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Japan Approves World's First PD-1 Drug, Nivolumab

Japan Approves World's First PD-1 Drug, Nivolumab | Melanoma Dispatch | Scoop.it

"Ono Pharmaceutical Co has become the first company in the world to get an approval for a PD-1 checkpoint inhibitor, as regulators in Japan gave the green light to nivolumab, developed with Bristol-Myers Squibb, as a treatment for melanoma.

"The drug will be marketed as Opdivo for unresectable melanoma although Ono noted that because of the very limited number of patients treated with nivolumab in Japanese clinical trials, the firm is required to perform a 'post-marketing use-results survey covering all cases until data on a certain minimum number of patients have been accumulated'."


Editor's note: The drug nivolumab is an immunotherapy, meaning that it boosts a patient's own immune system to fight cancer. Nivolumab is a specific kind of immunotherapy drug known as a "PD-1 checkpoint inhibitor," since it works by releasing a protein "brake" on the immune system called PD-1. Researchers testing the drug in volunteer patients have found promising results, and Japan has now given the world's first approval to nivolumab, permitting doctors across the country to prescribe it to people with unresectable melanoma.

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PharmaTimes  |  Jul 7, 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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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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Old Cancer Drug Gets Fresh Look

Old Cancer Drug Gets Fresh Look | Melanoma Dispatch | Scoop.it

"When Dave deBronkart was diagnosed with advanced kidney cancer in 2007, he learned about a treatment called high-dose interleukin-2 (IL-2) that fires up the body’s immune system to fight the disease. The response rate was not great — tumours shrank in only about 15% of patients. And as many as 4% of people died from the treatment. But some of those who responded survived for years or even decades."


Editor's note: IL-2 is an immunotherapy drug, meaning that it boosts a patient's own immune system to fight cancer. It and other new immunotherapies are showing promise for patients across many different cancer types.

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Nature  |  May 27, 2014

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Nature  |  May 27, 2014

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Nature  |  May 27, 2014

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Future of Cancer Treatments

Future of Cancer Treatments | Melanoma Dispatch | Scoop.it

"The news spurred hundreds of phone calls and emails to Comprehensive Cancer Centers of Nevada from across the country: Two Stage 4 cancer patients at the Las Vegas center, after participating in the first human trial of an antibody drug with the unwieldy code name of MPDL 3280A, were now cancer-free.


"Rosemary Rathbun, 78, had been so far gone with throat cancer that doctors told her to enroll in hospice. Lorrine Rodgers, 56, had been told there were no other treatments for her spreading breast cancer.


"That their cancer disappeared, the women said in January, was a miracle."


Editor's note: This story is a great overview of an increasingly promising type of cancer treatment called immunotherapy. Immunotherapy treatments boost a patient's own immune system to fight cancer.

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Las Vegas Review-Journal  |  Apr 26, 2014

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Las Vegas Review-Journal  |  Apr 26, 2014

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Killing Cancer through the Immune System

Killing Cancer through the Immune System | Melanoma Dispatch | Scoop.it

"The immune system has this blind spot by design – an immune system that has an ability to attack itself leads to autoimmune diseases, so as protection, it screens out its own tissue.


"For decades, scientists assumed that cancer was beyond the reach of the body's natural defenses. But after decades of skepticism that the immune system could be trained to root out and eliminate these malignant cells, a new generation of drugs is proving otherwise.


"The treatment consists of infusing antibodies that enhance the immune system to recognize cancer cells and attack it. What's more, since the immune system has a built-in memory, it continues to go after cancer cells, so the response can be longer lasting and more complete.


"The trick is that this treatment doesn't work for everybody, and researchers don't yet understand why. But when it does work, the results have been particularly impressive."

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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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PD-1 Blocker Shrinks Melanomas in Early Trial

PD-1 Blocker Shrinks Melanomas in Early Trial | Melanoma Dispatch | Scoop.it

Results of an ongoing phase I clinical trial reinforce the promise of an experimental immunotherapy drug against melanoma. The drug, lambrolizumab, blocks a protein called PD-1, which lets cancer cells evade the immune system. In the new study, researchers gave lambrolizumab to 135 people with melanomas that had spread. Tumors shrank in more than half of those who got the highest dose of lambrolizumab (10 mg/kg every 2 wk), and disappeared completely in 12 people. Moreover, tumors still had not grown again more than a year later. Side effects were generally mild. This trial is currently accepting new participants.

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The New England Journal of Medicine│Jul 11, 2013

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Experimental PD-1 Blocker May Work Across Cancer Types

Experimental PD-1 Blocker May Work Across Cancer Types | Melanoma Dispatch | Scoop.it

Results of a phase I clinical trial suggest that a new immunotherapy drug called MPDL3280A could control a wide range of cancers. Manufactured by Roche Genentech, MPDL3280A is one of several promising but experimental drugs that block PD-1, a cell surface protein that disguises tumor cells from our immune systems. The study included 140 people with different kinds of tumors (melanoma as well as colorectal, gastric, kidney, and non-small cell lung cancers) that had resisted other treatments. Tumors shrank in 21% of those treated with MPDL3280A, particularly people with melanoma or lung cancer. These findings were presented at the 2013 meeting of the American Society of Clinical Oncology. While still in the very early stages of research, targeting tumors with our own immune systems has great potential to work across many different cancer types and to keep them in check longer than current treatments, say researchers, giving new hope to people with cancer.

