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NICE Proposes Ipilimumab as a First Treatment for Advanced Skin Cancer

NICE Proposes Ipilimumab as a First Treatment for Advanced Skin Cancer | Melanoma Dispatch | Scoop.it

"People with advanced skin cancer should be able to receive ipilimumab as a first treatment, the National Institute for Health and Care Excellence (NICE) proposes.


"In final draft guidance, NICE recommends that the drug ipilimumab (also called Yervoy and manufactured by Bristol-Myers Squibb Pharmaceuticals Limited) is made available on the NHS as a first-line treatment for patients with advanced malignant melanoma which is either unresectable (when the full tumour cannot be removed) or metastatic (the cancer has spread to other parts of the body).


"Sir Andrew Dillon, NICE chief executive, said: 'We already recommend ipilimumab as a second-line treatment and so we are pleased to be able to propose extending that recommendation to first line treatment too.' "


Editor's note: The UK's public healthcare system is required to provide funding for treatments recommended by NICE. To learn more about targeted melanoma drugs like ipilimumab, read The Basics.

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NICE  |  Jun 12, 2014

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ASCO: Targeting PD-1 Works in Advanced Melanoma

ASCO: Targeting PD-1 Works in Advanced Melanoma | Melanoma Dispatch | Scoop.it

"Two studies indicate that using investigative immunotherapy drugs improves survival and response in patients with metastatic melanoma, researchers said here.


"In one study, the agent pembrolizumab (MK-3475) which targets the programmed death (PD-1) pathway produced a 1-year 69% survival rate, said Antoni Ribas, MD, PhD, professor of medicine at the UCLA Jonsson Comprehensive Cancer Center in Los Angeles.


"In a second study reported in a press conference at the annual meeting of the American Society of Clinical Oncology, Mario Sznol, MD, professor of medicine at the Yale Cancer Center, demonstrated that a combination of the investigative PD-1 inhibitor nivolumab in combination with another targeted agent ipilimumab (Yervoy) produced a 1-year survival rate of 85% and 2-year survival rate of 79% for advanced melanoma patients."


Editor's note: Immunotherapy drugs boost a patient's own immune system to fight cancer. Promising research into new immunotherapy drugs for melanoma was recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Two treatments that received special attention were MK-3475 (aka pembrolizumab) and a combination of the drugs ipilimumab (Yervoy) and nivolumab.

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MedPage Today  |  Jun 5, 2014

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Incyte : Announces Preliminary Results of a Phase I/II Study of Combination Immunotherapy in Patients with Melanoma

"Incyte Corporation (Nasdaq: INCY) today announced that preliminary results from an ongoing Phase I/II study of INCB24360, its oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, combined with ipilimumab in patients with unresectable or metastatic melanoma were presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 30 to June 3, 2014, in Chicago. The poster reported initial findings showing that the combination was generally well tolerated and produced evidence of clinical response."

Editor's note: This article discusses a new treatment for melanoma that combines a drug called INCB24360 with the drug ipilimumab (Yervoy). Both drugs are immunotherapies, meaning they boost a patient's own immune system to fight cancer. A clinical trial testing the combo in volunteer patients found promising preliminary results.
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4-traders  |  Jun 2, 2014

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Business: Washington Post Business Page, Business News

"Kim Sherman was in bad shape a year ago after a lemon-sized melanoma tumor in her pelvis stopped responding to standard targeted therapy. By late June 2013, the pain from the mass pressing on her hamstring became so bad she could hardly sleep, walk, or even sit down.

"Then she joined a trial on an experimental drug from Bristol-Myers Squibb Co. designed to boost the immune system against her tumor when used in combination with the company’s existing immune enhancing drug Yervoy. Within three weeks the pain started to subside, and within three months later the tumor disappeared. Her doctor at Yale Cancer Center in New Haven may stop therapy entirely in a few weeks, she said."

Editor's note: This article discusses immunotherapy treatments, which boost a patient's own immune system to fight cancer. Learn more about immunotherapy for melanoma in The Basics.

