Opdivo has been shown to improve survival in patients with mesothelioma who have progressed on first-line chemotherapy.
According to study results, immunotherapy with Opdivo (nivolumab) may be a useful treatment for individuals with malignant mesothelioma whose disease worsened on first-line therapy.
In an interview with CURE®, Dean A. Fennell, a professor of thoracic medical oncology and director of a mesothelioma research program at the University of Leicester in the United Kingdom, said, “Immunotherapy had demonstrated potentially useful activity in patients with mesothelioma who had growth of their tumors after initial (first-line) chemotherapy.” “To date, no treatment has been licensed for the treatment of these patients.” As a result, this is a clinical environment with unmet demand.”
The CONFIRM trial findings were published in Lancet Oncology, and they represent “the first phase 3 clinical trial to have showed an improvement in survival for patients with recurrent mesothelioma,” according to Fennell, one of the trial’s researchers.
Although Opdivo may be an effective therapy option for patients with malignant mesothelioma on its own, the Food and Drug Administration (FDA) has not approved it for this specific usage. It is worth noting that Opdivo has been licensed in combination with another immunotherapy for individuals with malignant mesothelioma.
“It’s worth noting that immunotherapy with (Opdivo) and ipilimumab (Yervoy) has been approved by the FDA,” Fennell added. “As a result, this treatment is a first-line option for patients all over the world.” As with other cancers, immunotherapy is likely to find a home in the first-line setting for patients.”
Researchers analyzed data from 332 individuals with relapsed malignant mesothelioma in the CONFIRM study. These individuals were randomly randomized to either Opdivo (221 patients; median age, 70 years; 76% men) or placebo medication (111 patients, median age, 71 years; 78 percent men). Treatment was given to both groups every two weeks until disease progression or a maximum of 12 months, whichever came first.
The primary goals of this experiment were to evaluate progression-free survival (the time between treatment assignment and disease progression or death) and overall survival (time from treatment assignment to all-cause death). Patients were monitored for an average of 11.6 months.
During the experiment, participants received a median of six Opdivo doses and four placebo doses. Opdivo patients had a three-month median progression-free survival compared to 1.8 months for placebo patients. Furthermore, the median overall survival in the Opdivo group was 10.2 months against 6.9 months in the placebo group.
Diarrhea (3 percent versus 2 percent, respectively) and infusion-related events were the most commonly reported severe or worse adverse effects associated with Opdivo treatment in individuals assigned either Opdivo or placebo (3 percent versus 0 percent , respectively). Serious adverse events occurred in 41 percent of Opdivo participants versus 44 percent of placebo patients. In either group, no one died as a result of the treatment
“(Opdivo’s) toxicity was in line with expected, authorised therapy,” Fennell said. “(Opdivo’s) side effects were managed.” It should be highlighted that the overall severe (side effect) rate was greater for patients receiving placebo rather than active treatment (Opdivo). This indicates the treatment’s overall safety, which was well tolerated.”
Despite these significant discoveries, Fennell stated that additional research in this area is required.
“It’s critical that we understand why patients with mesothelioma respond to immunotherapy at all,” he says. “Understanding this could assist us in personalizing therapy (improving cost effectiveness and efficacy); developing better combinations to improve the level of predicted benefit for patients; and developing immunotherapies that can overcome resistance that develops with first-line therapy.”
Fennell highlighted that new medicines for mesothelioma patients mark an exciting time in this field.
“New mesothelioma treatments are being reported at an increasing rate, which is quite welcome with associated approvals in clinical outcome,” he added. “This is very encouraging and is likely to continue as we gain a better understanding of biology and examine more promising new medicines, particularly in the relapsed scenario where there is still a paucity of FDA-approved medication.”