Melanoma: less ipilimumab, more nivolumab improves safety


Takeaway

  • Results from the phase 3b/4 CheckMate 511 trial suggest that a dosing regimen of nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (NIVO3+IPI1) is associated with improved safety but similar efficacy compared with nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (NIVO1+IPI3) for patients with unresectable stage III/IV melanoma.

Why this matters

  • These results suggest a superior safety profile for NIVO3+IPI1.

Key results

  • Patients treated with NIVO3+IPI1 had lower incidence of grade 3-5 treatment-related adverse events (TRAEs) compared with patients treated with NIVO1+IPI3 (33.9% vs 48.3%; P=.006; primary endpoint).
  • NIVO3+IPI1 and NIVO1+IPI3 were associated with similar objective response rates (45.6% vs 50.6%, respectively; P=.35).
  • NIVO3+IPI1 and NIVO1+IPI3 were associated with similar median PFS (9.92 vs 8.94 months; HR, 1.06; 95% CI, 0.79-1.42) and OS (not reached for both; HR, 1.09; 95% CI, 0.73-1.62).

Study design

  • 360 patients with previously untreated, unresectable stage III/IV melanoma were randomly assigned 1:1 to NIVO3+IPI1 or NIVO1+IPI3 once every 3 weeks for 4 doses.
  • 6 weeks after the last combination dose, patients received NIVO 480 mg once every 4 weeks until progression or unacceptable toxicity.
  • Funding: Bristol-Myers Squibb and ONO Pharmaceutical Company.

Limitations

  • Study not designed to formally demonstrate noninferiority for efficacy endpoints.

Cardiac Metastases in Melanoma


A 61-year-old woman was seen in the oncology clinic for evaluation of two cardiac masses found on annual surveillance with 18F-fluorodeoxyglucose–positron-emission tomography (FDG-PET) (Panel A). She was asymptomatic. Ten years earlier, biopsy of the nail bed of her left great toe revealed melanoma, which was surgically excised. She had local recurrence 7 years later, at which time she underwent amputation of the toe and received adjuvant treatment with ipilimumab. The current FDG-PET surveillance revealed FDG-avid masses within the left ventricle (Panel A, yellow arrow) and near the interventricular septum (Panel A, white arrow). No other FDG-avid sites were observed. Transthoracic echocardiography and computed tomography confirmed the presence of these two intramural lesions. An endovascular cardiac-biopsy specimen revealed melanoma metastatic to cardiac muscle, with tumor cells that were positive for a panel of melanocytic markers, including SOX10 (Panel B). Metastases to the heart from melanoma are rare, and cardiac involvement with no other sites of metastatic disease is rarer still. The patient started treatment with pembrolizumab, and follow-up imaging showed complete resolution of the cardiac metastases, with no new sites of disease. At follow-up 15 months after diagnosis, the patient continued to take pembrolizumab, with no recurrence of metastatic disease.

Novel Approach to Predicting Response to Immunotherapy in Melanoma


Researchers have created a gene-expression predictor that determines whether specific patients with melanoma are likely to respond to treatment with immune checkpoint inhibitors, based on a study conducted by Noam Auslander, MD, of the University of Maryland, and colleagues. Published in Nature Medicine, the study suggests that the new predictor, called IMPRES, appears to be accurate across many different melanoma patient data sets, unlike other existing predictors.

“There is a critical need to be able to predict how cancer patients will respond to this type of immunotherapy,” commented Eytan Ruppin, MD, PhD, of the National Cancer Institute’s (NCI) newly established Cancer Data Science Laboratory, who led the study, in a press release. “Being able to predict who is highly likely to respond and who isn’t will enable us to more accurately and precisely guide patients’ treatment.”

The researchers tested IMPRES (the immune-predictive score) on 297 samples from multiple studies. The higher the IMPRES score for a sample, the more likely it was to undergo spontaneous regression. They found that the predictor outperformed existing approaches, with an overall accuracy of AUC = 0.83. In addition, it seemed capable of diagnosing almost all patients who responded to the inhibitors and more than half of those who did not.

