Written by Amy Norton HealthDay Reporter >
MONDAY, January 10, 2022 — For people diagnosed with advanced skin cancer, a combination of two immunotherapy drugs can double the time the cancer remains free of progression, according to a clinical trial.
The treatment combines two drugs known as immune checkpoint inhibitors. One, called nivolumab (Opdivo), is already the standard for advanced melanoma. The other, relatlimab, is not yet approved.
But based on the new trial, the FDA granted it a priority review.
The study included 714 patients with previously untreated melanoma that was inoperable or had spread to other sites of the body. The researchers found that patients treated with Opdivo/relatlimab usually went twice as far without getting worse, versus those treated with Opdivo alone.
They remained progression-free for an average of 10 months, compared to 4.6 months in the Opdivo-only group.
“median” means that half of the patients went longer without progression, while half experienced faster progression.
After one year, about 48% of patients in the combination group were still progression-free, compared to 36% of patients in Opdivo alone.
Experts said they expect the new drug will win approval and the combination therapy will become standard treatment.
“The difference in progression-free survival is really noticeable,” said lead researcher Dr. Hussein Toby, of the University of Texas MD Anderson Cancer Center at Houston.
Skin cancer is the most dangerous type of skin cancer. Approximately 78,000 new cases occur in the United States each year, according to the US Centers for Disease Control and Prevention.
Currently, the standard first-line treatment for patients with advanced skin cancer is either with Opdivo alone, or in combination with another medicine called ipilimumab (Yervoy). This combo has been shown in previous research to extend the lives of patients with advanced melanoma, versus Opdivo alone. The problem is the high rate of side effects: In studies, more than half of patients had side effects serious enough to need medical attention.
In the current trial, only 19% of patients treated with Opdivo/relatlimab had serious side effects – including hepatitis, extreme tiredness and diarrhea.
“The toxicity is lower, and that’s exciting,” Toby said.
All three drugs — Opdivo, Yervoy and relatlimab — are immune checkpoint inhibitors, which means they loosen the immune system’s “brake,” releasing T cells to find and destroy cancer cells.
Toby explained that each drug targets a different protein in the immune system.
Relatlimab is one of a new group of drugs in development that inhibits a protein called LAG-3. The current trial is the first to show that adding a LAG-3 inhibitor to Opdivo can benefit patients with advanced melanoma.
“Understanding the immune system and its role in cancer has led to new drugs that have already improved outcomes in certain types of cancer,” said Dr. Julie Gralow, chief medical officer of the American Society of Clinical Oncology.
Skin cancer is one of those cancers. For this disease, the immune checkpoint inhibitors have been “real home workouts,” Gralow said.
She said she fully expects relatlimab to be approved, and that the new combination of drugs “will undoubtedly change the standard of care.”
As more treatments that target the immune system become available for melanoma and some other cancers, Gralow noted, the next steps will be figuring out how best to use them — in which groups, and at what stage of the disease, for example.
The new study was funded by drug maker Bristol-Myers Squibb. Posted on January 6 in New England Journal of Medicine.
Gralow said it’s still not known if this combination can extend patients’ overall survival.
The combination of Opdivo/Yervoy has been shown to enhance overall survival in advanced melanoma. In the trials, 52% of patients were still alive after five years, compared to 44% of those who received Opdivo alone.
But while more is known about the long-term efficacy of this combination, the reduced toxicity of Opdivo/relatlimab “would be attractive to many patients,” Tawbi said.
He didn’t expect the combination, once approved, to completely replace Opdivo/Yervoy in the treatment of advanced melanoma. First, the latter has been shown to enhance overall survival in patients whose cancer has spread to the brain.
Toby agreed that knowing the timing and arrangement of new treatments for advanced melanoma is essential and will take time.
Immune checkpoint inhibitors also come with a hefty price tag, with options currently available costing more than $100,000 per year.
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Posted Jan 2022