For the first time in history, the effectiveness of a womb cancer drug experiencing clinical trials has surprised everyone. It was a short trial with 18 rectal cancer patients who took the same Pill. But the outcomes were remarkable — tumors that had dispersed in the rectum more often to the lymph nodes while not to other organs.
The cancer disappeared in every patient, undetectable by physical exam; endoscopy; positron emission tomography, PET scans; or MRI scans. The small group of people with rectal cancer witnessed their cancer vanishing after the experimental treatment.
The drug, Dostarlimab, has cured every participant in the trial. According to the research report, the 18 patients in the short clinical trial took Dostarlimab for around six months, and after over 12 months, the doctors found that their cancer had disappeared.
The results were published in a New England Journal of Medicine paper. The paper lists the names of 32 authors.
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This study’s initial purpose was to determine whether the study drug, TSR-042 (commonly called dostarlimab), followed by standard chemoradiotherapy and traditional surgery is an effective treatment for advanced deficient Mismatch Repair (dMMR) solid tumors.
The Simon and Eve Colin Foundation supported the medical trial, Swim Across America, GlaxoSmithKline, Stand Up to Cancer, and the National Cancer Institute of the National Institutes of Health.
“It’s what cancer doctors’ dreams are made of,” Dr. Andrea Cercek, a co-author of the paper and an oncologist at the Memorial Sloan Kettering Cancer Centre in New York, said while speaking to CNN. Describing how the drug utilized in the trial works, she said, “Dostarlimab works by unlocking the body’s natural immune system to fight cancer. When we give immunotherapy like [with] dostarlimab, it ramps up the immune system to see cancer and get rid of it,” she added. “What’s remarkable here is that it eliminated cancer. The tumors just vanished.”
Another noteworthy highlight of the trial is that none of the participants reported significant severe side effects. According to The New York Times, around 3-5% of patients who take checkpoint inhibitors (like dostarlimab) show severe complications. The absence of significant side effects shows that they “either they did not treat enough patients or, somehow, these cancers are just plain different,” Dr. Alan P. Venook, a colorectal cancer specialist at the University of California, San Francisco, who was not involved with the study, was quoted as saying.
Commenting on the trial, Dr. Hannah K. Sanoff of North Carolina Cancer Hospital said that although the results are optimistic, the treatment procedure used in the study cannot replace the current curative treatment approach. “Patients who have a complete clinical response after chemotherapy and radiation therapy have a better prognosis than those who do not have a complete clinical response, yet cancer regrowth occurs in 20 to 30% of such patients when the cancer is managed nonoperatively,” she wrote in an editorial on trial. She also added that to provide further information on patients who might benefit from immunotherapy, subsequent attempts should aim for “heterogeneity in age, coexisting conditions, and tumor bulk.”
The study’s assessed primary completion date is November 30, 2023. The assessed date of the completion of the survey is November 30, 2025, according to the listing on clinicaltrials.gov.