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FDA approves Merck immune-stimulating drug for melanoma

i Sep 4th No Comments by

U.S. regulators on Thursday approved the first drug in a new class of cancer medicines that work by stimulating the immune system, a Merck drug developed for treating deadly skin cancer.

The Food and Drug Administration says it granted accelerated approval for the use of Merck & Co Inc’s immuno-oncology drug Keyrtruda, also know as pembrolizumab, as a treatment for patients with advance melanoma, who are no longer responding to other therapies.

The drug is the first in a promising new class of antibody-based drugs that work by taking a brake off the immune system so it can better recognize and attack cancer cells. The drug is designed to help the body’s own immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to evade disease-fighting cells.

“This is the latest in a string of major breakthroughs in melanoma treatment that will galvanize the field of melanoma research and cancer treatment,” Wendy Selig, Melanoma Research Alliance president and CEO, said in a statement.

“Pembrolizumab has demonstrated real potential to save the lives of late-stage melanoma patients who had little hope of survival just a few years ago,” Selig said.

Melanoma, the deadliest form of skin cancer, is diagnosed in around 76,000 Americans each year and around 10,000 will die from the disease annually, according to the National Cancer Institute.

The FDA said in a statement that clinical trials of Keytruda showed that it shrank tumors in around 24 percent of patients with advanced melanoma whose disease worsened after prior treatment.

Read the full article on FoxNews.com.

Is the cure for cancer inside you?

i Dec 16th No Comments by

Claudia Steinman saw her husband’s BlackBerry blinking in the dark. It had gone untouched for several days, in a bowl beside his keys, the last thing on anybody’s mind. But about an hour before sunrise, she got up to get a glass of water and, while padding toward the kitchen, found an e-mail time-stamped early that morning — “Sent: Monday, Oct. 3, 2011, 5:23 a.m. Subject: Nobel Prize. Message: Dear Dr. Steinman, I have good news for you. The Nobel Assembly has today decided to award you the Nobel Prize in Physiology or Medicine for 2011.” Before she finished reading, Claudia was hollering at her daughter to wake up. “Dad got the Nobel!” she cried. Alexis, still half-asleep, told her she was crazy. Her father had been dead for three days.

The Nobel Foundation doesn’t allow posthumous awards, so when news of Ralph Steinman’s death reached Stockholm a few hours later, a minor intrigue ensued over whether the committee would have to rescind the prize. It would not, in fact; but while newspapers stressed the medal mishap (“Nobel jury left red-faced by death of laureate”), they spent less time on the strange story behind the gaffe. That Steinman’s eligibility was even in question, that he’d been dead for just three days instead of, say, three years, was itself a minor miracle.

In the spring of 2007, Steinman, a 64-year-old senior physician and research immunologist at Rockefeller University in New York, had come home from a ski trip with a bad case of diarrhea, and a few days later he showed up for work with yellow eyes and yellow skin — symptoms of a cancerous mass the size of a kiwi that was growing on the head of his pancreas. Soon he learned that the disease had made its way into nearby lymph nodes. Among patients with his condition, 80 percent are dead within the first year; another 90 percent die the year after that. When he told his children about the tumor over Skype, he said, “Don’t Google it.”

But for a man who had spent his life in the laboratory, who brought copies of The New England Journal of Medicine on hiking trips to Vermont and always made sure that family vacations overlapped with scientific symposia, there was only one way to react to such an awful diagnosis — as a scientist. The outlook for pancreatic cancer is so poor, and the established treatments so useless, that any patient who has the disease might as well shoot the moon with new, untested therapies. For Steinman, the prognosis offered the opportunity to run one last experiment.

In the long struggle that was to come, Steinman would try anything and everything that might extend his life, but he placed his greatest hope in a field he helped create, one based on discoveries for which he would earn his Nobel Prize. He hoped to reprogram his immune cells to defeat his cancer — to concoct a set of treatments from his body’s own ingredients, which could take over from his chemotherapy and form a customized, dynamic treatment for his disease. These would be as far from off-the-shelf as medicines can get: vaccines designed for the tumor in his gut, made from the products of his plasma, that could only ever work for him.

Steinman would be the only patient in this makeshift trial, but the personalized approach for which he would serve as both visionary and guinea pig has implications for the rest of us. It is known as cancer immunotherapy, and its offshoots have just now begun to make their way into the clinic, and treatments have been approved for tumors of the skin and of the prostate. For his last experiment, conducted with no control group, Steinman would try to make his life into a useful anecdote — a test of how the treatments he assembled might be put to work. “Once he got diagnosed with cancer, he really started talking about changing the paradigm of cancer treatment,” his daughter Alexis says. “That’s all he knew how to do. He knew how to be a scientist.”

