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Stage III, Unknown Primary; 1 positive node in left axilla
Drug Firms Focus on Advanced Melanoma
By Hester Plumridge
March 23, 2014 8:11 p.m. ET
Major pharmaceutical companies are racing to launch breakthrough drugs in the next 18 months to treat advanced melanoma, the deadliest form of skin cancer.
Bristol-Myers Squibb Co. BMY +0.86% Bristol-Myers Squibb Co. BMY in Your Value Your Change Short position , Roche Holding AG ROG.VX in Your Value Your Change Short position and Merck MRK in Your Value Your Change Short position & Co. each are working on a potential blockbuster "immunotherapy" drug that would use the body's immune system to fight the cancer. If approved, the three drugs could be launched between late 2014 and late 2015. AstraZeneca AZN.LN in Your Value Your Change Short position PLC has an earlier-stage candidate in development.
The drugs are among the biggest pipeline hopes for all four companies. Merck started filing its candidate MK-3475 with U.S. regulators in January and expects to complete the process by July, opening up an unexpected lead on competitors. It already has a dedicated business unit set up to market the drug.
"In cancer, it's always good to come to market first," says Eric Rubin, vice president of oncology research at Merck Research Laboratories. Launching before rivals can help a company set higher prices and get its drug better-known among physicians.
Analysts believe Bristol-Myers may be farthest ahead in trials for its drug nivolumab for lung cancer, a disease with roughly 10 times as many patients as advanced melanoma. The new drug candidates are also being investigated in lung, breast, renal, blood and many other cancers.
Bristol-Myers and Roche also have more potential to approve the drugs in combination with their existing treatments, boosting revenue. Merck signed a number of agreements to test MK-3475 with drugs from rival companies last month.
Early-stage melanoma is often operable, but advanced melanoma is aggressive and usually deadly. Average survival without treatment is just a few months. The disease kills around 9,500 people in the U.S. annually.
Bristol-Myers's first immunotherapy drug, Yervoy, was launched in 2011 and radically altered the outlook for sufferers. In a recent company-led analysis of 12 studies, 22% of patients were still alive three years after taking it and some survived for more than 10 years. But Yervoy is effective only in a limited subset of patients, and there is no way of telling who will benefit. It also has substantial toxicities.
Turning a terminal disease into a chronic one is hard to put a price on, and payers have so far been willing to spend on treatments with radical efficacy. Yervoy costs $120,000 for a course of four injections, which is often all a patient needs.
The new drugs target a different protein called PD-1, or programmed cell-death 1, which binds to another substance called PD-L1 to act as a brake on the immune system. Cancer cells can latch onto PD-1 to escape detection by the body, but the new drugs help turn the immune response back on.
"We know the immune system is very effective at killing intruders," says Niko Andre, Roche's medical director of oncology. "But we've never really managed to control it in a safe and sophisticated way before."
In one trial of MK-3475 in advanced melanoma, 41% of patients saw their tumors shrink, and a similar response rate was seen in a separate trial combining Bristol-Myers's drugs nivolumab and Yervoy.
Roche, Merck and Bristol-Myers say it is too early to comment on the potential cost of the PD1s, but Citigroup C in Your Value Your Change Short position thinks they could cost up to $240,000 a year. Unlike Yervoy, they could be used for one to two years, or even as chronic therapies.
Competition is expected to bring costs down as a number of drugs launch in coming years. But doctors say immunotherapies are likely to be most effective when they are used in combination, either with other biologic drugs or with radiation. That could spark a debate over pricing.
"With combinations, pricing could quickly become completely unsustainable," says Paul Workman, deputy chief executive of the U.K.-based Institute of Cancer Research.
"We're seeing unprecedented patient responses with some of these drugs," says Antoni Ribas, a professor of medicine at the University of California, Los Angeles, who worked on MK-3475 trials. "The hope is that they will have fewer side effects than Yervoy, work in larger subsets of people, and that it will be much easier to work out who those people are."
Advanced melanoma's high mutational rate may help it respond better to immunotherapies, but by 2025, immunotherapies will be the dominant treatment for all advanced cancers, estimates Andrew Baum, Citigroup's head of global health care. He predicts a market eventually exceeding $35 billion.
Analysts expect peak annual sales from the new drugs of around $6.4 billion for Bristol-Myers, $3.4 billion for Merck and $2.7 billion for Roche, according to a recent ISI Group survey.
Acute medical need has attracted competition, with five PD-1 or PD-L1 drugs in clinical trials. Trials may require only a few hundred patients, rather than several thousand for a cardiovascular drug. Cancer drugs enjoy high success rates when submitted to regulators, and breakthrough treatments get swift consideration.
"MK-3475 has been the fastest-developed compound during my time at Merck," says Dr. Rubin. "From the first time we tested it in man to regulatory filing was less than three years." Traditionally, that would be more like eight years.
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