“We now know that immunotherapy works, but we do not understand well why a particular therapy will work for some patients but not others,” said Tom Misteli, PhD, Director of the Center for Cancer Research at NCI. “This study is a step forward in developing tools to address this challenge.”

The Truth About Melanoma and Skin Cancer: Facts and Common Myths


Often caused by excessive exposure to ultraviolet (UV) rays in sunlight, melanoma accounts for only 4 to 5 percent of skin cancer cases, but is responsible for most skin cancer-related deaths. As with many forms of cancer, melanoma is often misunderstood, and myths persist.

When detected and treated in its earliest stages, however, melanoma is often curable. The key is to avoid overexposure to UV rays – by limiting time outdoors during the peak hours of sunlight and wearing sun-protective clothing and sunscreen – and to be on the lookout for changes in moles and other blemishes that can be an early sign of the disease.

Jennifer Y. Lin, MD, of Dana-Farber Cancer Institute’s Melanoma Treatment Program, sets the record straight on five of the most common myths about melanoma.

Myth 1: A diagnosis of melanoma means that I have months to live.

There are four stages of melanoma — five if you include a form known as melanoma in situ, an early form of the disease that affects only the top layer of skin. Stage 1 melanomas, which are less than one millimeter thick and almost always have not spread beyond their original site, have an excellent prognosis and are generally cured by surgery. The depth of the original melanoma is critical to determining how it will be treated and how people with it are likely to fare. Although more melanomas are being diagnosed, the largest portion are made up of Stage 1 melanomas. Before worrying about the worst outcomes, speak with your doctor about what stage melanoma you have.

Myth 2: There is no difference between SPF 30 and SPF 100 sunscreen.

Although the baseline protection from SPF 30 and SPF 100 is not vastly different, the higher number provides longer coverage. (SPF stands for sun protection factor, or the amount of ultraviolet radiation the skin can absorb without burning while the sunscreen is on.)

If it normally takes you 10 minutes in the sun to burn, an SPF 30 sunscreen protects you for 300 minutes. An SPF 100 should, in theory, provide 1,000 minutes of coverage. If you are sweating and active, the sunscreen can rub off and should therefore be reapplied every two hours. When you are using a high SPF, there is a smaller likelihood of having a “missed spot.” A good way to know that you are applying enough sunscreen is to use the measurement of a shot glass of sunscreen for exposed sites.

Myth 3: If it is a cloudy day, I do not need to wear sunscreen.

About 80 percent of ultraviolet radiation reaches the earth even through clouds. Use a moisturizer with sunscreen daily, especially for areas that have high exposure, such as your face.

Myth 4: If I am low in vitamin D levels, I must get some sun exposure.

Although the skin is the most efficient site of vitamin D production, adequate amounts can be obtained from your diet and from supplements. Vitamin D helps you absorb calcium and build strong bones, so we frequently recommend supplements that include vitamin D and calcium.

Myth 5: If I have dark skin, I can’t burn and won’t get melanoma.

Even people with dark skin can burn if they’re exposed to the sun long enough. Although melanoma is much more rare in individuals of darker skin, it can occur. We recommend that darker-skinned individuals inspect their hands and feet once a month.

Source: Dana-Farber Cancer Institute.

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Why Are Black People Less Likely to Get Melanoma But More Likely to Die From It?


Having melanin doesn’t mean that you can’t get melanoma.
Jacqueline Smith after she was declared N.E.D.

Jacqueline Smith, a melanoma survivor, after doctors declared her status N.E.D., or “no evidence of disease.”

Jacqueline Smith was shocked when she received a stage III melanoma diagnosis at the young age of 21. As a black woman, she didn’t think it could happen to her. “Growing up, I learned that middle-aged, fair-skinned Caucasian women were at high risk for skin cancer,” Smith tells SELF. Smith, now 39, is a melanoma awareness advocate and public speaker who devotes much of her time to spreading knowledge of skin cancer risks, especially to other black women who may underestimate their chances of developing this potentially deadly disease.

Yes, black people can get skin cancer. What’s more, when they do, they’re much more likely to die from it.

