Indian origin patient among those 100% healed of rectal cancer in historic drug trial

An Indian origin patient, Nisha Varughese, was among the small group of patients with rectal cancer who got completely cured, after participating in a clinical trial for a drug called Dostarlimab for around six months, at Memorial Sloan Kettering Cancer Center in Manhattan.

The trial’s results, which is the first of its kind in medical history, appears to be a very promising breakthrough for the treatment of rectal cancer. Media reports quoted Varughese, who called the immunotherapy drug’s efficacy in curing her as a “miracle”.

The medication given, called dostarlimab and sold under the brand name Jemperli, is an immunotherapy drug used in the treatment of endometrial cancer. This was, however, the first clinical investigation to test if it was also effective against rectal cancer tumours.

According to the Memorial Sloan Kettering (MSK) Cancer Center in New York, after using dostarlimab, “the rectal cancer disappeared after immunotherapy – without the need for the standard treatments of radiation, surgery, or chemotherapy – and the cancer has not returned in any of the patients, who have been cancer-free for up to two years.”

The standard treatment for rectal cancer is surgery, radiation, and chemotherapy, which can be particularly hard on people because of the location of the tumor, said MSK medical oncologist Andrea Cercek, the first author of the study. And, they could suffer from life-altering bowel and bladder dysfunction, incontinence, infertility, sexual dysfunction, and more, she added.

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In an “amazing turn of luck”, the patients who enrolled in this trial did not have to undergo these procedures and their associated side effects. The results of the trial were disclosed in New England Journal of Medicine on June 5. An editorial in the Journal called it “an early glimpse of a revolutionary treatment shift”.

The findings are now making waves in the medical world. Colorectal cancer specialists at the University of California have called the complete remission in every single patient as something that is “unheard-of”. Moreover, not all of the patients suffered significant complications from the trial drug.

A co-author of the paper, oncologist Dr Andrea Cercek, described the moment patients discovered that they were cancer-free. “There were a lot of happy tears,” she told the New York Times.

Meanwhile, Varughese recalling the day she found out she was completely cancer-free said that day she didn’t see the tumour. So, she thought that maybe “it’s hiding somewhere inside”. It’s then the doctor told her, there is no more tumour. “It’s a miracle,” she said.

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It’s early days

This research was funded by numerous organisations, including the pharmaceutical company GlaxoSmithKline, which manufactures Jemperli. But, doctors pointed out that it isn’t over yet, and these were only preliminary results being reported so far.

At present, a total of 12 patients have completed the treatment and undergone at least six months of follow-up.

About three-quarters of patients so far have experienced mild or moderate side effects, including rash, itching, fatigue, and nausea – but none have so far seen a regrowth in cancer, with the median follow-up being at one year, and some patients have been being cancer-free for two years

Ultimately, the trial is expected to include about 30 patients. According to doctors, a fuller picture on the safety and effectiveness of dostarlimab is yet to emerge in patients with rectal cancer. A study has to be done on a broader groups of patients.

Until such time, we need to treat the current results with both optimism and caution, said oncologist Hanna K Sanoff from the University of North Carolina at Chapel Hill, who has written a commentary on the findings, according to media reports.

The reports quoted Sanoff as saying, “It’s early days, and there’s still a lot we don’t know, but if further research can replicate the bright promise hinted at here, we might be witnessing the development of a new kind of cancer therapy.”

How Dostarlimab works?

Dostarlimab is a drug with laboratory-produced molecules that act as substitute antibodies in the human body. For the trial, patients took Dostarlimab every three weeks for six months. The drug unmasks cancer cells, allowing the immune system to identify and destroy them.

Even though the treatment is looking promising, a larger-scale trial is needed to see if it will work for more patients and if the cancers are truly in remission.