Doctors are left stunned after cancer 'disappears' for EVERY patient in drug trial - raising hopes treatment is 'tip of the iceberg' and can be used to help people fighting other forms of the disease
Dostarlimab, a monoclonal antibody, works by attaching to a protein called PD-1 on the surface of cancer cells. This helps the immune system effectively 'unmask' hiding cancer cells and destroy them. The drug, which is made by GlaxoSmithKline, is given intravenously in a 500mg dose
By Mansur Shaheen @Daily Mail & Emily Craig @Mail Online
7 June 2022
Clinical trial of dostarlimab cured 18 patients in the US of colorectal cancer
One researcher said that it was the 'first time this has happened' in a cancer trial
It is still too early to declare the drug a cancer cure because the trial was small
Doctors are expanding trial for gastric, prostate and pancreatic cancer patients
A womb cancer drug has shocked experts with how effective it is against colorectal tumours, after it seemingly cured every patient in a trial.
The antibody therapy Dostarlimab, already approved for women in the UK, smashed expectations in a study at Memorial Sloan Kettering Cancer Center in New York.
All 18 colorectal cancer patients involved in the trial were still in remission one year after it finished, with no signs of tumour reformation.
Researchers said there were 'a lot of happy tears' among the participants. All 18 had been unsuccessfully treated with traditional therapies before signing up to the study.
While the trial was small, it sets up Dostarlimab as a potential cure for one of the most deadly common cancers.
Dr Luis Diaz, one of the lead researchers of the trial, said: 'I believe this is the first time this has happened in the history of cancer. It's really exciting. I think this is a great step forward for patients.'
Colorectal, or bowel, cancer, is the second most common cause of cancer deaths in the US, taking 50,000 lives a year. In the UK, around 16,000 Britons die each year.
There is no specific treatment for the disease, with patients reliant on surgery to remove tumours and chemo or radiotherapy to keep it away.
However, Dostarlimab — made by the British pharmaceutical giant GlaxoSmithKline — only works on a fraction of patients.
Dr Luis Diaz (second left) and Dr Andrea Cercek (fourth left) stand with some of their patients. From left: Sascha Roth, Imtiaz Hussain, Avery Holmes and Nisha Varughese
A recent clinical trial of the drug dostarlimab, a monoclonal antibody, found that it virtually cured cancer in every participant (file photo)
It targets cancers that have a gene mutation that prevents cells from repairing damage to DNA.
All 18 patients in the trial had this type of cancer, but overall it only affects just five to 10 per cent of patients with the disease.
But Dr Diaz, who is also a member of the White House's National Cancer Advisory Board, told the New York Times the discovery was 'the tip of the iceberg'.
The team now plan to investigate whether the drug can tackle other cancers in the same way.
'We are currently enrolling patients with gastric (stomach), prostate, and pancreatic cancers,' said Dr Diaz.
Around 43,000 Britons and 150,000 Americans are diagnosed with colorectal cancer every year.
Dostarlimab is made by designing antibodies in a lab to attach to proteins called PD-1 on the surface of cancer cells.
This helps the immune system effectively 'unmask' hiding cancer cells and destroy them.
The body makes antibodies on its own but the natural response is often not enough to tackle aggressive tumours.
Dostarlimab can be used in patients who have tumours with a specific genetic makeup known as mismatch repair-deficient (MMRd) or microsatellite instability (MSI).
Just five to 10 per cent of all bowel cancer patients are thought to have MMRd tumours, including all the patients in the clinical trial.
The 18 trial patients had all gone through previous treatments for colorectal cancer before the trial, including chemotherapy and surgeries.
They received Dostarlimab every three weeks for six months.
Researchers followed up with the patients 12 months later, and the cancer had seemingly vanished from their bodies, with the medical staff unable to find signs of tumours with any of the available screening methods.
Dostarlimab costs about $11,000 per 500mg dose in the US. In the UK, it is sold for £6,000 per dose.
However, the NHS has agreed a discount with manufacturer GSK, which sponsored the US trial, to treat advanced endometrial cancer.
Dostarlimab is given to around 100 advanced endometrial, or womb, cancer patients every year. The life-extending drug aims to improve their quality of life and avoid chemotherapy, which has more side effects and a limited benefit.
Dr Diaz said: 'Our message is: Get tested if you have rectal cancer to see if the tumour is MMRd.
'No matter what stage the cancer is, we have a trial at Memorial Sloan Kettering that may help you. And MSK has special expertise that really matters.'