“Skin cancer in [people] of color absolutely happens. It tends to be a perfect storm, which is why people who have darker skin and who develop skin cancer tend to have a much poorer prognosis,” dermatologist Brooke Jackson, M.D., who specializes in skin of color and owns a private practice in Durham, North Carolina, tells SELF.

A July 2016 study in the Journal of the American Academy of Dermatology found that of all racial groups, non-Hispanic black people had the lowest rates of melanoma diagnoses, but they were also the most likely to be diagnosed at a later stage.

The research pulled data from 96,953 patients given a melanoma diagnosis between 1992 and 2009. White people had the highest rate of skin cancer, with 45.8 diagnoses per 100,000 people, while black people had the lowest, with 1.35 diagnoses per 100,000 people. But despite the low incidence of melanoma in minority groups, these patients had significantly shorter survival rates than white patients.

According to the most recent data available from the American Cancer Society, the five-year melanoma survival rate is 93 percent for white people, but only 69 percent for their black counterparts.

There’s a whole host of complex reasons why black Americans are more likely to die from skin cancer than white Americans. To fully explore them, you first have to know a bit about what skin cancer really is.

Skin cancer happens when your skin cells grow abnormally and out of control. It’s the most common form of cancer in the United States.

Over 5 million people in the United States are diagnosed with skin cancer each year, according to the American Cancer Society’s 2017 report. The most common forms of this disease are basal cell carcinoma, squamous cell carcinoma, and melanoma.

Your skin’s outermost layer is called your epidermis, and it has three main types of cells, according to the American Cancer Society. The squamous cells in the outer part of your epidermis are flat and constantly slough off so new ones can take their place. Basal cells, which are deeper in the epidermis, divide to make new cells to replace the old squamous ones. Then there are melanocytes, which create melanin. It’s the brown pigment that, by making some people’s skin darker than others, allows for the human race to have such a beautifully diverse range in skin tones.

While everyone has a similar number of melanocytes, genetics determine how much of this pigment those cells actually make, according to the American Academy of Dermatology (AAD). The more melanin you have, the darker your skin.

The most prevalent types of skin cancer correspond with these different cells. Around 8 in 10 skin cancers in the United States are basal cell carcinomas, making this the most common form of this disease, according to the American Cancer Society. Basal cell carcinoma typically develops on areas most often exposed to the sun, like the head and neck, and grow slowly. They can present in a multitude of different ways, including as flat, firm, pale, or yellow areas, raised reddish patches, strange bumps, growths with raised edges, and open sores.

Squamous cell carcinoma, which makes up around 2 in 10 skin cancers, normally crops up on sun-exposed areas like the face, ears, neck, lips, and back of the hands, though it also sometimes shows up in the genital area. It often looks like a rough or scaly red patch, raised lump, open sore, or growth similar to a wart. Like basal cell carcinoma, it also grows slowly. The American Cancer Society estimates that these cancers kill around 2,000 people each year in the United States, although it’s hard to pinpoint the exact number of people who die from basal and squamous cell skin cancers annually because cancer registries don’t track them.

Melanoma, which starts in those pigment-providing melanocytes, can be much more lethal. “Melanoma isn’t the most common cancer, but we hear about it so often because it is the most deadly [skin cancer],” oncologist Michael K. Wong, M.D., Ph.D, a professor in the department of melanoma medical oncology at The University of Texas MD Anderson Cancer Center, tells SELF. Melanoma only makes up around 1 percent of skin cancers, but it’s expected to kill around 9,320 people in the United States in 2018. Melanoma is more likely to be fatal because it’s aggressive and typically quicker to spread when left untreated than basal and squamous cell skin cancers.

Melanoma usually shows up as a new mole on your skin that may change in size, shape, or color. Experts use what’s known the ABCDE rule to summarize melanoma warning signs: Asymmetry that means the mole doesn’t look uniform all over, a strange border around the mole’s edge, uneven color, a diameter larger than around ¼ inch, and a mole that is evolving in shape, size, or color.

