Moderna’s experimental cell therapy stimulates T cells to attack cancerous tumors, according to an FDA application Moderna submitted for approval to market the product. The technology still hasn’t been rigorously tested in humans, but if approved by the FDA, the future of clinical-stage cancer treatment could be changing.
The application suggests Moderna’s cell therapy could be a popular medicine as soon as next year. In the future, cells might be programmed with a secreted cancerkiller that would do more than get rid of tumors — like chemotherapy, Moderna’s cell therapy would then help the body’s immune system kill an entire cancer cell by itself. And Moderna says, it won’t require “boots on the ground” — a key difference from Pfizer’s immunotherapy version of the drug — because Moderna’s cells would then be spread across the body like an immune response.
Without any solid medical proof that Moderna’s immune therapy will help beat cancer in humans, it remains to be seen how easily the drug will gain wider acceptance. But with treatments developed through “moon shot” approaches, like Theravance’s inhaled antibiotic, it’s possible that they might succeed in fighting cancers that aren’t amenable to drug development. More like Moderna, these early-stage anti-cancer therapies might offer new hope to desperate patients and doctors, but only time will tell if they have staying power.
1. In the first year since starting treatment, patients receiving Moderna’s treatment lived an average of 4.4 months longer than patients in the placebo group (5.8 months versus 4.1 months)
2. In a similar 11-week randomized trial of 260 patients with advanced melanoma or head and neck cancer receiving Pfizer’s breast cancer immunotherapy, 25 percent of the people in the placebo group had a progression-free survival rate of 4.3 months compared to 16 percent of those treated with immunotherapy.
3. Patients receiving chemotherapy plus immunotherapy plus checkpoint inhibitor experienced a 47 percent decrease in severe serious adverse events, with the most severe of these causing a temporary loss of appetite and nausea in 17 percent of patients. The most severe of these events were 3.5 percent of those in the chemotherapy combination group. “We’re seeing this very early robustly occurring,” according to Oncologist Dr. Mitul Sinha. “When you combine immunotherapy and chemo, you can go one to two years without seeing complete tumor regression.”
4. Whereas Pfizer’s immunotherapy was initially tested as an adjunct treatment for 1 percent of people with advanced melanoma, Moderna’s drug, if approved by the FDA, will be used in 5 to 6 percent of patients with advanced cancer.
Moderna aims to market its cell therapy for patients with myeloma, non-Hodgkin lymphoma, breast cancer, and some types of pancreatic cancer, alongside a more complicated immunotherapy of its own. Researchers aren’t quite sure how the cell therapy works. However, the company’s Phase 1 study showed that 4.3 percent of patients in the company’s trial had their cancers go into complete remission when enrolled into the program, which was compared to patients in a control group receiving the oral cancer medication, dasatinib. Because the trials involved only a relatively small number of patients in the the United States, the success rates in these early studies could vary greatly from those in a larger trial.
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