So the FDA granted regular approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. What does that mean, exactly, and which patients will benefit?

To understand, let’s back up a few years to 2011, when the first immunotherapy, Yervoy (ipilimumab), was approved to treat metastatic melanoma. It was a seminal moment because it was the first treatment of any kind ever shown in a large randomized phase III clinical trial to improve overall survival in patients with metastatic melanoma, and it ushered in the era of immunotherapy. Because of these advances, approximately 30% of today’s Stage IV melanoma patients receiving immunotherapy will have long-term survival.

There are side effects of immunotherapies, and some —specifically those from Yervoy—can be very serious. Greater than 50% of patients receiving Yervoy, for example, have reported systemic adverse reactions such as fatigue, skin rashes, and dry mouth. Other more severe reactions that have been reported are colitis (inflammation to the bowel), hepatotoxicity (damage to the liver), endocrinopathies (inflammation to the pituitary gland, thyroid, or adrenal glands), and other inflammation reactions. Stage IV patients must wrestle with the risk of these side effects and commit to long-term monitoring if they take immunotherapy; it’s part of the reality of treatment.

But for melanoma patients who are Stage III or Stage IV resected, there has been a different calculus for treatment. These groups of patients may currently have no evidence of disease, but some have an appreciable chance of recurrence—though which patients will recur is of course not known. In the last six years, while Stage IV patients were seeing several new immunotherapies approved for treatment, Stage III approvals lagged. For a long time, only Interferon was approved for these patients—a drug with significant side effects that we now know did not increase overall survival. Then Yervoy was approved in the adjuvant setting, but some physicians opted not to give a potentially toxic treatment to a patient who may not ever recur; the cost-benefit ratio was just too low.

The excitement surrounding Opdivo’s approval is related to this cost-benefit ratio: For many people in these Stage III and Stage IV resected categories who have been waiting for the era of immunotherapy to reach them, finally there is a promising treatment to prevent recurrence with relatively minor side effects when compared to Yervoy.

Glossary

Adjuvant Therapy– Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy. Immunotherapy- A type of therapy that uses substances to stimulate or suppress the immune system to help the body fight cancer, infection, and other diseases. Some types of immunotherapy only target certain cells of the immune system. Others affect the immune system in a general way. Types of immunotherapy include cytokines, vaccines, bacillus Calmette-Guerin (BCG), and some monoclonal antibodies.

Metastatic– Having to do with metastasis, which is the spread of cancer from the primary site (place where it started) to other places in the body.

Phase III Clinical trial– A study that tests the safety and how well a new treatment works compared with a standard treatment. For example, phase III clinical trials may compare which group of patients has better survival rates or fewer side effects. In most cases, treatments move into phase III trials only after they meet the goals of phase I and II trials. Phase III clinical trials may include hundreds of people.

Recurrence– Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body.

Resection– Surgery to remove tissue or part or all of an organ.

For an extensive glossary of terms you may hear from your healthcare team click {here}