Melanoma most often appears on the chest and back in men and the legs in women, though it can really occur almost anywhere on your body, according to the American Cancer Society. The most common form is superficial spreading melanoma, according to the U.S. National Library of Medicine. (This is what Smith had.)

Black people are actually more susceptible to the least common subtype of the disease, known as acral lentiginous melanoma. This kind of melanoma shows up in unexpected places, like the palms of the hands, soles of the feet, and under the nails. This unexpected presentation causes it to fly under the radar, which is one reason why black people are more likely to be diagnosed with skin cancer at a later stage. Another reason: the damaging myths about black people being exempt from skin cancer.

There’s a dangerous, pervasive, and categorically inaccurate idea that melanin offers sufficient protection from the sun’s harmful UV rays.

Until she received her diagnosis, Smith says she believed that since she had dark skin, she didn’t need to protect herself from the sun. “I hear all too often that melanin is our natural sunscreen,” she says. She’s far from alone; a 2015 study in the Journal of the American Academy of Dermatology found that non-Hispanic black women were significantly less likely to regularly protect their face or other exposed areas with sunscreen than non-Hispanic white women. Overall, sunscreen use was lowest in people whose skin didn’t tend to burn. But your skin doesn’t need to actually burn in order for you to have skin damage—even a slight tan after sun exposure is a sign your skin has been injured, according to the Centers for Disease Control and Prevention (CDC).

The authors of the study, which was a nationally representative survey of 4,033 people, posited that people whose skin isn’t as sensitive to the sun may think they don’t need sun protection. While the study had its limitations, like relying on people’s self-reported sunscreen use, it points to what experts say is a commonly held belief. “The misperception is that melanin is universally protective and [dark-skinned people] do not need to wear sunscreen,” Dr. Jackson says.

It’s true that melanin does offer some protection from the sun by absorbing or deflecting harmful ultraviolet rays (invisible radiation from the sun that can damage the DNA of genes that control skin cell growth)—but it’s not enough to completely ward off the threat of skin cancer, no matter how dark your skin may be.

That’s why sunscreen—and people knowing they need it—is essential; it absorbs, reflects, or scatters sunlight to protect against UV rays, according to the CDC. The American Cancer Society suggests wearing a broad spectrum sunscreen (meaning it protects against both UVA and UVB rays) with SPF 30 or higher. Experts also recommend wearing accessories like hats and sunglasses, long-sleeved clothing in dark colors (or even with SPF), and trying to stay in the shade between 10:00 A.M. and 4:00 P.M. when UV rays are most intense.

But dutifully slathering on sunscreen and taking other protective measures isn’t enough to completely ward off skin cancer. In fact, the acral lentiginous melanoma that is more likely to affect black people can show up in areas that are rarely exposed to the sun, like the bottoms of the feet. No one knows precisely what causes non-UV related skin cancer to develop, Dr. Jackson explains, but potential factors include gene mutations, a family history of cancer or skin cancer, and various inherited syndromes that raise skin cancer risk, according to the American Cancer Society.

But make no mistake—the racial disparities in skin cancer survival rates are not solely based on insufficient information and sunscreen. There are many more factors at play.

Factors tied to lower socioeconomic status, like a lack of access to preventive screenings, absent or low-quality health insurance, and poor medical care can translate into worse health outcomes for people of color, according to the American Cancer Society’s 2016-2018 report on cancer in African Americans. And without insurance, skin cancer screenings are likely to be an afterthought. According to the United States Census Bureau’s 2016 report, all non-white populations had higher uninsurance rates than white people: 16 percent of Hispanic-origin people were uninsured, compared with 10.5 percent of black people, 7.6 percent of Asian people, and 6.3 percent of white people.

Even the toll of combatting discrimination and racism can affect health disparities, as chronic socioeconomic and race-related stress may contribute to poorer health outcomes, according to the American Psychological Association.

Even when someone is able to access medical treatment, health professionals aren’t immune from the misperception that black people don’t need to worry as much about skin cancer. “Sometimes people who evaluate you are of the belief, ‘Oh, you’ve got dark skin—we don’t have to worry about you,’” Dr. Jackson says. And unfortunately, this can lead to delayed diagnosis and treatment. “There’s definitely a correlation between delayed diagnosis and poor prognosis,” Dr. Jackson says.