READ THE FULL ARTICLE AT NYTIMES.COM

NCI renews SPORE grant of more than $12 million for melanoma, skin cancer research at UPCI

i Nov 12th No Comments by

JohnKirkwoodThe University of Pittsburgh Cancer Institute (UPCI) Melanoma and Skin Cancer Program (MSCP) led by John Kirkwood, M.D., has received renewal of its skin cancer research through the National Cancer Institute’s competitive Specialized Program of Research Excellence (SPORE) program. The grant is for more than $12 million.

Since, Aug. 2012, Jessica Fera, founder and executive director of The Woiner Foundation, has served as a patient advocate for Dr. Kirkwood’s SPORE program, and was part of the team that helped to submit the grant for renewal.  The Woiner Foundation directly supports Dr. Kirkwood’s work through its fundraising initiatives.

The award is the fourth grant awarded to UPCI through the prestigious SPORE program, which requires cancer institutes to document strong collaboration between eminent scientists and clinicians as well as outstanding programs in translational research. The other three grants at UPCI are in head and neck, lung and ovarian cancers.
The SPORE grant for skin cancer will fund three new projects and the expansion of one prior project. These include:

  • Biomarkers of the proinflammatory response and elements of immune suppression: The goal of this project is to find biomarkers in melanoma patients at diagnosis or early in the disease that may predict the benefit of treatment with the drugs ipilimumab or interferon-α (IFNα) for each individual, as well as to assess the risk of melanoma recurrence and death. This effort continues earlier research that revealed biomarker patterns associated with pro-inflammatory immune responses and with immunosuppression in both tumor tissue and circulating blood.
  • Multiple antigen-engineered dendritic cell immunization and IFNα-2b boost for vaccine immunotherapy of metastatic melanoma: This project tests an improved dendritic cell vaccine targeting tumor antigens given in combination with IFNα-2b with the aim of boosting the immune response against the cancer.
  • Safety and efficacy of vemurafenib and high-dose IFNα-2b for advanced melanoma: This project will test whether vemurafenib, a drug that inhibits a signaling protein called BRAF, can enhance the therapeutic efficacy of IFNα-2b in patients with metastatic melanoma. In earlier work, the team found BRAF inhibitors make melanoma cells more sensitive to the effects of IFN-α, suppressing cell proliferation and encouraging apoptosis, or programmed cell death; increase T cell-mediated immune responses to melanoma cells; and prolong the survival of mice in a model of melanoma.
  • A microneedle vaccine program for immunotherapy of melanoma and cutaneous T cell lymphoma

Dr. Kirkwood’s melanoma research team first received SPORE funding five years ago and the grant’s five past projects have focused on immune approaches to treatment of melanoma and other skin cancers. The incidence of melanoma continues to rise dramatically. There has not been effective therapy to improve overall survival for the majority of patients with inoperable metastatic disease, although progress in the molecular therapy and immunotherapy of melanoma now has improved prospects for patients with melanoma considerably.

“We want to improve our understanding of the molecular and immunologic mechanisms underlying melanoma progression and to validate prognostic and predictive biomarkers that will lead to the personalized treatment of melanoma and other skin cancers,” Dr. Kirkwood said. “Our research is unique because we have integrated an approach that includes experts in melanoma from medical oncology, dermatology, surgery, immunology, biostatistics, bioinformatics, and biomarker discovery.”

Nancy E. Davidson, M.D., director of UPCI and its clinical partner, UPMC CancerCenter, called the SPORE grant a “perfect storm” in that it combines UPCI’s long-term scientific and clinical expertise in melanoma and immunology with the activities of the Department of Dermatology under the leadership of Louis Falo, M.D., Ph.D., and is tightly linked to national and international clinical trials activities in the cooperative groups.

“Multidisciplinary care is at the crux of modern cancer medicine and is critical for scientific discovery and translation,” Dr. Davidson said. “This SPORE grant is a great example of that.”

About 76,000 new cases of melanoma are diagnosed every year in the United States and about 9,400 people will die every year from the disease, according to the National Cancer Institute.

Dr. Kirkwood said the work being done through the SPORE grants is already making a difference. There have been several new therapies for melanoma approved since 2011, compared to just three agents approved in the 30 years prior.

About UPCI
As the only NCI-designated comprehensive cancer center in western Pennsylvania, UPCI is a recognized leader in providing innovative cancer prevention, detection, diagnosis, and treatment; bio-medical research; compassionate patient care and support; and community-based outreach services. UPCI, a partner with UPMC CancerCenter, investigators are world-renowned for their work in clinical and basic cancer research.

