Opdivo and Yervoy May Improve Survival for Resected Stage 3/4 Melanoma

Among patients with resected stage 3 or 4 melanoma, treatment with immune-oncology agents such as Opdivo (nivolumab) and Yervoy (ipilimumab) demonstrated higher cure rates compared with those treated with a placebo.

According to study findings published in Journal of Oncology, “the analysis demonstrated that patients receiving [Opdivo] are more likely to be cured than those receiving [Yervoy] and those receiving [Yervoy] are more likely to be cured than those receiving [a] placebo,” study authors wrote.

Patients treated with Opdivo were more than twice as likely to be cured than patients receiving a placebo, as mentioned in the study.

In addition, similar cure rates for patients treated with Yervoy were estimated despite staging and dosing differences. Patients deemed cured exhibited no disease recurrence or mortality risks significantly different from the general population.

A mixture cure model study analysis was conducted by comparing two different trial results.

Results come from two large phase 3 trials CheckMate 238 (906 patients) and EORTC 18071 (951 patients). After a minimum follow-up of five years, in the first trial, estimated cure rates were 48.3% for patients treated with Opdivo and 38.2% for those treated with Yervoy. After a median follow up of 6.9 years, in second trial, estimated cure rates were 38% for Yervoy and 29.2% for the placebo. In an indirect comparison of the two trials, the odds of patients being cured were significantly higher with Opdivo than with those receiving a placebo.

When only looking at stage 3B/3C patients, the estimated five-year cure rates were 46.6% for Opdivo and 39.1% for Yervoy in CheckMate 238, and 35.4% for Yervoy and 25.6% for placebo in EORTC 18071. Counterintuitively, excluding stage 4 patients lowered Opdivo's cure rate, likely due to other factors like age, sex and BRAF mutation status.

In CheckMate 238, BRAF-mutant patients had estimated five-year cure rates of 49% for Opdivo and 42% for Yervoy, while BRAF wild-type patients had 41.5% for Opdivo and 34.7% for Yervoy. Opdivo consistently showed a roughly 7% increase in cure rate over Yervoy, regardless of BRAF mutation status as mentioned in the study.

Results from an indirect treatment comparison between each trial showed that treatment, age and disease stage (3C) all had a significant effect on the odds of being cured. In addition, sex, trial and other stage (3A, 4) effects on cure rates were not significant.

Patients were differentiated by age (younger than 65 years or at least 65 years), sex and disease stage (3A, 3B, 3C, 4). Stage 3C patients had lower cure odds than stage 3B. Stage 3A and 4 patients had non-significantly different cure odds compared to stage 3B, likely due to small sample size.

Treatments regiments consisted of Opdivo 3 milligrams/kilograms (mg/kg) once every two weeks or Yervoy 10 mg/kg once every three weeks for four doses and then once every 12 weeks starting at week 24.

Reference:

“Estimating Long-Term Survivorship Rates Among Patients With Resected Stage III/IV Melanoma: Analyses From CheckMate 238 and European Organization for Research and Treatment of Cancer 18071 Trials” by Dr. Jeffrey S. Weber, et al., Journal of Clinical Oncology.

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