This is a lot of heavy, disheartening information. But that doesn’t mean all hope is lost: Prevention and detection make it possible to survive skin cancer.

Melanoma, as deadly as it can be, is most survivable when it’s found and treated as soon as possible.

To catch any strange spots as soon as they pop up, Dr. Wong emphasizes the importance of checking your skin regularly for any new marks. Anything that gives you pause is worth flagging for your doctor, but that’s especially true if you’re a black woman and find spots in areas where acral lentiginous melanoma is most likely to develop. If you see an unexplained, persistent mark on the soles of your feet, under your nails, or on the palms of your hands, make an appointment with your dermatologist, Dr. Wong says, and get a second opinion if you don’t feel they’re taking you seriously. The right doctor will fully evaluate both your mark and medical history, then potentially decide to remove the spot for a biopsy, according to the Mayo Clinic.

If you do in fact have skin cancer, your treatment will depend on the type and stage of your disease. In the early stages, your doctor may be able to surgically remove the cancerous skin without any additional treatment, according to the Mayo Clinic. If your cancer has spread, though, it may also require radiation or chemotherapy.

Thanks to her diagnosis and treatment, Smith is alive, well, and determined to help others avoid the same fate.

After surgery, a clinical drug trial, and radiation, Smith’s cancer status is N.E.D., or “no evidence of disease.” She now works with the Melanoma Research Foundation, is a commissioner on Maryland’s Montgomery County Commission on Health, and has served on the District of Columbia Cancer Action Partnership. She plans to make her life’s work helping other cancer patients through research and advocacy.

“I would like people to realize melanoma is largely preventable,” Smith says. “Had I known I would develop melanoma, I would have diligently used sunscreen and made a better effort to shield myself from sun exposure. However, I am thankful for my life and health, the people I’ve met along the way, and my overall journey.”

Is Itching a Sign of Cancer?


Itchy skin has many causes, including dryness and allergies, but only rarely does it signal that a person has cancer.

This symptom may occur as a result of complications of the disease, and itchy, flaky skin and rashes are common side effects of some cancer drugs. Most skin cancers, such as malignant melanoma, don’t normally cause itching.

Itchy skin has many causes, including dryness and allergies, but only rarely does it signal that a person has cancer.

 

 

One form of cancer in which itching is a prominent sign is polycythemia vera, one of several blood cancers known as myeloproliferative disorders. People with this disease may experience itchiness particularly after a warm bath or hot shower, but this is only one of many symptoms associated with polycythemia vera. Others are trouble breathing when lying down, dizziness, headache, fatigue, and others.

Scaly skin and red rashes may be an early sign of mycosis fungoides or Sezary Syndrome, which are forms of cutaneous T-cell lymphoma. Mycosis fungoides goes through a series of phases, beginning with red rashes that may last for months or years, followed by the development of bumps or hardened lesions on the skin, and eventually tumors that form on the skin and may be infected.

Pancreatic cancer is another disease where patients may experience itching, but itching in itself is not a sign of pancreatic cancer. Pancreatic cancer patients may experience itching if their tumor blocks the bile duct and causes jaundice, says Robert Mayer, MD, of Dana-Farber’s Gastrointestinal Cancer Treatment Center. When this occurs, chemicals in the bile can leak into the skin and cause itching.

Some cancer treatments may cause itching or rashes over the entire body or in isolated areas. This may be result from a hypersensitivity reaction during chemotherapy infusion. In some cases, itching may be a chronic side effect of treatments, including biologic agents, radiation therapy, and a variety of targeted drugs.

