LVHN taking part in clinical trial for cancer treatment
Drug used to treat colorectal cancer saw 100% remission in patients
Memorial Sloan Kettering Cancer Center made waves earlier this year when it announced the completion of a clinical trial that saw colorectal cancer in 18 patients disappear.
The patients received a drug that helped their immune system target and attack cancer cells, driving their cancer into remission and rendering it undetectable within six months.
Now, Lehigh Valley Health Network has joined a select group of networks and hospitals participating in the expanded clinical trial of the drug.
Dr. Suresh Nair, chief physician at LVHN’s Topper Cancer Institute, said patients already had been requesting the treatment; now LVHN will be able to offer it to those patients who qualify to participate.
“When this came out in the news in the summer, we had patients with all different types of cancer coming in and saying, ‘I want this treatment, the one with 100% response rate,’”) Nair said.
Miami Baptist Hospital in Florida and Hartford Healthcare in Connecticut are also participating in this expanded study, which aims to have about 100 participants and is expected to take a little less than a year to complete.
Nair said the expanded trial will make the treatment accessible to a wider, more diverse array of people who may benefit from it, and provide more comprehensive data on its effects.
“If you’re only doing it at just a couple of big city centers the patients may not be representative of the community or the nation at large,” Nair said. “You want to make sure that treatment works in everyday patients and all over the country. The Lehigh Valley is a good testing site because we have a mix of ethnicities, we have a mix of socio-economics and us being at a nonprofit hospital is a good thing, too.”
The trial, titled MSK 19-288, is open for sign-up through LVHN’s website. Nair said the network is screening existing patients for the trial but participation isn’t limited by geographic area, and they are hoping to let others outside the Lehigh Valley know this is available for them as well. No patients are so far enrolled.
Despite how promis
ing the treatment appears to be, the trial is only open to about 10% of colorectal cancer patients who experience a high level of mutation in tumor cells, Nair said.
Cancer is caused by damage to the DNA within cells resulting in gene mutations. Normally the body will fix damage or errors in DNA, but when it doesn’t, cancerous cells and malignant tumors can occur. Some people, whether it is because of inherited conditions or other factors, will experience high levels of mutation.
Rectal cancer has been treatable and curable for years. Early stages of colorectal cancer can be treated with a simple surgery that removes cancerous tissue; in later stages more advanced treatments like chemotherapy along with surgery are used.
Nair said this small group of colorectal cancer patients has proven difficult to treat with those methods, but this experimental treatment may reverse the trend if the results of this wider study stay in line with what was seen with the small trial.
This experimental procedure skips chemotherapy, radiation, surgery or other treatments and goes straight to using a monoclonal antibody drug called dostarlimab, which makes it easier for the body to fight these highly mutated cancer cells.
“The more mutated the tumor is from the rest of the cells, the easier it is for our T cells when they’re stimulated by the immunotherapy drug to just say, ‘You don’t belong, we’re going to attack you’+”) Nair said. “The cancer can cause some immune suppression, so this immunotherapy medicine takes the brakes off our T cells so that they can properly function.”
Besides its effectiveness, the treatment also isn’t invasive or particularly time-intensive — patients only need to receive infusions of the drug once every three weeks over a six-month period, and each infusion procedure only takes about 30 minutes to complete, Nair said. The infusion doesn’t temporarily affect cognitive or motor function either, which should make traveling for it easier for many.
He said cost shouldn’t be a barrier either. While each dose of the drug is about $11,000, federal law requires most health insurance plans to cover patient costs in clinical trials. Nair added that LVHN provides financial assistance to uninsured patients.
The side effects for this immunotherapy, though present for some, have been shown to be a bit more manageable compared to those associated with chemotherapy. If all goes well with this treatment patients also don’t have to worry about a colostomy bag or getting surgery that could cause problems with sexual, bowel or urinary dysfunction.
“With research, you can’t guarantee a 100% cure. This is still preliminary but it’s a chance for the patients who are eligible to have a less invasive type of treatment. Potentially they’ll still need monitoring, but potentially they’ll be avoiding surgery, chemo or radiation,” Nair said.