A cutting-edge vaccine against cancer failed to improve survival rates in a massive clinical trial in 20,000 patients, according to data presented on Monday.
Researchers at the National Cancer Institute reported that the patient deaths were 36 percent higher than in a control group when the vaccine’s effectiveness was assessed, largely because of a fall in the number of people alive three years after an initial cancer diagnosis. The large first trial, the largest of its kind, aimed to show that cancer immunotherapy is the future of treatment for certain cancers, but the news raises questions about the effectiveness of the experimental shot, developed by Cambridge, Mass.-based Moderna Therapeutics, the first company to attempt to harness the power of messenger RNA for cancer prevention.
The jab, or messenger RNA, is intended to prevent cancer from developing in the first place by affecting an individual’s ability to produce the tumor-suppressing protein known as tumor necrosis factor (TNF) that may otherwise be ignored in treating tumors.
To do this, Moderna injected patients with fragments of the molecule encoding TNF that cannot be produced naturally, hoping they would react by producing tumor-suppressing antibodies. The treatment worked well in some patients, but researchers struggled to spot a specific link between the TNF fragments and improved survival.
Their tests revealed a general lack of influence on patients, but the fall in overall survival rates looks even more alarming. By two years after initial diagnosis, there were 1,284 patients who had been immunized against cancer and 1,038 patients in the control group, for a statistically significant difference of 36 percent, according to data presented at the European Society for Medical Oncology Congress. When patients died on average three years later, there were 887 whose deaths had been attributed to the drug and 1,066 patients with TNF-receptor malignancies.
More immediately, the knock-on effect of an overall loss of protection against disease suggests that patients have greater appetite for cancer trials, according to Eric Julin, a research physician and immunologist at Massachusetts General Hospital. “Our study shows the importance of the limited space for new investigational drugs in what has become a limited field,” he said in a statement. “We already have multiple important drug candidates available and are on the verge of a new class of personalized immunotherapies that could generate some level of wider FDA approval. This vaccine failed to help these patients.”
About 16 million people are expected to be diagnosed with cancer in the United States this year, according to Cancer.gov. Nearly half of all cancer patients diagnosed are diagnosed with one of the deadliest forms of the disease, known as advanced or metastatic. These cancers take years to grow, but are the most painful and deadly for patients with access to a revolutionary, immunotherapeutic vaccine.
While the Cancer immunotherapy trials are still developing their effects, much of the competition among companies producing vaccines has already formed a powerful juggernaut. In addition to Moderna and Merck, a competing vaccine company, a handful of smaller drug firms, including Incyte and Keytruda, are already duking it out.
Moderna’s lead immunotherapy can be achieved without a booster shot, while its original trial involved both immune-boosting and immunity-destroying drugs administered in the same treatment. In 2012, only a couple of weeks after the vaccine’s launch, the Wall Street Journal hailed it as “not only a possibility to create effective cancer vaccines, but as a potential medical breakthrough that could change the way we treat millions of patients suffering from lung, breast, prostate, and colon cancers.” As the news from Monday’s trial emerged, the paper’s reporters wrote, “a nightmare of scientific underachievement,” reading: “[L]ove your doctor, take your meds. Isolated and unregulated, treatment by immune-boosting agents can easily lead to fatal side effects.”