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A new colon cancer drug has shocked researchers with its effectiveness against the highly dangerous disease, virtually curing it in every member of a clinical trial.
Dostarlimab, a monoclonal antibody drug, exceeded expectations in a recent trial conducted by Memorial Sloan Kettering Cancer Center in New York and sponsored by pharmaceutical giant GlaxoSmithKline (GSK).
A year after the study was completed, each of the 18 participants' disease went into complete remission, with doctors finding no signs of the cancer in their bodies.
“I believe this is the first time in the history of cancer,” said Dr. Luis Diaz, one of the study's lead authors and an oncologist at Memorial Sloan Kettering Cancer Center.
“It’s really exciting,” said Diaz, a member of the White House National Cancer Advisory Board.
“I think this is a big step forward for patients.”
He told that New York Times the discovery was “the tip of the iceberg.”
Although the study was small, it is considered groundbreaking and establishes the drug as a potential cure for one of the most dangerous types of cancer known.
“We are studying whether the same method can help other types of cancer, where treatments are often life-changing and tumors can be MMRd,” he said.
“We are currently accepting patients with stomach, prostate and pancreatic cancer.”
Dr. Luis Diaz (second from left) and Dr. Andrea Cercek (fourth from left) standing with some of her 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 cured cancer in virtually every participant (file photo)
The treatment applies to those with tumors with a specific genetic makeup known as mismatch repair deficient (MMRd) or microsatellite instability (MSI).
Between five and ten percent of all rectal cancer patients are thought to have MMRd tumors, including all patients in the clinical trial.
“Our message is: If you have rectal cancer, get tested to see if the tumor is MMRd,” Diaz said.
“No matter what stage the cancer is, we have a study at Memorial Sloan Kettering that can help you.
'And MSK has specialist know-how that really counts.'
All 18 patients had undergone previous colorectal cancer treatments before the study, including chemotherapy and risky surgeries.
These painful, life-altering processes are generally associated with colon cancer - a devastating diagnosis that is estimated to affect 150,000 Americans each year Cancer.net.
It is the third most common cancer in the United States and kills about 50,000 people each year - the second highest of all cancers.
Patients included in the study received monoclonal antibody treatments every three weeks for six months.
It costs about $11,000 per dose.
The drug effectively “unmasks” hidden cancer cells, which then allows the immune system to identify and destroy them.
Researchers examined the patients 12 months later, and the cancer appeared to be gone from their bodies because medical staff could not find signs of tumors using any of the available screening methods.
“At the time of this report, no patient had received chemoradiotherapy or undergone surgery, and no cases of progression or recurrence during follow-up were reported,” the researchers wrote in the study published in the New England Journal of Medicine.
“There were a lot of tears of joy,” said Dr. Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center and co-author of the paper, presented Sunday at the annual meeting of the American Society of Clinical Oncology.
Furthermore, no further treatments were required.
“It's incredibly rewarding to get these tears of joy and happy emails from the patients in this study who complete treatment and realize, 'Oh my God, I can keep all of my normal body functions that I was worried I might lose through radiation or surgery,'" Cercek said.
Cercek takes a selfie with one of her patients, Imtiaz Hussain
Sascha Roth was the first person to participate in the Memorial Sloan Kettering clinical trial for rectal cancer
Although the study's results are groundbreaking, the researchers note that the sample size was relatively small and it will require more research to determine whether they have actually stumbled upon a cancer cure (stock photo).
As a result, all participating patients were able to avoid more dangerous and strenuous treatments.
'[The results] allowed us to omit both chemoradiotherapy and surgery and proceed with observation only,' the researchers wrote.
Surgery and radiation can have lasting effects on fertility, sexual health, and bowel and bladder function.
“The impact on quality of life is significant, particularly in patients for whom standard treatment would compromise their childbearing potential.”
The treatment was also associated with limited negative side effects.
About 20 percent of participants experienced an adverse effect, but it was easily managed.
Although this study is groundbreaking and it looks like doctors have stumbled upon a cancer cure, they know it's too early to declare this a miracle cure.
"Although the results of our study are promising, particularly given that 12 consecutive patients all had a clinical complete response, the study is small and represents the experience of a single institution," they wrote.
“These results need to be replicated in a larger prospective cohort that balances academic and community practices and ensures the participation of patients from diverse racial and ethnic backgrounds.”
Dr. Hanna K. Sanoff of the University of North Carolina Lineberger Comprehensive Cancer Center said the results were “small but compelling.”
Sanoff, who was not involved in the study, said it was not clear whether the patients were cured.
“Very little is known about the time required to determine whether a clinical complete response to dostarlimab equates to a cure,” she said in the editorial.
The first patient of the 18 was Sascha Roth, then 38, who noticed some rectal bleeding in 2019 but was feeling well.
She had a sigmoidoscopy and her gastroenterologist said, 'Oh no. I wasn't expecting that!'
Roth's doctor called the next day and told her, "It's definitely cancer."
Roth told the New York Times, “I completely melted down.”
She was scheduled to begin chemotherapy at Georgetown University, but a friend recommended that she see Dr. Philip Paty at Memorial Sloan Kettering, who then told her that her cancer contained the mutation that made it unlikely that she would respond well to chemotherapy.
However, she was eligible to start the study with dostarlimab.
Roth didn't expect the trial to work and had planned to move to New York after the trial was completed for radiation, chemotherapy and possibly surgery - even having her ovaries removed and placed back under her ribs to preserve them.
After the hearing, Dr. Cercek her the good news.
"We've looked at your scans," she said. “There is absolutely no cancer.”
Roth added: "I told my family. They didn't believe me."