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The Washington Post  |  Jun 2, 2014

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Immunotherapy Shows Promise Against Melanoma

Immunotherapy Shows Promise Against Melanoma | Melanoma Dispatch | Scoop.it

"By unleashing the immune system to attack skin cancer, researchers have made important strides against melanoma, according to the results of three clinical trials released Monday.


"The first study presented at the American Society of Clinical Oncology annual meeting showed patients given a drug called Yervoy (ipilimumab), made by Bristol Myers-Squibb, saw a 25 percent reduced risk of the cancer coming back when compared to a placebo."


Editor's note: Immunotherapy treatments, which boost a patient's own immune system to fight cancer, were a big topic this past weekend at the American Society of Clinical Oncology (ASCO) Annual Meeting. This article provides an overview of some new findings in immunotherapy for melanoma.

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Medical Xpress  |  Jun 2, 2014

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Long-Term Results Encouraging for Combination Immunotherapy for Advanced Melanoma

Long-Term Results Encouraging for Combination Immunotherapy for Advanced Melanoma | Melanoma Dispatch | Scoop.it

"The first long-term follow-up results from a phase 1b immunotherapy trial combining drugs for advanced melanoma patients has shown encouraging results—long-lasting with high survival rates—researchers report. First author Mario Sznol, M.D., professor of medical oncology at Yale Cancer Center, is presenting the updated data at the 2014 annual conference of the American Society of Clinical Oncology (ASCO) in Chicago.


"Sznol, clinical research leader of the melanoma research program at Yale Cancer Center, was the senior author on the original study of combination immunotherapy that was first published in the New England Journal of Medicine and presented at ASCO in 2013. Jedd Wolchok, M.D., of Memorial Sloan Kettering Cancer Center was first author of the earlier study, and senior author of this updated research."


Editor's note: Immunotherapy treatments boost a patient's own immune system to fight cancer. This story describes a promising treatment that combines two immunotherapy drugs: nivolumab and ipilimumab (Yervoy).

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Medical Xpress  |  Jun 2, 2014

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T-cell Changes: Why Only Some Respond to Ipilimumab

"The immunotherapy ipilimumab (Yervoy, Bristol-Myers Squibb Company) works amazingly well in some patients, hardly at all in others. A groundbreaking study that used deep sequencing techniques offers some clues as to why.


"Ipilimumab, which is marketed for melanoma but is being explored in several other cancer types, including prostate cancer, acts as a checkpoint blocker by inhibiting cytotoxic T lymphocyte– associated antigen–4 (CTLA-4).


"Immune repertoire sequencing has confirmed that blocking CTLA-4 increased turnover and diversity of the T-cell repertoire in some patients with advanced prostate cancer or metastatic melanoma, but also showed that patients who survived longest maintained clones of high-frequency T-cells they had developed before starting treatment."


Editor's note: Ipilimumab is a drug that boosts a patient's own immune system to fight cancer. It works by activating immune system cells called T cells, some subtypes of which may then attack tumors. Ipilimumab works very well for some patients, but not for others. This study found that patients who had certain tumor-fighting T cell subtypes already present before ipilimumab treatment were more likely to respond well and survive longer, possibly because these cells were readily available to fight cancer upon activation. The study also found that ipilimumab may prompt the immune system to "re-shuffle" the body's T cell subtypes, allowing patients with only a small amount of tumor-fighting T cells to generate more. (This may explain why some patients take longer to respond to ipilimumab than others; their immune systems need more time to build up the right T cells.) Based on the results, doctors may be able to monitor a patient's T cell subtypes ("immune repertoire sequencing") to determine whether ipilimumab will work, or to keep tabs on the effectiveness of ongoing ipilimumab treatment.

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Medscape  |  May 28, 2014

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Medscape  |  May 28, 2014

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Ipilimumab May Become Standard of Care for Adjuvant Melanoma Therapy

Ipilimumab May Become Standard of Care for Adjuvant Melanoma Therapy | Melanoma Dispatch | Scoop.it

"Two phase 3 trials currently underway are expected to help answer the provocative question of whether ipilimumab will replace interferon as the standard of care for adjuvant therapy in melanoma, according to a presenter at the HemOnc Today Melanoma and Cutaneous Malignancies meeting.


