Nathan Schwegman was just 25 when his doctor told him he had a 3 percent chance of surviving the melanoma that had spread into his lungs and spine, soon leaving him in so much pain he could hardly move.
A month later, in January 2012, he enrolled in a clinical trial testing a new drug from Merck (MRK) & Co. that was designed to rev up his immune system to attack and kill his cancer. In just two months, the pain started going away. Now he’s cancer free.
“Even some of my doctors were like ‘this is a miracle’” said Schwegman, who lives in Irvine, California and runs a nonprofit ministry that counsels troubled kids. Without the drug, “I probably would not be here.”
The next generation of experimental immune-boosting drugs from Merck, Bristol-Myers Squibb Co. (BMY) and Roche Holding AG are producing such promising early results that doctors at the American Society of Clinical Oncology meeting in Chicago are openly speculating that some patients with the deadliest form of skin cancer may be cured.
Merck rose 3.8 percent to $48.45 at the close in New York. Bristol-Myers gained 3.4 percent to $47.59.
In 2011, Yervoy from New York-based Bristol-Myers became the first drug to extend life for melanoma patients. Since then, it’s been joined on the market by three other new melanoma drugs, including two from London-based GlaxoSmithKline Plc (GSK) approved by U.S. regulators in May. A half-dozen more are in mid-to-late stage clinical testing, researchers said.
The advances are moving so rapidly that “we’re throwing out the textbooks,” said Jedd Wolchok, a melanoma expert at Memorial Sloan-Kettering Cancer Center in New York. “What I tell patients is what they hear or read about survival in melanoma is already outdated.”
Years of Life
Doctors used to say the average life expectancy for final-stage melanoma was about 9 months, said Lynn Schuchter, an oncologist at Abramson Cancer Center of the University of Pennsylvania. With the new immunotherapies, patients “are often living many years,” she said.
While Yervoy, the first immune system drug approved to fight melanoma, has only been shown to shrink tumors in slightly more than 10 percent of patients, the patients who gain from it tend to live a long time because the immune system is adaptable and can keep up with mutations in the tumor.
The new immune therapy drugs in testing at Whitehouse Station, New Jersey-based Merck, Bristol-Myers, and Basel, Switzerland-based Roche (ROG) are aiming to increase the number of patients whose tumors shrink. They work to prevent the flicking of an off-switch called PD-1 on immune T-cells, a key defender against attacks by dangerous germs and infections. Investors are closely watching the results as the new class of drugs has the potential to reap billions of dollars in sales.
In early studies, the PD-1 drugs have produced higher rates of long-lasting tumor shrinkage than Yervoy, often with fewer side effects, said Antoni Ribas of the University of California, Los Angeles, who has tested the Merck drug.
At the oncology meeting, Ribas presented results of an initial study showing that the Merck drug, lambrolizumab, shrunk tumors dramatically in 38 percent of 135 advanced melanoma patients, including a 52 percent tumor shrinkage rate at the highest dose.
The vast majority of the patients whose tumors shrunk were continuing to respond to the drug the last time they were checked, he said in an interview. Ribas said that he had seen an “amazingly high” number of patients with long-lasting responses to the Merck treatment.
In a separate small study presented at the meeting, Wolchok reported that 82 percent of 53 patients who were given a combination of the experimental medicine nivolumab from Bristol-Myers and Yervoy were alive after a year, a far higher rate than is seen with Yervoy alone.
The drug combination reduced tumors in 40 percent of patients. Almost all of the patients who responded to the medicine remain in remission, according to the results, which are also being published in the New England Journal of Medicine.
Mario Sznol of Yale Cancer Center, who presented data from another trial of Bristol-Myers’ nivolumab drug at the conference, said he had two patients who started on the medicine more than four years ago and remain in remission today.
“I do think some of the people are cured,” he said at the conference. Overall, the patients who got nivolumab in his trial lived a median of 16.8 months, compared to a 10 month median survival in a previous big trial of Yervoy, he said.
Immune-boosting drugs have potential far beyond melanoma to treat a large number of tumor types, said Sean Harper, head of research and development for Amgen (AMGN) Inc.
Amgen is testing an anti-cancer virus therapy that produced tumor shrinkage in 26 percent of advanced melanoma patients, according to results presented at the oncology meeting.
The drug may have a synergistic effect when combined with antibodies such as the ones being tested at Merck and Bristol-Myers. Antibodies and viruses target the immune system in different ways, Harper said.
Immune boosting drugs “will become over time a cornerstone of therapy for many tumor types,” said Harper in a phone interview. “It has really come of age in a very dramatic way this year.”
Merck is already testing its drug in lung, breast, bladder and head and neck cancers.
“This is a top priority at Merck,” said Gary Gilliland, Merck senior vice president, at a meeting for analysts at the cancer meeting. “We have our best people working on it, our best teams. We are going flat out.”
So far, the highest response rates to the PD-1 drugs have been seen in melanoma. Both Bristol-Myers and Merck are starting final-stage trials comparing their immune therapy drugs to Yervoy. Bristol-Myers’ trial will also test the combination of nivolumab and Yervoy.
Melanoma patients aren’t waiting for the big trials to finish. Some people are jetting thousands of miles to gain access to the experimental PD-1 drugs.
Henrik Madsen, a 62-year-old project director at a Danish shipping company, travels every three weeks from his home near Copenhagen to Ribas’s clinic at UCLA to get the Merck PD-1 drug for his melanoma that spread to his chest after numerous other treatments failed.
Since he started the therapy last October, his tumor has shriveled by 90 percent. The main side effect was been fluid accumulation in the lungs that needed to be drained and required him to miss one dose.
Madsen, who has suffered from melanoma for a decade, said he is hopeful his tumor will keep shrinking and that in a few months can stop treatment entirely. For the first time in years, he is able to plan vacations with his wife, he said.
“We do not call my disease a fatal disease any longer, we call it a chronic disease,” he said in a phone interview. “It is really exciting to look on the bright side of life.”
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