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Science Daily│Jun 3, 2013

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Science Daily│Jun 3, 2013

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Fast-Tracked Immunotherapy Drug Still Promising for Melanoma

Encouraging results are in from the first clinical trial of lambrolizumab, an experimental immunotherapy drug that was granted a speedy review by the U.S. Food and Drug Administration in April. Formerly known as MK-3475, lambrolizumab blocks a protein (PD-1) that lets tumor cells evade the immune system. The researchers treated 135 people with melanomas that had spread, giving some a lower dose and others a higher dose of the new drug. The study showed that tumors shrank in 38% of all those treated and in 52% of those treated with the higher dose. While the side effects were generally mild, 13% of those treated had more serious reactions, such as thyroid problems or lung or kidney inflammation. This clinical trial is currently recruiting new participants.

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New England Journal of Medicine│Jun 2, 2013

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PD-1 Antibody Demonstrated Encouraging Activity in Metastatic Melanoma

PD-1 Antibody Demonstrated Encouraging Activity in Metastatic Melanoma | Melanoma Dispatch | Scoop.it

"Heavily pretreated patients with metastatic melanoma who received the humanized anti-PD-1 monoclonal antibody pidilizumab demonstrated encouraging rates of 12-month OS, according to results of a phase 2 study presented at the ASCO Annual Meeting.


“ 'Activity was previously seen [with pidilizumab] in two lymphoma populations in phase 2 studies,' researcher Michael B. Atkins, MD, deputy director of Georgetown-Lombardi Comprehensive Cancer Center in Washington, and professor of oncology and medicine at Georgetown University School of Medicine, said during a presentation. 'Correlative studies in those lymphoma populations supported a PD-1/PD-L1–linked mechanism of action, and importantly there was no change or an increase in PD-1–positive CD4 and CD8 lymphocytes and CD14 monocytes following the drug, excludingantibody-dependent cellular cytotoxicity of PD-1–positive cells as a consequence of therapy.' "


Editor's note: Pidilizumab is a new drug that that might benefit people with metastatic melanoma who have already been heavily treated. A recent clinical trial testing it in volunteer patients found some promising results, but further studies will be needed to see how to use pidilizumab most effectively, in terms of dosage and combining it with other drugs. Pidilizumab is an "anti-PD-1" immunotherapy, meaning that it interacts with a protein called PD-1 to boost a patient's own immune system to fight cancer. Learn more about immunotherapy treatments for melanoma at our Need to Know blog.

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Healio  |  Jun 24, 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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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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At Last, Success Seen in Fighting Cancer with the Immune System

At Last, Success Seen in Fighting Cancer with the Immune System | Melanoma Dispatch | Scoop.it

"Fundamental research -- much of it done in Boston -- has led to a shift in the scientific strategy for fighting some cancers, toward using drugs to activate a patient’s own immune system. An approach that was on the fringes of cancer therapy is suddenly the hottest trend in cancer drug development. On Monday, for example, Boston researchers presented data showing that nearly half of patients with advanced melanoma lived for two years after getting an experimental immune therapy called nivolumab, though multiple other therapies hadn’t worked for them. And drug companies have announced several deals recently to acquire companies developing immunotherapies. The frenzy of activity is an abrupt change for a field that had made big promises but failed to deliver for years."

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The Boston Globe  |  Mar 10, 2014

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PD-1 Blocker Extends Life in People with Melanoma in Early Trial

PD-1 Blocker Extends Life in People with Melanoma in Early Trial | Melanoma Dispatch | Scoop.it

An experimental immunotherapy may keep people with melanoma alive for up to 1 year, according to findings presented at the 2013 International Congress of the Society for Melanoma Research in Philadelphia, Pennsylvania. The drug (MK-3475) blocks a protein, called PD-1, that lets cancer cells evade the immune system. Researchers treated 135 people with MK-3475 and found that tumors shrank in 40% and disappeared in 9%. Altogether, this drug is being tested in more than 3,000 people with melanoma or breast, bladder, colorectal, or lung cancer. In addition, another experimental PD-1 blocker called nivolumab is being tested alone and in combination with the U.S. Food and Drug Administration (FDA)-approved Yervoy (ipilimumab) against melanoma and blood, breast, gastric, kidney, liver, lung, and pancreatic cancers.

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Bloomberg | Nov 18, 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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New Drug May Mobilize the Immune System to Attack Tumors

New Drug May Mobilize the Immune System to Attack Tumors | Melanoma Dispatch | Scoop.it

A new drug called MPDL3280A appears to shrink tumors in patients with a range of different cancers, including lung cancer and melanoma. In an ongoing clinical trial, MPDL3280A shrank tumors in 21% of patients with advanced cancer. Response rates were even higher in subsets of patients with lung cancer (22%) or melanoma (29%). Treatment benefits lasted from 3 to 15 months and counting; 26 of the 29 patients who benefited continue to respond to this day. There was wide variation in how quickly patients responded to treatment, with some experiencing significant improvement within days, and others after weeks of unresponsiveness. MPDL3280A was generally well tolerated, with few cases of severe side effects.

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ASCO Daily News | June 13, 2013

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ASCO Daily News | Jun 13, 2013

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Nivolumab Extends Life in Melanoma Patients in Early Trial

Nivolumab Extends Life in Melanoma Patients in Early Trial | Melanoma Dispatch | Scoop.it

An experimental immunotherapy drug called nivolumab may increase survival in people with melanomas that have spread. Nivolumab blocks a protein called PD-1, which lets tumor cells evade the immune system. In a phase I trial of melanoma patients who had not responded to previous treatments, researchers found tumors shrank in 41% of those given the highest dose of nivolumab (3 mg/kg). Overall, 62% survived to 1 year and 43% survived to 2 years and only 2% had severe side effects. Nivolumab is currently being tested in three phase III trials. These findings were among several advances in immunotherapy treatments for melanoma presented at the American Society of Clinical Oncology's 2013 meeting.

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OncLive│Jun 2, 2013

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