“ 'We really have a new path forward and a new beginning,' Lynn M. Schuchter, MD, chief of the division of hematology/oncology and C. Willard professor of medicine at Abramson Cancer Center at the University of Pennsylvania, said during a presentation. 'I’m hopeful we will advance this therapy further by refining proper patient selection, matching the right biomarkers and modifying toxicities.' "


Editor's note: Clinical trials are research studies done with volunteer patients. Learn more about the risks and advantages of trials for patients here. The clinical trials described in this story are testing the ability of the drug ipilimumab to prevent recurrence in patients who have already been treated for stage III and stage IV melanoma. Interferon is currently the standard of care for so-called 'adjuvant therapy' to prevent recurrence, but ipilimumab may soon replace it.

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Healio  |  Apr 11, 2014

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Genetic Testing Beneficial in Melanoma Treatment

Genetic Testing Beneficial in Melanoma Treatment | Melanoma Dispatch | Scoop.it

"Genetic screening of cancer can help doctors customize treatments so that patients with melanoma have the best chance of beating it, according to the results of a clinical trial by researchers at the University of Pittsburgh Cancer Institute (UPCI), a partner with UPMC CancerCenter.


"The trial, funded by the National Institutes of Health (NIH), will be presented Monday at the American Association for Cancer Research (AACR) Annual Meeting 2014. It showed that the cancer immune therapy drug ipilimumab appears most likely to prevent recurrence in patients whose cancer shows high expression of immune-related genes."


Editor's note: To learn more about genetic screening and personalized approaches to melanoma treatment, read our Melanoma Basics.

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Medical Xpress  |  Apr 4, 2014

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Immunotherapy, BRAF Inhibitor Sequence Affected Outcomes in Metastatic Melanoma

Immunotherapy, BRAF Inhibitor Sequence Affected Outcomes in Metastatic Melanoma | Melanoma Dispatch | Scoop.it

"Prior treatment with immunotherapy did not limit response to BRAF inhibitors among patients with metastatic melanoma, according to results of a retrospective study.


"However, patients who underwent initial treatment with BRAF inhibitors and subsequently received immunotherapy with ipilimumab (Yervoy, Bristol-Myers Squibb) demonstrated poorer outcomes, results showed.


"Patients with BRAF-positive metastatic melanoma have several treatment options, including BRAF inhibitors vemurafenib (Zelboraf, Hoffmann-La Roche) and dabrafenib  (Taflinar, GlaxoSmithKline), the MEK inhibitor trametinib (Mekinist, GlaxoSmithKline), and the immunotherapy agents ipilimumab and interleukin-2. Yet, there are limited data with regard to optimal sequencing, according to researchers."

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Healio  |  Mar 14, 2014

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Prior treatment with BRAF inhibitors reduced subsequent response to immunotherapy. Prior treatment with ipilimumab had no effect on response to BRAF inhibitors.

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Marker May Predict Response to Ipilimumab in Advanced Melanoma

Marker May Predict Response to Ipilimumab in Advanced Melanoma | Melanoma Dispatch | Scoop.it

"Among patients with advanced melanoma, presence of higher levels of the protein vascular endothelial growth factor (VEGF) in blood was associated with poor response to treatment with the immunotherapy ipilimumab, according to a study published inCancer Immunology Research, a journal of the American Association for Cancer Research.


"The study suggests combining immunotherapy with VEGF inhibitors, also known as angiogenesis inhibitors, may be a potential option for these patients."

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Medical Xpress  |  Feb 4, 2014

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Experimental Melanoma Immunotherapy Continues to Hold Promise

In keeping with results from other studies, new research supports treating melanomas with the experimental immunotherapy nivolumab. This drug blocks a protein—called PD-1—that lets tumor cells evade the immune system. In a phase I clinical trial, nivolumab shrank tumors in 25% of 90 people with melanomas that had spread. Some of these tumors had not responded to the U.S. Food and Drug Administration (FDA)-approved immunotherapy ipilimumab. In addition, some tumors that did not respond to nivolumab did respond to ipilimumab. Taken together, these findings suggest that melanomas could be treated with these two drugs either in combination or sequentially.

