AstraZeneca is currently conducting two separate studies on its new cancer drug, Tagrisso (sufficitose), which also has the potential to prevent COVID-19, a non-Hodgkin’s lymphoma (NHL) gene mutation. These trials are expected to wrap up in 2020, and the company is attempting to minimize the time that the drug would have to be on the market before being approved.
In both trials, dubbed Subcutaneous Treatment on Progression-Free Survival (CORAL-PS), and Prolacria on Advantages of Continued Intravenous Support, the placebo group is administered a single intravenous infusions of T790M, the only drug proven to prevent the mutation. The subjects in these trials had no other symptoms and received the drug immediately after chemo treatment, often to prevent relapse, leaving them with the option of initiating oral chemotherapy, which they often do not like.
For this study, the investigators reported that 66 percent of patients who received T790M antibodies died of a curable condition in the placebo group, or median overall survival was 34.1 months (22 months for survivors who had no new treatment). In the people receiving Tagrisso, there was a median overall survival of 46.5 months for the 57 percent of patients who had not relapsed within six months. Patients who had no relapse had similar levels of overall survival, clocking in at 50.8 months.
The researchers are also participating in a second trial known as Previlon, which has the potential to prevent COVID-19 by regulating immune system B cells with Arzoxib, a T-cell modulator from Pfizer. The FDA has already approved this drug for an oral use and hopes to allow it to be used in combination with Tagrisso.
The results of the new studies are promising, but the application is still years away. Even if a second approval is granted, the new therapy would still require patients to continue taking drugs in order to stop the likelihood of them developing the cancer. The two new trials must still be approved by the FDA, according to the trial protocol, and AstraZeneca would need to pay for the anti-COVID-19 drugs, as these were some of the expenses it incurred during the original trials. The company would also likely have to follow these patients for five years.
“On an absolute basis, Tagrisso is preventing colon cancer-like transplants, but the concept of lengthening the median survival is just speculative,” said Arthur Kadel, a biopharmaceutical analyst with Edward Jones & Co. Inc. “The only way to prove it is to extend the median survival by a couple months, or to see reduction in symptoms or other potentially different effects.”
Part of the reason why Tagrisso is so effective at preventing recurrence is because the mutation can only be detected in certain parts of the body, such as the liver, for instance. The goal is to find a drug that can find the mutation in the blood and then treat the part of the body that is under attack.
“Treatment is already there for Hodgkin’s lymphoma, it’s just that the pharmaceutical companies are targeting a small group of people,” said Dr. Ira Byock, a Tufts University radiation oncologist. “Any person with one mutation is at risk, but if you identify a couple people who are the highest risk, your success rate is almost 100 percent.”
“If you can do it earlier, we can treat them, and when we’re able to stop the progression of this disease, we’re far more likely to live the five-year life expectancy we want to have for this patient group,” he added.