It took longer for advanced melanoma to recur in patients treated with Bristol-Myers Squibb’s Opdivo (nivolumab) than in patients who received Yervoy, according to a Phase 3 clinical trial.
The findings applied to patients with stage 3b/c or stage 4 melanoma at high risk of recurrence after surgery. A company news release did not specify how much longer it took for the Opvido patients’ cancer to recur than the Yervoy patients.
Researchers are using the CheckMate 238 trial (NCT02388906) to compare the effectiveness of Opdivo and Yervoy (ipilimumab), which is also a Bristol-Meyers drug, as treatments for advanced melanoma. The U.S. Food and Drug Administration has already approved both therapies.
“These topline results support the potential promise of Opdivo as a treatment option for patients with high-risk surgically resected [removed] melanoma,” Dr. Vicki Goodman, who works on melanoma treatments at Bristol-Myers Squibb, said in the news release. “There remains an unmet need for additional options as the majority of stage III and resected stage IV high-risk melanoma patients experience disease recurrence after surgery.
“We are committed to researching therapies that may better meet the needs of this patient population and look forward to sharing these data with health authorities soon,” she added.
Surgeons removed the melanoma of the 906 patients in the CheckMate 238 trial, but they remained at high risk of the cancer recurring, researchers said. The main objective of the study was to see whether Opdivo would lengthen the time it took for patients’ melanoma to occur, compared with those on Yervoy.
Patients received four rounds of intravenous injections of Opdivo every two weeks or Yervoy every three weeks. Then they received the same therapies every 12 weeks until their disease recurred or they were unable to tolerate their treatment’s toxicity. This second stage of treatment lasted up to a year.
Researchers said it took longer for patients treated with Opdivo to have their disease return than those treated with Yervoy, meeting the trial’s primary objective.
Opdivo, an immuno-oncology therapy, blocks a protein called programmed death-1, or PD-1. The protein helps cancer cells survive by inhibiting the immune system’s ability to detect the malignancies. By blocking PD-1, Opdivo restores the body’s capacity to activate a strong anti-tumor response and fight cancer.
Because of its potential to bolster an immune system response against cancer, Bristol-Myers is evaluating Opdivo in a broad range of clinical trials dealing with a variety of cancers.
Melanoma starts with the abnormal growth of a skin cell known as a melanocyte that produces the skin pigment melanin. The American Cancer Society says about 87,110 new melanomas will be diagnosed in 2017 — 52,170 in men and 34,940 in women.