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Journal of Clinical Oncology │Oct 20, 2013

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Ipilimumab Gives Some Melanoma Patients 10 More Years

People with melanomas that have spread can live as long as a decade when treated with the U.S Food and Drug Administration (FDA)-approved immunotherapy drug Yervoy (ipilimumab), according to a report at a cancer conference in Amsterdam, Netherlands. Ipilimumab activates the immune system's attack on tumor cells, which is normally inhibited. The researchers evaluated 12 ipilimumab trials totaling more than 1,800 people with melanoma, making this the largest follow-up skin cancer study ever. They found that 22% survived at 3 years and 17% survived at 7 years and were still alive at up to 10 years. Now, Yervoy manufacturer Bristol-Myers is testing the combination of ipilimumab with an experimental immunotherapy drug called nivolumab, which blocks a protein (PD-1) that lets tumor cells evade the immune system. So far, the combo treatment outperforms ipilimumab alone in an early trial, extending life to a year in 82% of 53 people with melanoma.

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Bloomberg│Sep 27, 2013

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Adjuvant Ipilimumab Improved RFS in High-Risk, Stage III Melanoma

Adjuvant Ipilimumab Improved RFS in High-Risk, Stage III Melanoma | Melanoma Dispatch | Scoop.it

"Adjuvant ipilimumab significantly improved RFS compared with placebo among patients with resected stage III melanoma who were at high risk for recurrence, according to the final analysis of a phase 3 study presented at the ASCO Annual Meeting.


“ 'Although there are approved adjuvant therapies, they are still to be improved, and this is clearly an unmet need,' researcher Alexander Eggermont, MD, PhD, director general of the Gustave Roussy Cancer Campus Grand Paris in France, said during a press conference. 'Ipilimumab is the first drug approved for metastatic melanoma, based on a proven impact on OS. This is the first trial ever with a drug that had an improvement in OS in metastatic melanoma.' "


Editor's note: Patients with advanced melanoma who have their tumors removed by surgery ("resected") can be at high risk for recurrence of their cancer. In a clinical trial with volunteer patients, researchers are testing an "adjuvant" treatment meant to prevent recurrence. All patients had resected stage III melanoma. It was found that patients who took the drug ipilimumab (Yervoy) after resection had a significantly greater amount of time pass before recurrence than patients who took a placebo. Further follow-up of the patients will reveal effects on overall survival.

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Healio  |  Jun 10, 2014

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Ipilimumab Nivolumab Combination Demonstrated Encouraging Activity in Advanced Melanoma

Ipilimumab Nivolumab Combination Demonstrated Encouraging Activity in Advanced Melanoma | Melanoma Dispatch | Scoop.it

"The combination of the immunotherapy agents ipilimumab and nivolumab induced extensive and durable tumor shrinkage in patients with advanced melanoma, according to long-term study results presented at the ASCO Annual Meeting.

“ 'These are two distinct immune checkpoint inhibitors, so it makes sense to combine them together,' researcher Mario Sznol, MD, a professor of medical oncology at Yale School of Medicine, said during a press conference. 'They both produce very significant clinical activity as monotherapy in advanced melanoma.' ”

Editor's note: Immunotherapy treatments boost a patient's own immune system to fight cancer. A new immunotherapy treatment combines two individual immunotherapy drugs: ipilimumab (Yervoy) and nivolumab. In a clinical trial to test the combo in volunteer patients with advanced melanoma, the treatment was found to provide promising survival results. Further studies are needed to see just how well the treatment might work.

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Healio  |  Jun 4, 2012

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Amgen Presents New Data On Talimogene Laherparepvec As Single Agent And Combination Therapy In Metastatic Melanoma At ASCO

Amgen Presents New Data On Talimogene Laherparepvec As Single Agent And Combination Therapy In Metastatic Melanoma At ASCO | Melanoma Dispatch | Scoop.it

"Amgen today announced new data from two key clinical trials that support the potential of talimogene laherparepvec, a novel, investigational oncolytic immunotherapy, as both a single agent and as part of a combination regimen in patients with metastatic melanoma. The findings were presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago."


Editor's note: This article describes promising results for a melanoma treatment called talimogene laherparepvec (T-VEC), an immunotherapy that boosts a patient's own immune system to fight cancer. Previous testing of the drug has found mixed results.