'At the time of this report, no patients had received chemoradiotherapy or undergone surgery, and no cases of progression or recurrence had been reported during follow-up,' researchers wrote in the study published in the New England Journal of Medicine.
'There were a lot of happy tears,' said Dr Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center and a co-author of the paper, which was presented Sunday at the annual meeting of the American Society of Clinical Oncology.
Furthermore, no more treatments were required.
'It's incredibly rewarding to get these happy tears and happy emails from the patients in this study who finish treatment and realize, "Oh my God, I get to keep all my normal body functions that I feared I might lose to radiation or surgery", Dr Cercek said.
Cercek takes a selfie with one of her patients, Imtiaz Hussain
Sascha Roth was the first person to join the Memorial Sloan Kettering clinical trial for rectal cancer
While the results of the study are ground breaking, researchers note that the sample size was relatively small and it will take more research to determine whether they have actually stumbled on a cancer cure (file photo)
As a result, all of the participating patients were able to avoid going through more dangerous, taxing, treatments.
'[The results] enabled us to omit both chemoradiotherapy and surgery and to proceed with observation alone,' researchers wrote.
Surgery and radiation can have permanent effects on fertility, sexual health, and bowel and bladder function.
'The implications for quality of life are substantial, especially among patients in whom standard treatment would affect childbearing potential.'
The treatment triggered mild side-effects, including a rash, dry and itchy skin, fatigue and nausea.
Around 20 percent of participants felt an adverse effect, but they were easily managed.
While this study is ground breaking, and looks like doctors may have stumbled onto a cancer cure, they know it is too early to declare this a miracle drug.
The researchers noted that the results are 'promising' but need to be repeated in larger studies.
Dr Hanna Sanoff of the University of North Carolina's Lineberger Comprehensive Cancer Center, said the results were 'small but compelling.'
Dr Sanoff, who was not involved in the study, said it is not clear if the patients are cured.
'Very little is known about the duration of time needed to find out whether a clinical complete response to dostarlimab equates to cure,' she said in an editorial.
The first patient of the 18 was Sascha Roth, then 38, who noted some rectal bleeding in 2019 but felt fine.
She had a sigmoidoscopy — a test to look inside the lower part of the bowel — and her gastroenterologist said: 'Oh no. I was not expecting this.'
Ms Roth's doctor called the next day, and told her: 'It's definitely cancer.'
Ms Roth told the New York Times: 'I completely melted down.'
She was due to begin chemotherapy at Georgetown University, but a friend recommend she first see Dr Philip Paty at Memorial Sloan Kettering, who then told her that her cancer included the mutation that made it unlikely to respond well to chemotherapy.
She was, however, eligible to begin the trial with dostarlimab.
Ms Roth did not expect the trial to work, and had planned to move to New York for radiation, chemotherapy and possibly surgery after the trial ended - even having her ovaries removed and put back under her ribs to preserve them.
After the trial, Dr Cercek told her the good news.
'We looked at your scans,' she said. 'There is absolutely no cancer.'
Roth added: 'I told my family. They didn't believe me.'
HOW DOES DOSTARLIMAB WORK?
Dostarlimab (also known as TSR-042) is a type of immunotherapy called a monoclonal antibody.
It works by attaching to a protein called PD-1 on the surface of cancer cells.
This helps the immune system to recognise and attack the cancer.
A 500mg dose of he drug is administered into the blood stream through a drip into a vein over a 30-minute period.
The treatment can trigger mild side-effects, including a rash, dry and itchy skin, fatigue and nausea.
It is already used to treat around 100 women with advanced endometrial cancer in the UK. For these patients, the drug is given every three weeks for 12 weeks.
In the trial involving 18 colorectal cancer patients in the US, it was administered every three weeks for six months.
Dostarlimab costs about $11,000 per 500mg dose in the US. In the UK, it is sold for £5,887 per dose.
However, the NHS has agreed a discount with the manufacturer GlaxoSmithKline.
Colorectal cancer: cases and survival rates
Signs and symptoms may include blood in the stool, a change in bowel movements, weight loss, and fatigue.
Every year, in the US:
106,180 new cases of colon cancer
44,850 new cases of rectal cancer
Every year, in the UK:
43,000 new cases of bowel cancer
Five year survival rate, if not spread:
US = 90 percent
UK = 65 percent
US = for all aged 45 or over, or younger if family history or aggravating factors
UK = from the age of 60, or younger if medically necessary
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