OPDIVO Approved For Advanced Esophageal Cancer
- The Immunotherapy drug OPDIVO has been approved by the FDA for esophageal cancer that is advanced, has recurred, or is not able to be treated with surgery.
- A clinical trial showed that patients who used OPDIVO saw an increased overall survival rate as opposed to patients who underwent standard chemotherapy alone.
- Esophageal cancer is often caught late, and the 5-year survival rate of those with the advanced disease is 5%.
The Food and Drug Administration (FDA) has approved the immunotherapy medication OPDIVO (nivolumab) for the treatment of advanced/metastatic esophageal squamous cell carcinoma (ESCC) — which doctors say is one of the most significant drug approvals for this disease in decades. This drug has been approved for ESCC patients who had previously undergone treatment, but their disease has progressed. Checkpoint inhibitors such as OPDIVO switch off a part of the immune system that is blocking the body from fighting the cancer. This allows immune cells to recognize and eliminate cancer cells more effectively.Read More
“I think it’s a very significant step towards an improvement in survival rates,” says Dr. Mukherjee. “I have personally used checkpoint inhibitors in patients for esophageal cancer and the results have been very satisfactory. Both these drugs work by boosting your immune system. They do not directly go and kill the cancer cells. Rather, they basically boost your T-cells, which are a subset of immune cells, [and] they release breaks on T-cells so that they’re on fire and go up to your cancer and kill them.”
How Effective Is Opdivo For Esophageal Cancer?
This approval stems from a clinical trial, which showed patients who took OPDIVO lived longer than those treated by standard chemotherapy alone (10.9 months vs. 8.4 months). However, what makes this approval different than fellow immunotherapy drug Keytruda (pembrolizumab), which was approved by the FDA last year for ESCC patients with the PD-L1 protein, is that patients will be able to access OPDIVO for treatment regardless if they have the PD-L1 protein — a protein receptor found on the surface of immune cells.
Why Haven’t More Drugs For Esophageal Cancer Been Approved?
Unlike other cancers, esophageal cancer has not seen as many new drug approvals over the years. However, the approval of Keytruda and now OPDIVO are promising steps in creating more accessible treatment options for those battling the disease.
“If you compare it with other cancers such as lung cancer for example, we haven’t had that many agents approved in esophageal cancer,” Dr. Mukherjee says. “Why is that? That’s because many studies that were run were negative studies, and we didn’t really see meaningful improvement in survival. Also, you have to understand that in the United States esophageal cancer is still somewhat rare. So, those who run clinical trials often find it difficult to enroll patients in clinical trials because of how rare it is.”
Dr. Mukherjee believes these newly approved drugs will serve as standard treatment for those whose disease has recurred after a first round of treatment. “Right now what we’re going to do is use it more generally, but eventually I’m pretty sure we’ll learn which patients will benefit most from this drug,” Dr. Mukherjee says.
While some people may question if the few months difference in overall survival is significant, Dr. Mukherjee points out that it’s important to look at the “tail end of the curve” — meaning examining those who have had long-term positive responses to checkpoint inhibitors. For some patients, life expectancy could increase up to seven months. As opposed to chemotherapy, where a person’s body can sometimes become resistant to the treatment, immune checkpoint inhibitors can cause a person to positively respond to treatment longer.
“That’s something that is very encouraging, and something very important,” Dr. Mukherjee says. “I would look at that. Yes, it’s true that people look at median survival, and it may not sound that great, but in our world anything that improves survival in patients whose disease already progress after chemotherapy, I think that’s pretty remarkable.”