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MarketWatch  |  Jun 2, 2014

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MK3475 Induced High Rates of Durable Responses in Advanced Melanoma

MK3475 Induced High Rates of Durable Responses in Advanced Melanoma | Melanoma Dispatch | Scoop.it

"A majority of patients with advanced melanoma who had and had not received previous ipilimumab demonstrated durable responses with the PD-1 targeted antibody MK-3475, according to study results presented at the ASCO Annual Meeting.


“ 'This is the largest phase 1 clinical trial ever conducted in this disease, and together with a lung cancer cohort, this is the largest phase 1 trial ever done in oncology,' study investigator Antoni Ribas, MD, PhD, professor of medicine at the David Geffen School of Medicine at the University of California in Los Angeles, said during a press conference. 'These are early data, but they tell us we are on to something really important.' ”


Editor's note: The cancer drug MK-3475 is an immunotherapy, meaning that it boosts a patient's own immune system to fight cancer. This story describes a clinical trial that tested MK-3475 on volunteer patients with advanced melanoma, and found good results for a majority of the patients. Some of the patients had previously been treated with the drug ipilimumab (Yervoy) and some had not; both kinds of patients benefited from MK-3475 in the trial.

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Healio  |  Jun 3, 2014

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New System for Treating Cancer Seen as Hopeful

New System for Treating Cancer Seen as Hopeful | Melanoma Dispatch | Scoop.it

"Drugs that unleash the body’s immune system to combat tumors could allow patients with advanced melanoma to live far longer than ever before, researchers gathered at the nation’s largest cancer conference say.


“ 'It’s a completely different world for patients with metastatic melanoma, to talk about the majority of patients being alive for years rather than weeks or months,' said Dr. Jedd D. Wolchok, a melanoma specialist at the Memorial Sloan-Kettering Cancer Center, interviewed at the annual meeting of the American Society of Clinical Oncology here."


Editor's note: This is a good exploration of immunotherapy treatments for melanoma; immunotherapy for lung cancer is also discussed.

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The New York Times  |  Jun 2, 2014

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The New York Times  |  Jun 2, 2014

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New Therapies Harness Power of the Immune System Against Cancer

New Therapies Harness Power of the Immune System Against Cancer | Melanoma Dispatch | Scoop.it

"New research on innovative immunotherapies for advanced or high-risk melanoma and cervical cancer were presented today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO). These treatments – used alone or in combination – fight cancer by activating and amplifying the body's immune response to the disease.


"The new studies find high activity with investigative drugs for advanced melanoma, and show for the first time that ipilimumab, a treatment already approved for advanced melanoma, can substantially decrease the risk of melanoma recurrence in certain patients with earlier-stage disease. In addition, another small trial reports that a one-time, personalized immunotherapy treatment induces complete and long-lasting remissions in a small number of women with advanced cervical cancer – a disease with little to no effective treatment options."


Editor's note: Immunotherapies are treatments that boost a patient's own immune system to fight cancer. Learn more.

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Medical Xpress  |  Jun 2, 2014

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FDA Grants Merck’s Anti-PD1 Antibody Priority Review

FDA Grants Merck’s Anti-PD1 Antibody Priority Review | Melanoma Dispatch | Scoop.it

"The FDA has granted Merck’s anti-PD1 antibody MK-3475 a priority review designation for the treatment of unresectable or metastatic melanoma in patients who have previously been treated with ipilimumab. Priority review status is reserved for drugs considered to offer a significant improvement in the safety or efficacy of the treatment of a serious condition. It will shorten the drug’s FDA review period from 10 months to 6 months."


Editor's note: MK-3475 is an immunotherapy drug that works by boosting a patient's own immune system to fight cancer. Once it is approved by the FDA for unresectable or metastatic melanoma, doctors in the U.S. will be able to prescribe it to their patients outside of the clinical trial system.

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Cancer Network  |  May 21, 2014

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Cancer Network  |  May 21, 2014

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Cancer Network  |  May 21, 2014

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Brain Metastases in Melanoma Require Multidisciplinary Approach

Brain Metastases in Melanoma Require Multidisciplinary Approach | Melanoma Dispatch | Scoop.it

Brain metastases are responsible for the majority of mortality and morbidity among patients with melanoma, and a multidisciplinary approach is necessary to effectively manage this complication, according to a presenter at the HemOnc Today Melanoma and Cutaneous Malignancies meeting.