Groundbreaking Study: This Herb Could Be the Cure to 5 Different Types of Cancer Including Ovarian, Liver, Lung, and Melanoma


Also known as drumstick or Malunggay, the plant moringa is frequently used in South-Indian cuisine due to its unique texture and taste. The tree is found in Africa and Asia and all of its parts, i.e. the pods, fruits, flowers, roots, and bark are edible and they have an abundance of nutrients. Moringa is considered to be a very beneficial plant, however, do we know we? Let’s take a look at what it has to offer:

  • The seeds of moringa produce edible oil known as Ben oil and it’s very similar to the nutritive value of olive oil, i.e. it’s rich in antioxidants and has an indefinite shelf life, amazing, right?
  • Believe it or not, moringa has three times more iron than spinach!
  • Moringa tea is an excellent way to start the morning because it will increase your energy levels and you will have enough energy for the whole day
  • Moringa has four times more vitamin A than carrots and it’s also rich in beta-carotene
  • Moringa supplements made from moringa leaves and pods are much better than over-the-counter vitamins and supplements since they don’t contain synthetic ingredients
  • Moringa has twice more protein per gram than yogurt
  • Moringa is three times richer in potassium than bananas
  • Moringa has seven times more vitamin C than oranges
  • Moringa has four times more calcium than milk

How to prepare moringa tea:

 If you have the tree in your garden, harvest some fresh leaves and then leave them to dry at room temperature by putting them in a brown paper bag with few holes. Hang the bag in some cool area of your home. After 10 to 14 days, the leaves should be dry enough to use. Remove the leaves from the paper bag and shred or pulverize them.

Add some of the shredded moringa leaves to a cup; add boiling water, a bit of lemon, and honey. Stir the content and enjoy!

The benefits of moringa tea

Since it is rich in vitamin and antioxidants, this tea will clear your mind and increase your energy levels. This tea is a great replacement of your morning cup of coffee. Your body will be detoxified, your immune system nourished, and you will lose weight in a healthy way.

If you don’t have a moringa tree in your garden, you can always purchase store-bought moringa tea. However, buy only 100% organic tea and tea from trusted brands.

Source:http://organichealthminds.com

Melanoma Tx Tied to Neurologic Disorder


Serious adverse effect of Keytruda in two patients.

Researchers reported two cases of demyelinating polyradiculoneuropathy after treatment with pembrolizumab (Keytruda) for advanced melanoma.

The report, in a letter published Wednesday in the New England Journal of Medicine, raises concerns about serious, perhaps irreversible, and previously unknown adverse effects from this class of drug, which targets the PD-1 immune checkpoint pathway. These immunotherapies, offering a whole new way of attacking cancer, have generated excitement across the oncology community in recent years.

The first patient was receiving treatment for recurrent nasal-cavity melanoma, and developed symptoms consistent with Guillain-Barré syndrome 8 weeks after beginning pembrolizumab therapy (2 mg/kg every 3 weeks), according to Philippe Saiag, MD, PhD, of Versailles Saint-Quentin-en-Yvelines University in Versailles, France, and colleagues.

The second patient was undergoing treatment for metastatic melanoma, and developed chronic inflammatory demyelinating polyradiculoneuropathy 20 weeks after beginning pembrolizumab therapy (2 mg/kg every 3 weeks). The patient also received ipilimumab (Yervoy) and binimetinib, they wrote.

The first patient presented with several symptoms including paresthesia and hypoesthesia of all limbs before the third infusion of pembrolizumab; the second patient also had multiple symptoms, including paresthesias of the arms and neck pain, between the sixth and seventh infusions.

In both cases, pembrolizumab was discontinued. The first patient responded to treatment in that her neurologic symptoms reached a peak within 3 weeks and decreased over the next 2 months. However, in the second patient, treatement did not lead to improvement in neurologic symptoms over 13 months of follow-up, the authors reported.

“We conclude that the two conditions may be associated with pembrolizumab, since neither patient had evidence of infectious causes or a documented paraneoplastic syndrome,” they wrote.

They explained that since, “demyelinating polyradiculoneuropathies are believed to be a result of autoimmunization, we speculate that PD-1–blocking antibodies may trigger one or more of the complex immune mechanisms involved in this disease.”

