Doctors left shocked after clinical trial for cancer drug cures the disease in every participant 

A new colorectal cancer drug has shocked researchers with how effective it is against the highly dangerous disease after it cured virtually every member of a clinical trial.

Dostarlimab, a monoclonal antibody drug already approved for the treatment of endometrial cancer in the UK, exceeded expectations in a trial at Memorial Sloan Kettering Cancer Center in New York.

A year after the trial ended, the cancers of each of the 18 participants had gone into remission, with doctors finding no signs of cancer in their bodies.

Although the trial was small, it is considered groundbreaking and the drug is being set up as a possible cure for one of the most dangerous common cancers known.

However, dostarlimab can only be used in up to one-tenth of colorectal cancer patients who have a genetic mutation in their tumor, which all study participants had.

dr. Luis Diaz, one of the lead authors of the paper, 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 big step forward for patients.’

dr. Diaz, who is also a member of the White House’s National Cancer Advisory Board, told the New York Times that the discovery was “the tip of the iceberg.”

“We are investigating whether the same method could help other cancers, where the treatments are often life-altering and tumors could be MMRd,” he said.

“We are currently enrolling patients with gastric (stomach), prostate and pancreatic cancer.”

dr.  Luis Diaz (second from left) and Dr.  Andrea Cercek (fourth from left) standing with some of their patients.  From left: Sascha Roth, Imtiaz Hussain, Avery Holmes and Nisha Varughese

dr. Luis Diaz (second from left) and Dr. Andrea Cercek (fourth from left) standing 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)

A recent clinical trial of the drug dostarlimab, a monoclonal antibody, found that it virtually cured cancer in every participant (file photo)

HOW 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 recognize and attack the cancer.

A 500 mg dose of the drug is infused into a vein into the bloodstream over a period of 30 minutes.

The treatment can cause mild side effects, including rash, dry and itchy skin, fatigue, and nausea.

It is already being 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 study of 18 colorectal cancer patients in the US, it was administered every three weeks for six months.

Dostarlimab costs about $11,000 per 500 mg dose in the US. In the UK it is sold for £5,887 per dose.

However, the NHS has agreed a discount with manufacturer GlaxoSmithKline.

About 43,000 Britons and 150,000 Americans are diagnosed with colon cancer every year.

The cancer, which kills 17,000 people in the UK and 53,000 in the US, is one of the five most common cancers in both countries.

Dostarlimab can be used in patients with tumors with a specific genetic makeup known as mismatch repair deficiency (MMRd) or microsatellite instability (MSI).

Only five to ten percent of all rectal cancer patients would have MMRd tumors, including all patients in the clinical trial.

The monoclonal antibody works by attaching to a protein called PD-1 on the surface of cancer cells.

This helps the immune system to effectively ‘unmask’ and destroy cancer cells.

The 18 patients had all undergone previous colorectal cancer treatments before the trial, including chemotherapy and high-risk surgery.

Patients enrolled in the study received treatments with monoclonal antibodies every three weeks for six months.

Researchers followed up the patients 12 months later and the cancer had apparently cleared from their bodies, with the medical staff unable to find any signs of tumors with any of the available screening methods.

Dostarlimab costs about $11,000 per 500 mg dose in the US. In the UK it is sold for £5,887 per dose.

However, the NHS has agreed a discount with manufacturer GlaxoSmithKline (GSK), which sponsored the US trial, for the treatment of advanced endometrial cancer.

Dostarlimab is given to approximately 100 patients with advanced endometrial cancer each year. The life-prolonging drug aims to improve their quality of life and avoid chemotherapy, which has more side effects and limited benefit.

dr. Diaz said: ‘Our message is: if you have rectal cancer, get yourself tested to see if the tumor is MMRd.

“It doesn’t matter what stage the cancer is at, we have a trial at Memorial Sloan Kettering that can help you. And MSK has special expertise that really matters.’

“At the time of this report, no patients had received chemoradiation or 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 many happy tears,” said Dr. Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center and co-author of the paper, presented Sunday at the American Society of Clinical Oncology’s annual meeting.

No further 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 gosh, I get to keep all of my normal bodily functions that I feared I would. losses from radiation or surgery,” said Dr. Cercek.

Cercek takes a selfie with one of her patients, Imtiaz Hussain

Cercek takes a selfie with one of her patients, Imtiaz Hussain

Sascha Roth was the first person to participate in Memorial Sloan Kettering's clinical trial for rectal cancer

Sascha Roth was the first person to participate in Memorial Sloan Kettering’s clinical trial for rectal cancer

While the study's results are groundbreaking, researchers note that the sample size was relatively small and more research will be needed to determine whether they have actually stumbled upon cancer treatment (file photo)

While the study’s results are groundbreaking, researchers note that the sample size was relatively small and more research will be needed to determine whether they have actually stumbled upon cancer treatment (file photo)

Colorectal Cancer: Cases and Survival Rates

Signs and symptoms may include blood in the stool, a change in bowel habits, 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 colon cancer

Five-year survival rate, if not staggered:

US = 90 percent

UK = 65 percent

screening:

US = for anyone 45 years or older, or younger if family history or aggravating factors

UK = from 60 years, or younger if medically necessary

As a result, all participating patients were able to avoid undergoing more dangerous, burdensome treatments.

†[The results] allowed us to forgo both chemoradiation and surgery and just observe,” the researchers wrote.

Surgery and radiation can have lasting effects on fertility, sexual health, and bowel and bladder function.

“The implications for quality of life are significant, especially in patients in whom standard treatment would affect fertility.”

The treatment caused mild side effects, including rash, dry and itchy skin, fatigue and nausea.

About 20 percent of the participants felt an adverse effect, but they were easily controlled.

While this study is groundbreaking and it looks like doctors may have stumbled upon a cancer cure, they know it’s too early to call it a miracle cure.

The researchers noted that the results are “promising” but need to be replicated in larger studies.

dr. Hanna Sanoff of the Lineberger Comprehensive Cancer Center at the University of North Carolina said the results were “small but compelling.”

dr. Sanoff, who was not involved in the study, said it is not clear whether the patients have recovered.

“Very little is known about the length of time it takes to find out whether a clinically complete response to dostarlimab equates to a cure,” she said in an editorial.

The first patient out of 18 was Sascha Roth, then 38, who noticed some rectal bleeding in 2019 but was feeling fine.

She had a sigmoidoscopy — a test to look inside the lower part of the gut — and her gastroenterologist said, “Oh no. I did not expect this.’

Mrs. Roth’s doctor called the next day and said to her, “It’s definitely cancer.”

Ms. Roth told the New York Times, “I’m totally broke.”

She was going to start chemotherapy at Georgetown University, but a friend recommended that she see Dr. Philip Paty featured on Memorial Sloan Kettering, who then told her her cancer contained the mutation that made it unlikely she would respond well to chemotherapy.

However, she was eligible to start the trial with dostarlimab.

Ms. Roth didn’t expect the trial to work and planned to move to New York for radiation, chemotherapy and possibly surgery after the trial ended — even if her ovaries were removed and replaced under her ribs to preserve them.

After the trial, Dr. Cercek told her the good news.

“We’ve looked at your scans,” she said. “There is absolutely no cancer.”

Roth added, “I’ve told my family. They didn’t believe me.’

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