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Melanoma drug shows promise for lung cancer
April 20, 2015

By San Antonio Express-News - from staff and wire reports

A simple protein test can help identify lung cancer patients who are likely to respond to Merck & Co.'s melanoma drug Keytruda, a trial has found.

Based on the findings, Merck has applied for U.S. Food and Drug Administration approval for the drug in lung cancer patients who have failed other therapies, Merck research chief Roger Perlmutter said in an interview. Keytruda already is approved for treating advanced melanoma.

Keytruda has an established history here in San Antonio, where researchers with South Texas Accelerated Research Therapeutics were the first to show the medication can be an effective treatment for both illnesses.

"We were the first people to work with this drug globally," said Dr. Amita Patnaik, START's associate director of clinical research and a medical oncologist. "No one had had prior experience in the administration of this drug to human beings.

"We were really the first to get exposure to this molecule and to be able to describe its safety - and also to be able to describe its activity in both melanoma and lung cancer."

So far, 59 patients have undergone one of several clinical trials with the medication at START's offices in San Antonio, according to figures provided by Patnaik. The collective number of patients nationwide undergoing trials with the drug is much larger.

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Abelardo Torres, 75, of San Antonio, said taking the drug through one of START's clinical trials has helped him tremendously. He was diagnosed with metastatic lung cancer in December 2013.

Initially, Torres was told he had only two weeks to two months to live. After taking the medication for 15 months, his tumor has shrunk by 96 percent, START officials said.

"There's no question it saved my life," Torres said Monday. "I was in the right place at the right time ... for the right medicine."

Keytruda received accelerated approval from the U.S. Food and Drug Administration in September for use in patients with advanced melanoma who failed to respond to other medications. Findings presented Sunday at a cancer research conference opened a door of possibilities for lung cancer patients as well.

According to a report unveiled at the American Association for Cancer Research meeting in Philadelphia, researchers - including Patnaik from START - found advanced lung cancer patients with high levels of a specific protein in their tumors were far more likely to experience substantial tumor shrinkage after being treated with Merck's drug than those with lower levels of the protein. The findings also were published in this month's New England Journal of Medicine.

Almost 500 lung cancer patients nationwide participated in the study, including 17 here at START. Researchers tested those patients' tumors for the presence of the protein, which tumor cells can use to switch off an immune system response to the cancer.

The result "is very compelling," said Roy Herbst, chief of medical oncology at Yale Cancer Center, which participated in the Merck trial. "This could tell us who should get this drug and who shouldn't."

All patients participating in the trial received Keytruda, and tumors shrank in 19 percent of the patients overall. Yet close to half of the patients with high levels of the protein experienced significant tumor shrinkage.

Only 17 percent of the patients with low levels of the protein saw shrinkage of their tumors, compared to 11 percent of patients who had hardly any of the protein.

"These results have the potential to substantively change the way that lung cancer is treated," said Edward Garon, a medical oncologist at the Jonsson Comprehensive Cancer Center of the University of California at Los Angeles, who is lead author of the lung cancer study.

The first 19 people to ever take Keytruda were patients who received the medication at START as part of a Phase I study in 2011 that was focused on the drug's safety and side effects. Those patients suffered from various forms of cancer - three of them had melanoma, Patnaik said.

A later study focused on Keytruda's effectiveness in treating melanoma specifically. That study, published in the New England Journal of Medicine in 2013, involved 23 patients from START and plus those from other cancer institutions.

"Drugs like this, which are breakthrough therapy drugs, are available here in San Antonio," Patnaik said Monday. "Patients have access to them. They're being developed by START, which is a global Phase I research program. And it really speaks to the quality of research that's happening here in town.

"It also reflects the fact that we are setting new milestones in terms of research in San Antonio ... We don't always necessarily get national recognition for the work that we do, but we're very much part of that landscape - having contributed to the success of a compound that is clearly changing both the (survival) of patients with horrible conditions for which really there are no effective therapies. And it's also making quality of life better."

Keytruda is among the first of a new generation of immune therapy drugs that aims to trigger the body's own immune system to attack and kill tumor cells. Both Keytruda and a similar product, Opdivo from Bristol-Myers, were approved for melanoma last year.

Express-News Staff Writer Peggy O'Hare and Bloomberg News contributed to this report.

 

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