Source: UPMC.com

Predicting cancer’s next move

i Nov 11th No Comments by

Research led by Broad senior associate member Levi Garraway and published this week in Nature offers a new approach to studying drug resistance in cancer. The approach helped them identify which biological pathways could be enabling melanoma to circumvent available anti-cancer treatments. Targeting the output of these pathways for treatment could potentially hinder the course of this often-fatal disease.

The researchers initiated the study to address a vexing clinical problem: on the rare occasions that drug treatments are found that effectively inhibit tumor growth, that success is often short-lived. As resistance mechanisms emerge, the therapies cease being effective and the tumors return.

Such is the case in melanoma. Roughly 50% of these cancers have been traced to a mutation in BRAF, a gene responsible for directing cell growth. Only a few years ago, drugs were developed that disrupt parts of the biological pathway that leads the mutation to spur unchecked growth in skin cells. Patients who have received the treatment have seen their tumors disappear – only to return an average of nine months later. Garraway’s team, which includes researchers from the Broad Institute and Dana-Farber Cancer Institute, wanted to find out in a comprehensive fashion what mechanisms might be involved in the development of drug resistance in these cases.

Read the full article at MedicalXpress.com.

Immune drugs hold hope of “clinical cure” for deadly skin cancer

i Sep 28th No Comments by

A new generation of drugs designed to trigger the immune system to fight cancer is offering the prospect of a “clinical cure” for some melanoma skin cancer patients who until a few years ago were more likely to be facing a swift death.

Cancer specialists gathering for a European conference at the weekend said the so-called immunotherapy drugs, a class led by Bristol-Myers Squibb’s Yervoy, or ipilimumab, have transformed an area of oncology in which until recently doctors barely had time to get to know their patients.

Stephen Hodi, assistant professor of medicine at the Dana-Farber Cancer Institute in the United States, said he was cautious about using the term cure, but described recent advances as a “paradigm shift”.

At the least, he said, the success of this new generation of medicines means some melanoma patients would now be living with a chronic disease, rather than facing imminent death.

“This is a really amazing time … A few years ago we could never have imagined using the C-word, cure, in melanoma,” he said. “But we are headed that way.”

“Ipilimumab opened a door, and now the field is moving extremely fast,” he told Reuters at the European Cancer Congress (ECC) in Amsterdam.

Read the full article from Reuters.com.

Related article: ECC 2013: Longest follow-up of largest number of melanoma patients treated with ipilimumab shows some survive up to ten years

FDA approves Abraxane for advanced pancreatic cancer

i Sep 6th No Comments by

The U.S. Food and Drug Administration today expanded the approved uses of Abraxane to treat patients with advanced (metastatic) pancreatic cancer.

Pancreatic cancer is the fourth leading cause of cancer death in the United States. An estimated 45,220 patients will be diagnosed and 38,460 will die from the disease in 2013, according to the National Cancer Institute. Surgery is the only option to permanently remove or cure pancreatic cancer, but it usually is too late for surgery by the time the cancer is diagnosed.

“Patients with pancreatic cancer are often diagnosed after the cancer has advanced and cannot be surgically removed,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “In these situations, and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life.”

Abraxane is a chemotherapy drug that can slow the growth of certain tumors. Abraxane is intended to be used with gemcitabine, another chemotherapy drug, in patients with pancreatic cancer that has spread to other parts of the body.

The FDA reviewed the new use for Abraxane under the agency’s priority review program, which provides for an expedited review of drugs. Abraxane was also granted orphan product designation for pancreatic cancer because it is intended to treat a rare disease or condition.

The FDA approval of Abraxane is the first new treatment to be approved for adenocarcinoma pancreatic cancer in nearly eight years.

Pancreatic Cancer Action Network Press Release

FDA Press Release

Melanoma drugs extend life for some patients

i Jun 3rd No Comments by

Researchers will present studies of three promising melanoma therapies today, part of a wave of new treatments for the most aggressive forms of the disease.

None of the new therapies are cures for melanoma.

But a fraction of patients see rapid improvement in their condition, with dramatic shrinkage of their tumors, says F. Stephen Hodi, director of the melanoma center at Boston’s Dana-Farber Cancer Institute.

Hodi, who studied a drug called ipilimumab, will discuss his findings in Chicago today at the annual meeting of the American Society of Clinical Oncology.

The Food and Drug Administration approved ipilumumab, sold under the brand name Yervoy, in 2011. Yervoy, the first new drug for melanoma to be approved in more than a decade, helped patients live a median of 10 months, four months longer than those who were given an alternative experimental therapy.

