Immunotherapy drug a "gamechanger" for head and neck cancer

An immunotherapy drug hailed as a potential “gamechanger” in the treatment of cancer could soon offer new hope to patients with currently untreatable forms of the disease.

Nivolumab was found to extend the lives of relapsed patients diagnosed with head and neck cancers who had run out of therapy options. After a year of treatment, 36% of trial patients treated with the drug were still alive compared with 17% of those given standard chemotherapy.

Patients with advanced head and neck cancers resistant to chemotherapy are notoriously difficult to treat and generally survive less than six months.

Trial participants treated with nivolumab typically survived for 7.5 months, and some for longer. Middle-range survival for patients on chemotherapy was 5.1 months.

The phase-three study, the last stage in the testing process before a new treatment is licensed, provided the first evidence of a drug improving survival in this group of patients.

Prof Kevin Harrington, from the Institute of Cancer Research, London, who led the British arm of the international trial, said: “Nivolumab could be a real gamechanger for patients with advanced head and neck cancer. This trial found that it can greatly extend life among a group of patients who have no existing treatment options, without worsening quality of life.

“Once it has relapsed or spread, head and neck cancer is extremely difficult to treat. So it’s great news that these results indicate we now have a new treatment that can significantly extend life, and I’m keen to see it enter the clinic as soon as possible.”

Before it can be offered on the NHS, the treatment will have to be approved by the European Medicines Agency and the National Institute for Health and Care Excellence (Nice), which vets new therapies in England and Wales for cost-effectiveness.

Of the 361 patients enrolled in the trial, 240 were given nivolumab while the remaining 121 received one of three different chemotherapies. UK patients were assigned the chemotherapy drug docetaxel, the only treatment currently approved for advanced head and neck cancer by Nice.

Patients whose tumours tested positive for the HPV virus, which is linked to cervical cancer and may be spread by oral sex, did especially well. They typically survived for 9.1 months, compared with 4.4 months when treated with chemotherapy.

The findings were simultaneously published in the New England Journal of Medicine and presented at the European Society for Medical Oncology (Esmo) conference in Copenhagen.

In 2012 around 11,000 new cases of head and neck cancer were diagnosed in the UK and 3,300 Britons died from the disease. The cancer can effect the lips, mouth, nasal cavity, back of the throat, and voice box.

More than half of patients relapse within three to five years.

Nivolumab is one of a new class of antibody drugs called “checkpoint inhibitors” that help the immune system fight cancer. It works by blocking signals from tumour cells that stop the immune system attacking.

The drug is already licensed for the treatment of advanced melanoma skin cancer and non-small-cell lung cancer in the UK.

However while Nice has backed its use on the NHS for melanoma it has so far refused to recommend making the drug freely available to lung cancer patients.

Prof Paul Workman, chief executive of the Institute of Cancer Research, said: “Nivolumab is one of a new wave of immunotherapies that are beginning to have an impact across cancer treatment. This phase-three clinical trial expands the repertoire of nivolumab even further, showing that it is the first treatment to have significant benefits in relapsed head and neck cancer.

“We hope regulators can work with the manufacturer to avoid delays in getting this drug to patients who have no effective treatment options left to them.”

Immunotherapy drug a "gamechanger" for head and neck cancer

What is immunotherapy?

What is immunotherapy?

Immunotherapy is a drug treatment for cancer that stimulates the body’s immune system to recognise and attack tumours. The immune system fights off invading infections, but can miss cancer cells, which are mutated forms of normal cells within the body.

Does it work?

In recent years, there has been a slew of exciting studies showing that immunotherapy does work – after decades of fruitless attempts. In melanoma, a form of skin cancer, in lung cancers and in several other forms, immunotherapy drugs have been successfully used to alert the immune system to the presence of cancer cells.

Is it a cure?

Scientists say it is still too early to tell, but there are now people who had advanced forms of disease and were expected to die before they joined an immunotherapy trial, living as long as 10 years with no sign of cancer.

Does it help everybody?

No. That is one of the biggest issues now facing scientists. Only a minority of patients get remission from their cancer – often about one in five. Important work is now going on to try to ascertain who will get the benefit and who will not – and why.

What about side-effects?

This is the other big issue exercising scientists. There are major side-effects from ipilimumab and pembrolizumab, the two leading immunotherapy drugs. These range from skin reactions and feeling sick through pain and muscle cramps to – rarely – kidney problems and potentially serious effects on the eyes, ears and skin. Some people have to stop taking the drugs because of them. Others need treatment for the side-effects for months afterwards.

Why does that happen?

The drugs take the brakes off the immune system so that it attacks the tumour, but it can also attack healthy tissue – it does not discriminate.

What is this new drug?

IMM-101 is called an “immune modulator”. It was originally being developed as a cancer vaccine, but was thought to have potential as an immunotherapy. It contains an inactivated bacterium.

Does it have any advantages over current immunotherapy drugs?

It appears to have no side-effects, which is a very positive thing. No other immunotherapy drug has been developed with no toxicity.

What cancers has it been trialled in?

So far, only an early study in melanoma and the new study in pancreatic cancer. It has produced good results in both but not enough to get it a licence. That will take a bigger trial with more patients than the 110 in the pancreatic cancer study.

Does this new drug cure pancreatic cancer?

No. It is a very difficult disease with only 4% of patients surviving for five years. But the trial shows that patients with metastatic cancer – where it has spread beyond the pancreas to other parts of the body – survived for an extra 2.6 months. That was the median, but some lived for a couple of years longer.

