The recent availability of immunotherapy for metastatic melanoma has given new hope to patients for living longer with a deadly disease that once had a bleak prognosis. Research shows that approximately half of patients with advanced melanoma who were given what has become the standard of care – a combination of the anti–CTLA-4 drug ipilimumab that was approved in 2011 and the anti–PD-1 nivolumab, which came to market in 2014 – were still alive 5 years later.1 “Before 2011, there was no treatment for metastatic melanoma that improved survival rates. It was a death sentence,” said Douglas Johnson, MD, who leads the melanoma clinical research program at Vanderbilt-Ingram Cancer Center in Nashville, Tennessee. “But with the combination, even patients with brain metastasis can respond to treatment.”
Yet the lack of long-term data about how to choose the right protocol for patients has frustrated oncologists who’ve had to rely on limited research or trial and error with drugs that can routinely cost more than $100,000 per year. “If you’ve got younger and healthier patients who want to be maximally aggressive, you might give them the combination, which has more side effects,” said Dr Johnson. If the drugs become toxic, they can create an autoimmune response, causing inflammation and resulting diarrhea, rash, cough, shortness of breath, or low thyroid production. “We also have to look at how aggressive the disease is and how big the tumors are. There are so many unanswered questions,” he said.
“There is no perfect marker to decide between combination therapy and single-agent immune therapy. We have to look at the patient’s age and ability to tolerate therapy, and how aggressive the disease appears. There are so many unanswered questions,” he added.
Yet posters presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting aim to offer some insights, especially in regard to whether a longer duration of treatment improves outcomes, and the role of patients’ body composition as it relates to outcomes.
The current standard of care for the length of treatment is 2 years, which is based on the regimen studied in most FDA trials. But Allison Betof Warner, MD, PhD, a medical oncologist at Memorial Sloan Kettering Cancer Center, New York, New York, wanted to understand what happened to patients who stopped treatment sooner, after they had successfully responded to treatment with a single anti–PD-1 drug. “In melanoma, there’s been increased interest in discontinuing treatment when it’s safe. Do we really need to complete 2 years?” she said. “Now that we’re seeing patients surviving for years, asking them to come in every 3 weeks for an infusion is not only anxiety-inducing, but it’s expensive for patients and the system.”