Read the full story at USAToday.com.

Drug combos are the future of melanoma treatment

i Jun 3rd No Comments by

Giving experimental agents known as immune checkpoint blockers together or sequentially leads to improved outcomes in metastatic melanoma, according to the results of 2 studies published in the New England Journal of Medicine (NEJM) today.

The studies are both phase 1 trials, and therefore the outcomes are limited in their authority. However, the results are encouraging, especially the findings that the drug combinations did not result in a higher rate and severity of adverse events compared with the individual drugs alone, observes James Riley, PhD, of the Abramson Cancer Research Center at the University of Pennsylvania in Philadelphia. He wrote an editorial that accompanies the new studies.

The studies are also being presented here today at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO®).

“The future is all about combination therapies,” said Jedd Wolchok, MD, PhD, a melanoma expert at the Memorial Sloan-Kettering Cancer Center in New York City. He spoke with Medscape Medical News in an interview. Dr. Wolchok said that melanoma will now go the way of other diseases such as tuberculosis and HIV, which have been increasingly successfully treated with the adoption of multiple drug regimens.

Read the full article at MedScape.com.

FDA proposes tougher regulations on tanning beds

i May 7th No Comments by

Tanning beds could soon come with a warning label, alerting users to the risk of skin cancer and noting that the devices shouldn’t be used by people under 18.

Those changes could come through a new proposal from the Food and Drug Administration, which today announced plans to change the way that the sunlamps used in tanning beds are regulated.

Today, these tanning lamps, which emit ultraviolet radiation, are regulated as “low-risk,” class 1 devices, in the same category as tongue depressors and Band-Aids. These products aren’t required to be reviewed before going on the market, said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

Under the proposed change, tanning lamps would be considered class 2 devices, in the same category as CT scanners, which also expose people to radiation, Shuren said.

If the proposed order is finalized, “There will be requirements that products have to meet in order to go on the market,” Shuren said. Tanning machines also will warn customers not to use them if they have skin cancer or open skin lesions, or if they have a family history of skin cancer.

Read the full article on USAToday.com.

New York Times: Our feel-good war on breast cancer

i Apr 26th No Comments by

This article by Peggy Orenstein is a must-read for all of us working to raise funds and awareness for any type of cancer, not just breast cancer. You would hope that your favorite non-profit has the best intentions, but where the money goes is so important. The Woiner Foundation is dedicated to supporting research initiatives in the Pittsburgh area and we’re working directly with the doctors and researchers to make sure it’s making the biggest impact.

Here’s an excerpt:

I used to believe that a mammogram saved my life. I even wrote that in the pages of this magazine. It was 1996, and I had just turned 35 when my doctor sent me for an initial screening — a relatively common practice at the time — that would serve as a base line when I began annual mammograms at 40. I had no family history of breast cancer, no particular risk factors for the disease.

So when the radiologist found an odd, bicycle-spoke-like pattern on the film — not even a lump — and sent me for a biopsy, I wasn’t worried. After all, who got breast cancer at 35?

It turns out I did. Recalling the fear, confusion, anger and grief of that time is still painful. My only solace was that the system worked precisely as it should: the mammogram caught my tumor early, and I was treated with a lumpectomy and six weeks of radiation; I was going to survive.

By coincidence, just a week after my diagnosis, a panel convened by the National Institutes of Health made headlines when it declined to recommend universal screening for women in their 40s; evidence simply didn’t show it significantly decreased breast-cancer deaths in that age group. What’s more, because of their denser breast tissue, younger women were subject to disproportionate false positives — leading to unnecessary biopsies and worry — as well as false negatives, in which cancer was missed entirely.

Those conclusions hit me like a sucker punch. “I am the person whose life is officially not worth saving,” I wrote angrily. When the American Cancer Society as well as the newer Susan G. Komen foundation rejected the panel’s findings, saying mammography was still the best tool to decrease breast-cancer mortality, friends across the country called to congratulate me as if I’d scored a personal victory. I considered myself a loud-and-proud example of the benefits of early detection.

Sixteen years later, my thinking has changed. As study after study revealed the limits of screening — and the dangers of overtreatment — a thought niggled at my consciousness. How much had my mammogram really mattered? Would the outcome have been the same had I bumped into the cancer on my own years later? It’s hard to argue with a good result. After all, I am alive and grateful to be here. But I’ve watched friends whose breast cancers were detected “early” die anyway. I’ve sweated out what blessedly turned out to be false alarms with many others.

Read the full article at nytimes.com.