What happens next?

A bigger trial for patients with metastatic pancreatic cancer to be sure it extends life.

What is immunotherapy?

Jimmy Carter, Melanoma, And The Guarantee Of Immunotherapy In The Elderly

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Former president Jimmy Carter is obtaining Merck’s new immunotherapy drug to deal with his melanoma, displaying just how critical these treatment options might be for elderly sufferers with constrained alternatives.

Jimmy Carter, Melanoma, And The Guarantee Of Immunotherapy In The Elderly

Oral Immunotherapy May Hold Guarantee For Youngsters With Peanut Allergy

Primarily based on final results of a phase II trial recently published in in Lancet, oral immunotherapy (OIT) in children with peanut allergy is linked with a substantial charge of desensitization.  Desensitization indicates that a kid will have no response when he or she eats peanuts- such as itching, hives or any much more severe signs and symptoms this kind of as lip or tongue swelling.

This suggests that this mode of therapy may possibly probably be beneficial with people struggling from peanut allergy, a life threatening and probably deadly foods allergy.

One particular hundred children between the ages of 7 and sixteen with peanut allergy have been randomized to normal care (avoiding peanuts) or 26 weeks of oral immunotherapy.  This consisted of daily doses of peanut flour which elevated over a period of time, up to a maintenance dose of 800 mg/day.

Benefits from the trial indicate that following 26 weeks, 62% of patients in the treatment method group have been desensitized. This signifies that no response was reported in the course of a blinded foods challenge of 1400 mg.  Based on results, no individuals in the control group were desensitized.  Itching  in and all around the mouth was the most widespread side result mentioned and occurred after six% of doses administered. Intramuscular epinephrine had to be administered two occasions throughout the trial, with no deaths or problems reported.

Despite the fact that OIT for peanut allergy is not appropriate for mainstream clinical use, the results from this trial are really encouraging.  Undoubtedly more investigation demands to be done on the mechanism of action, such as short and long phrase effects of the treatment, outcomes, as effectively as greater scale testing of such protocols.

The bottom line is that this should be accomplished in a systematic and cautious way through cautiously designed trials to make an successful and lasting approach without having any outside industry pressures.

Meals Allergies-The Implications

Foods allergy is a probably life threatening as effectively as a life altering problem which impacts up to 15 million Americans. Although there are a number of probably lifestyle threatening therapies (epinephrine, antihistamines and steroids) for its profound signs, there is no “cure” to prevent anaphylaxis–potentially deadly response involving the release of histamine top to reduced blood stress airway swelling and inability to breath.  The reality is that a trace volume of a food substance can trigger deadly anaphylaxis inside of minutes of ingestion. Meals allergic reactions build when the body’s immune method mistakenly targets a harmless foods protein or an allergen and perceives it as a threat.

Mild signs can assortment from a red rash or hives, to eczema or gastrointestinal symptoms this kind of as nausea and vomiting or diarrhea or an itchy mouth or ears. Signs and symptoms of anaphylaxis consist of swelling of the lips or tongue or throat trouble swallowing along with shortness of breath or wheezing., or even reduced blood stress or reduction of consciousness. Epinephrine is the only medicine which can deal with and reverse the signs and symptoms of anaphylaxis. It can be provided as an auto injector-and can be offered at the 1st signal of any extreme allergic reaction. It is crucial to phone 911 and go to the nearest emergency department even if the symptoms seem to get started resolving because there may be a recurrence within a brief time period soon after the medications wears off.

While folks can be allergic to any type of food, eight foods account for practically 90 % of all allergic reactions to foods in the US. (egg, milk, peanut, tree nuts, wheat, fish, soy, shellfish). The bottom line is that a individual can develop a foods allergy anytime, at any age nevertheless, the affect on toddlers and kids along with their families, is most pronounced.

FARE to the Rescue

According to latest information from FARE (Food Allergy Study and Schooling), a top national organization based mostly in New York City, and focused to food allergy investigation, education, advocacy and awareness, 1 in 13 US youngsters has a food allergy- practically two kids for every classroom. In addition, virtually forty% of young children with foods allergies have currently experienced anaphylaxis. Every 3 minutes, a meals allergy will lead to an emergency division go to. An last but not least, there has been nearly a 50 percent enhance in childhood meals allergy symptoms between 1997 and 2011, top to 25 billion bucks per 12 months in related health expenses to treatment and diagnosis.

FARE’s mission and goals– to assist make a difference in the every day lives of those impacted by meals allergies– reaches far and broad.  Founded by Elliot Jaffe, FARE has manufactured considerable contributions in research, training, advocacy, as well as marketing awareness of food allergic reactions throughout not only the US, but also all through the globe.

According to John L. Lehr, CEO of FARE, “Our vision is to make the globe protected for men and women with foods allergy symptoms. We are committed to finding a remedy for meals allergy symptoms, and to retaining people with food allergic reactions risk-free and included”.

“In our pursuit of a cure, we invest in globe-class research to boost therapy and understanding of the disease. We have a strategic program centered on accelerating the development of safe therapies that will protect individuals from daily life-threatening reactions” explained Lehr.

Lehr explained that FARE is functioning to broaden the number of very competent centers conducting clinical research, and to boost the variety of therapies below study and the variety of clinical trials underway by facilitating the collaboration between analysis centers.

Oral Immunotherapy May Hold Guarantee For Youngsters With Peanut Allergy