Management of Brain Metastases in Patients With Melanoma


Abstract

Melanoma is the third most common systemic cancer that leads to brain metastases. The annual incidence of melanoma has increased over time, with brain metastases developing in 40% to 50% of patients with advanced melanoma. Traditional management of melanoma-related brain metastases has focused on symptom control as a result of the significant neurologic morbidity associated with the disease. Median overall survival for these patients, if untreated, is approximately 3 months. As with other brain metastases, a multidisciplinary treatment approach that includes surgery and radiation therapy is typically used, with historically little role for systemic, cytotoxic therapy. During the past decade, advancement within the field of genomics has led to the identification of melanoma-specific mutations, namely, v-Raf murine sarcoma viral oncogene homolog B and neuroblastoma RAS viral oncogene homolog, as well as to the development of agents that target these driver mutations. In addition, the advent of immunotherapies, specifically, agents that target cytotoxic T-lymphocyte antigen-4, anti–programmed death-1, and programmed death ligand-1, has increased the potential therapeutic options available to patients with both systemic and brain disease. With these advances, early trials have demonstrated improved overall survival in patients with brain metastases who receive these therapies either as single agents or as part of multimodality treatment regimens.

Melanoma Drug Boosting Survival for Many, Study Shows


A new drug for advancedmelanoma is dramatically shifting the odds in favor of patients, extending survival for many and even curing some.

Keytruda (pembrolizumab) helped keep four in 10 patients with advanced melanoma alive three years after starting treatment, according to the results of a new clinical trial.

The drug also caused complete remission in 15 percent of patients, and many remained cancer-free even after they quit taking Keytruda, said Dr. Caroline Robert, head of the dermatology unit at the Institut Gustave-Roussy in Paris, France.

Keytruda already has scored one very high-profile success — it’s one of the drugs taken by former President Jimmy Carter, 91, in his successful battle last year against melanoma that had spread to his brain.

However, the drug comes with a hefty price tag — an estimated $12,500 a month.

Prior to the advent of targeted therapies like Keytruda, advanced melanoma patients had an average survival prognosis of less than one year, Robert said.

“Pembrolizumab provides long-term survival benefit in patients with advanced melanoma, with 41 percent of patients alive at three years, which is so different from what we’ve come from,” Robert said. “We have durable responses in one-third of the patients, and we have complete responses that are durable even after stopping the treatment.”

The latest clinical trial findings, which are the first long-term follow-up results for Keytruda, are to be presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago next month. Research presented at meetings is typically considered preliminary until published in a peer-reviewed journal.

Cancer expert Dr. Don Dizon called the results “incredibly exciting.”

“I think it’s incredibly encouraging that we could see a potential cure in melanoma as evidenced by the very prolonged response rate and the durability of this response,” said Dizon. He is an ASCO spokesman and clinical co-director of gynecologic oncology at Massachusetts General Hospital in Boston.

Keytruda helps the body’s immune system locate and destroy tumor cells by thwarting a genetic cloaking mechanism that cancer has developed to avoid immune detection.

“It teaches the body’s own immune system how to fight and control melanoma,” said Dr. Michael Postow, an oncologist specializing in immunotherapy with Memorial Sloan Kettering Cancer Center in New York City.

Robert’s clinical trial involved 655 patients diagnosed with advanced melanoma. Three-fourths of the patients had received other treatments for their cancer prior to the study.

Participants received Keytruda either every two or three weeks. The drug is administered via IV.

Long-term follow-up showed that four out of 10 patients were alive three years after starting Keytruda, whether or not they had been previously treated.

Further, 95 patients went into complete remission after taking Keytruda, Robert said.

Of those patients, 61 stopped taking Keytruda after they were judged cancer-free, Robert said. Only two wound up relapsing.

About 8 percent of the patients dropped out of the study due to drug side effects, Robert said. The most common were fatigue (40 percent), itchiness (28 percent) and rash (23 percent).

But, Postow said, “Most patients get through the drug without any serious side effects.”

The main downside is the cost of the drug. The drug’s maker, Merck, has set the price at about $12,500 a month, or about $150,000 a year, according to The New York Times.

“It is pretty expensive, unfortunately,” Postow said.

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