benefits of its immune therapy Yervoy.
Yervoy was the first drug to show a survival benefit for patients with metastatic melanoma when it was approved in March. The companies said Thursday they are doing a combination trial of the two drugs to see if they can further improve results.
Billions in Sales
Success in melanoma also may lead to billions of dollars in sales for drugmakers. New York-based Bristol-Myers’s Yervoy, the first to extend advanced melanoma survival when it was approved March 25, costs $120,000 for a standard course of four doses and may reach $1.5 billion in sales by 2015, according to Bloomberg survey of four analysts.
“This is clearly the year of melanoma,” said George Sledge, Jr., president of the American Society of Clinical Oncology and oncology professor at Indiana University’s Cancer Center in Indianapolis, in an interview. “Metastatic melanoma is desperately awful in terms of prognosis, and we’ve had no real survival advantage in 30 years. This I think is a real sea change.”
--Editors: Angela Zimm, Reg Gale
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