“ 'This subject has not been well studied. This is the question that people didn’t want to address, but now people are taking on this task,' Geoffrey T. Gibney, MD, a medical oncologist in the department of cutaneous oncology at Moffitt Cancer Center, said during a presentation."


Editor's note: This article is a good summary of brain metastasis in melanoma.

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Healio  |  Apr 12, 2014

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Ipilimumab in Advanced Melanoma: Added Benefit for Non-Pretreated Patients Not Proven

Ipilimumab in Advanced Melanoma: Added Benefit for Non-Pretreated Patients Not Proven | Melanoma Dispatch | Scoop.it

"The German Institute for Quality and Efficiency in Health Care (IQWiG) already assessed the added benefit of ipilimumab in advanced melanoma in 2012. A considerable added benefit was found for patients who had already received previous treatment. In the new dossier compiled by the drug manufacturer, the drug was now compared with the appropriate comparator therapy dacarbazine specified by the Federal Joint Committee (G-BA) also for non-pretreated patients."


Editor's Note: This story is a little confusing, so here is a summary to clarify: It was already known that ipilimumab can be beneficial for people who have received previous treatment for melanoma. A new study aimed to find out if ipilimumab also improves survival for patients who have not received prior treatment. However, for a variety of reasons, the study did not show that ipilimumab performs any better than dacarbazine in patients who have not received prior treatment.

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Medical Xpress  |  Mar 18, 2014

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Experimental Drug Helps Body Fight Advanced Melanoma

Experimental Drug Helps Body Fight Advanced Melanoma | Melanoma Dispatch | Scoop.it

"An experimental drug that harnesses the power of the body's immune system to fight cancer has helped some patients with advanced melanoma keep their disease in check for several years, a new study indicates.


"Researchers think the drug, which is called nivolumab, may help reset the immune systemso that as a tumor adds new cells, the immune system is able to clear them away."


Editor's Note: The Medical Xpress article contains a misleading statement about Yervoy (ipilimumab). The article says, "up to 49 percent of patients were still alive after one year and up to 33 percent of patients were still alive two years after taking [Yervoy]." In fact, only about 10-20% of all patients who take Yervoy experience tumor shrinkage, and 49% of those are still alive after 1 year. The response rates to nivolumab are more promising.

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Medical Xpress  |  Mar 3, 2014

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New Trial Combines Two Immunotherapies Against Melanoma (Yervoy & Prophage)

New Trial Combines Two Immunotherapies Against Melanoma (Yervoy & Prophage) | Melanoma Dispatch | Scoop.it

Will the FDA-approved immune system booster Yervoy (ipilimumab) work better when combined with an experimental melanoma vaccine? Researchers are about to find out ─ the combination will be tested in a phase II clinical trial of up to 25 people. Ipilimumab doesn’t work on its own in about 70% of people with melanomas. The vaccine, called Prophage, could sharpen immune system attacks because it’s made from people’s own tumors.

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Agenus  |  Jan 14, 2014

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Immunotherapy Promises Breakthroughs in Cancer Treatment

Immunotherapy Promises Breakthroughs in Cancer Treatment | Melanoma Dispatch | Scoop.it

Researchers have begun to identify the mechanisms that tumors use to protect themselves from the body’s immune system. Disrupting these mechanisms frees the immune system to attack the cancer, offering the hope of effective therapies for otherwise hard-to-treat cancers. Among the first such treatments is ipilimumab (Yervoy), which was approved for treatment of melanoma in 2011. Additional immunotherapy drugs are currently under investigation for lung cancer treatment. Overall, these drugs produce modest increases in average survival. However, some patients respond dramatically: 20% of melanoma patients treated with Yervoy in a clinical trial are still alive up to 10 years later. In others, immunotherapy can cause the immune system to attack healthy cells also, leading to dangerous or even fatal reactions. Further research aims to uncover the reasons behind these different responses.

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New York Times | Oct 14, 2013

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New York Times | Oct 14, 2013