Even after patients with stage 2B or 2C melanoma have their disease surgically removed, there is still a chance that it can come back, highlighting the need for post-surgical — also known as “adjuvant” — therapies. With that, the Food and Drug Administration (FDA) approved adjuvant Opdivo (nivolumab) for this patient population.
“There’s always a risk, with every cancer, that it can migrate into the tiny blood or lymph vessels and make its way outside of where the surgery was,” Dr. Craig Devoe, associate professor of Medicine at the R.J. Zuckerburg Cancer Center, said in an interview with CURE®. “So, we give preventative therapy, adjuvant therapy, to mitigate that risk.”
Preventing Recurrence “Just Makes Sense”
Devoe explained that some patients with stage 2 or 3 melanoma are at a higher risk of disease relapse, especially if they have a very thick melanoma or if the cancer has spread to the nearby lymph nodes. For these patients, having a post-surgical treatment option “just makes sense.”
Opdivo is not the only adjuvant treatment option for this patient population. In fact, back in December 2021, the FDA approved another immunotherapy agent, Keytruda (pembrolizumab) for individuals aged 12 or older who have stage 2B, 2C or 3 melanoma that was fully removed via surgery.
Both Opdivo and Keytruda are immune checkpoint inhibitors, meaning that they block certain proteins on cancer cells that allow the tumors to hide from the immune system. In doing so, the immune system can then find and fight the cancer.
Deciding between adjuvant Opdivo and Keytruda often comes down to patient and provider preference, explained Devoe. Aspects such as dosing schedule can be considered when making that decision. The drugs are given intravenously: Keytruda can be given every three or six weeks, while Opdivo is every four or two weeks.
“It’s a bit of a dealer’s choice on how people will decide, as long as the National Comprehensive Cancer Network (NCCN) Guidelines incorporate Opdivo as a category 1 (drug), meaning that they fully approve it,” Devoe said. “Then, you could choose either one of these in making these decisions.”
While the FDA approval allows for the drug to be brought to the market in a certain indication, NCCN guidelines may play a role in insurance coverage. According to the NCCN’s website, “The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care — including physicians, nurses, pharmacists, payers, patients and their families — with the ultimate goal of improving patient care and outcomes.”
Opdivo Boosts Relapse-Free Survival
The October 2023 approval of Opdivo was based on findings from the phase 3 CheckMate-76K trial, which showed that Opdivo improved relapse-free survival (time a patient lives without experiencing disease relapse) compared with placebo.
However, Devoe noted that relapse-free survival is a different outcome than overall survival.
“Relapse-free survival … is great, because it means you are living long without the cancer coming back, whereas overall survival just means that you’re living longer,” Devoe explained. “Relapse-free survival does not necessarily mean that you’re living longer, it just means that you’re living longer without the cancer.”
Ultimately, patients with stage 2B or 2C melanoma should talk with their treatment team to determine if adjuvant therapy could improve their cancer-related outcomes.
“Surgeons may not refer patients to a medical oncologist if they’re not aware that stage 2 patients can now have access to adjuvant therapy with Opdivo or Keytruda,” Devoe said. “So patients should be like an informed consumer and let their surgeon know — or even just ask the question — ‘should I be referred to a medical oncologist?’”
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